SMALL MOLECULE ANALYTICAL TESTING

We offer analytical testing services for drugs, including method development, analytical validation, HPLC-MS analysis, GC analysis, impurity profiling, stability studies, batch release, and more. Our CDMO services cover all stages: candidate discovery, clinical trial materials, regulatory submissions, post-approval studies, and commercial supply. 

Our analytical testing services can be specifically tailored to our partner’s needs based on:

  • Development phase
  • Material type
  • Standard versus specialized testing
  • Integrated analytical/manufacturing, stand-alone analytical programs, or ad hoc analyses
commercial manufacturing - image of vials being manufactured

Overview

Global Analytical Network – US & Centers: Our expansive network provides comprehensive analytical testing services, ensuring global reach and 2 full scale analytical facilities in the USA.

Tailored Stability Programs for Small Molecules: We design stability programs that incorporate analytical services to assess the longevity and efficacy of small molecules.

20+ Years Operational Excellence: Our two decades of experience in analytical testing translate to unparalleled quality and reliability for all your analytical challenges.

Standard and Customized Services: Whether it’s standard analytical testing or customized analytical services, we cater to a wide spectrum of needs from placebos to controlled drugs.

Rapid Microbial Methods (RMM): Our analytical services include RMM, accelerating the pace of microbial detection to support Phase I clinical supply manufacturing.

Expertise with Various Formulations: Our analytical testing proficiency encompasses a diverse range of formulations, including oral solids (immediate and sustained release), oral solutions, and softgels.

Material Categories:

All Hazard Categories: Our analytical services are equipped to handle materials across many categories, ensuring comprehensive analytical testing for any substance.

DEA Category I-V: We provide meticulous analytical testing services for substances classified under DEA Categories I-V, adhering to the strictest regulatory standards.

Photosensitive Compounds: Our analytical services include specialized testing protocols for photosensitive compounds, protecting their integrity under various light conditions.

Moisture Sensitive Compounds: We offer analytical testing solutions for moisture sensitive compounds, ensuring their stability and quality in different environmental conditions.

Oxidation Sensitive Compounds: Our analytical services are designed to rigorously test oxidation sensitive compounds, preventing degradation and ensuring efficacy.

Analytical Method Development and Validation: Our analytical services are not just limited to testing; we also specialize in the development and validation of robust analytical methods.

Regulatory Compliance: With our analytical testing, we ensure that all products meet stringent regulatory standards, providing peace of mind and market readiness.

Environmental Testing: Our analytical services extend to environmental testing, helping you assess the impact of your products on the environment.

Data Integrity and Reporting: We uphold the highest standards of data integrity, with analytical testing results that are accurate, reproducible, and meticulously reported.

Activities By Development Phase

Single Point of Contact for All Phases: Renejix offers a dedicated point of contact to streamline analytical testing processes throughout all phases of drug development.

Assurances that Current Guidelines are Met: Our analytical services are aligned with current guidelines, ensuring compliance with ICH requirements and other regulatory standards.

Effective Communication: We prioritize clear and effective communication to facilitate analytical testing activities and project success.

Preclinical

Non-GMP: Renejix provides non-GMP analytical testing services for early-stage development, focusing on flexibility and innovation.

GLP: Our Good Laboratory Practice (GLP) analytical services ensure that preclinical data is reliable and regulatory compliant.

Preformulation and Solid State Characterization: Analytical testing at Renejix includes comprehensive preformulation studies and solid-state characterization to predict product performance.

Early Phase Clinical

Phase-Appropriate Validation: Our analytical services offer phase-appropriate validation, ensuring that methods are suitable for the stage of clinical development.

Assessment of Prototype Formulations: Renejix’s analytical testing capabilities include thorough assessment of prototype formulations to optimize drug delivery.

First-in-Man Studies: We provide analytical services that support first-in-man studies, focusing on safety and efficacy.

Clinical Trial Material: Analytical testing for clinical trial materials at Renejix is conducted with precision and care to support successful trials.

Late Phase Clinical / Pre-Commercial

Registration: Our analytical services play a crucial role in the registration process, providing the necessary testing to meet regulatory demands.

Design of Experiments/Quality by Design: Renejix employs analytical testing within design of experiments to ensure quality by design in drug development.

Process Validation: We offer analytical services that include process validation, confirming that production processes yield consistent and high-quality products.

Photostability: Analytical testing for photostability at Renejix ensures that products remain stable under light exposure.

Temperature Excursions/Shipping Studies: Our analytical services assess the impact of temperature excursions during shipping to guarantee product integrity.

Shelf-life, Expiry Dating: Renejix’s analytical testing determines shelf-life and expiry dating, critical for product safety and efficacy.

Packaging Component Assessment/Interactions: We provide analytical services to evaluate packaging components and their interactions with the drug product.

Commercial

Phase IV / Line Extension: Our analytical testing supports Phase IV studies and line extensions, ensuring ongoing product quality and monitoring.

Additional topics to consider:

Analytical Testing for Bioequivalence: Renejix offers analytical services to demonstrate bioequivalence, a key factor in generic drug approval.

Impurity Profiling and Identification: Our analytical testing includes impurity profiling, identifying and quantifying impurities for product quality.

Extractables and Leachables Studies: Renejix’s analytical services conduct studies on extractables and leachables to ensure product and packaging safety.

Specialized Testing

Assessment of Abuse-Deterrent Formulations: Our analytical services are critical in the assessment of abuse-deterrent formulations, ensuring they meet regulatory standards and protect patients.

Metals Testing: We provide comprehensive metals testing as part of our analytical testing suite, identifying and quantifying metal contaminants in products.

Dissolution Testing: Our analytical services include dissolution testing, which is essential for evaluating product performance and ensuring consistent drug release.

Litigation Testing: Renejix offers specialized analytical testing to support litigation cases, providing robust data and expert analysis.

Particle Size Distribution Analysis: Our analytical services utilize advanced technologies for particle size distribution analysis, a key factor in product quality and performance.

Extractables and Leachables Testing: We conduct thorough analytical testing for extractables and leachables, ensuring product and packaging safety.

Chemical Characterization: Our analytical services provide detailed chemical characterization to understand and improve product formulations.

Stability Testing: Renejix’s analytical testing includes stability studies to determine the shelf life and storage conditions of products.

Method Transfer and Optimization: We offer analytical services for method transfer and optimization, ensuring methods are robust across different laboratory settings.

Analytical Techniques And Instrumentation

Chromatography

  • High Performance Liquid Chromatography (HPLC): Our analytical services offer HPLC, a cornerstone of analytical testing, providing high-resolution results for complex mixtures.
  • Ultra High Performance Liquid Chromatography (UHPLC): With UHPLC, our analytical testing capabilities are enhanced, allowing for faster and more efficient separation of compounds.
  • Rapid Resolution Liquid Chromatography (RRLC): RRLC is part of our advanced analytical services, delivering rapid and high-resolution chromatographic testing.
  • Wide Range of HPLC Detectors: Our analytical testing utilizes a variety of HPLC detectors, including UV, PDA, Fluorescence, CAD, RI, and ELSD, to meet diverse analytical needs.
  • Gas Chromatography (GC): GC is a key component of our analytical services, ideal for the separation and analysis of volatile compounds.
  • Thin Layer Chromatography (TLC): TLC is included in our analytical testing services for quick screening and identification of compounds in a sample.
  • Capillary Electrophoresis (CE): Our analytical services use CE for the high-efficiency separation of molecules, based on their size-to-charge ratio.

CFR Part 11 Compliant Chromatography Data Acquisition System

Organic Spectroscopy:

  • Nuclear Magnetic Resonance Spectroscopy (NMR): Our NMR analytical services provide detailed molecular structure elucidation, which is essential for complex analytical testing scenarios.
  • Fourier Transform Infrared Spectrophotometry (FTIR): FTIR is a pivotal part of our analytical testing suite, offering rapid and reliable identification of organic and inorganic substances.
  • UV/VIS Spectrophotometry: Our analytical services include UV/VIS spectrophotometry, a fundamental technique for quantitative and qualitative analysis in various samples
    .
  • Polarimetry: As part of our analytical testing capabilities, polarimetry is utilized to determine the optical rotation and concentration of optically active substances.
  • Near Infrared (NIR): NIR analytical services are offered to provide non-destructive and rapid analysis of pharmaceutical and agricultural products.
  • Raman Spectroscopy: Our Raman spectroscopy analytical testing is ideal for characterizing chemical compositions and monitoring changes in material properties.
  • Mass Spectrometry: Mass spectrometry analytical services at our facility enable precise quantification and detection of compounds even at trace levels.
  • X-Ray Powder Diffraction: X-ray powder diffraction is included in our analytical testing to determine crystalline structures and analyze solid-state compounds.

Dissolution:

  • USP Apparatus 1, 2, 3, 4, 5, 6, 7: Our comprehensive dissolution analytical services utilize all USP Apparatus types to ensure versatile and accurate analytical testing for a variety of dosage forms.
  • F2 Testing: F2 testing is a key component of our analytical testing suite, providing critical comparative dissolution profiles for pharmaceutical products.
  • Biowaivers: Our analytical services support biowaiver applications by conducting rigorous dissolution testing to demonstrate bioequivalence without the need for in vivo studies.
  • Intrinsic Dissolution: We offer intrinsic dissolution analytical testing, an essential service for understanding the dissolution rate of pure pharmaceutical compounds.

Karl Fischer:

  • Volumetric Karl Fischer: Our volumetric Karl Fischer analytical services provide precise water content determination, a critical aspect of many analytical testing protocols.
  • Coulometric Karl Fischer: For low moisture content, our coulometric Karl Fischer analytical testing offers high sensitivity and accuracy.
  • Evaporative Karl Fischer: Our evaporative Karl Fischer analytical services are ideal for samples that are challenging to dissolve, ensuring comprehensive moisture analysis.

Physical Testing:

  • Hardness Testing: Our analytical services include hardness testing, which is a crucial part of the analytical testing process for evaluating tablet strength and durability.
  • Friability Testing: Friability testing is an essential analytical service that we provide to assess the physical integrity of tablets under stress.
  • Particulates (HIAC): High Accuracy Airborne Particle Counting (HIAC) is a key component of our analytical testing services, ensuring the safety and cleanliness of pharmaceutical products.
  • Osmolality/Osmolarity Testing: Our analytical services measure osmolality/osmolarity, providing valuable insights into the concentration of osmotically active particles in solutions.
  • Disintegration Testing: We offer disintegration testing as part of our analytical testing suite to evaluate the time it takes for tablets or capsules to break down in the body.
  • Viscometers: Our analytical services utilize viscometers to measure the viscosity of liquids, an important parameter in the quality control of liquid formulations.

Particle Analysis:

  • Malvern: Our Malvern analytical services provide advanced laser diffraction techniques for precise particle size analysis, a critical component of comprehensive analytical testing.
  • Microscopy: Microscopy is a fundamental part of our analytical testing capabilities, offering high-resolution imaging for detailed particle characterization.
  • Sieving: Sieving is included in our analytical services to determine particle size distribution, a vital test for quality control in manufacturing processes.
  • HIAC (High Accuracy Airborne Particle Counting): HIAC is a key analytical testing service we offer, ensuring accurate measurement of particulate contamination in samples.
  • Cascade Impaction: Our analytical services utilize cascade impaction for aerodynamic particle size distribution testing, essential for inhalation product development.

Thermal Analysis:

  • Differential Scanning Calorimetry (DSC): Our DSC analytical services provide crucial insights into the thermal properties of materials, a vital part of the analytical testing process for stability and compatibility studies.
  • Thermogravimetric Analysis (TGA): TGA is an essential analytical testing technique we offer, allowing for the precise measurement of weight changes in a material as a function of temperature.
  • Dynamic Vapor Desorption (DVS): Our DVS analytical services are key for understanding sorption properties of materials, providing valuable data for product performance and shelf life.

Metals Analysis:

  • Inductively Coupled Plasma Mass Spectrometry (ICP-MS): Our ICP-MS analytical services offer unmatched sensitivity and precision, making it a cornerstone of metals analytical testing for trace element detection.
  • Inductively Coupled Plasma Atomic Emission Spectrometry (ICP-AES/OES): ICP-AES/OES is integral to our analytical testing suite, providing rapid and accurate elemental analysis across a wide dynamic range.
  • Microwave Digestion: Microwave digestion is a preparatory step in our analytical services that enhances the efficiency and safety of sample preparation for subsequent metals analysis.
  • Graphite Furnace Atomic Absorption Spectrometry (GFAAS): GFAAS enhances our analytical testing capabilities with its high sensitivity for detecting trace metals in complex matrices.
  • Cold Vapor Atomic Absorption Spectrometry (CVAAS): Our CVAAS analytical services are specialized for mercury analysis, offering high sensitivity and selectivity in analytical testing.
  • Flame Atomic Absorption Spectrometry (FAAS): FAAS is a robust part of our analytical services, ideal for quantifying metals in various samples through analytical testing.

Microscopy:

  • Light Microscopy: Our light microscopy analytical services provide a fundamental approach to visualizing sample details, playing a crucial role in the initial stages of analytical testing.
  • Hot Stage/Optical Microscopy: Hot stage/optical microscopy is a specialized analytical testing service we offer, enabling the observation of samples under controlled heating conditions.
  • Cold Stage/Optical Microscopy: Our cold stage/optical microscopy analytical services allow for the examination of samples at low temperatures, essential for understanding material behavior in different thermal environments.

Microbiology:

  • Antimicrobial Efficacy: Our analytical services rigorously evaluate antimicrobial efficacy, ensuring that your products meet the required standards for inhibiting microbial growth.
  • Bioburden Testing: Bioburden analytical testing is a critical service we provide, quantifying the microbial load on pharmaceutical products before sterilization.
  • Container Closure Integrity Testing: Container closure integrity is an essential part of our analytical services, safeguarding against microbial contamination throughout a product’s shelf life.
  • Microbial Limits Testing (MLT): MLT is a fundamental analytical testing procedure we perform to determine acceptable levels of microbial contamination in non-sterile products.
  • Sterility Testing: Our sterility analytical testing ensures that sterile products are free of viable contaminating microorganisms, a crucial service for patient safety.
  • Microbial Identification: We offer microbial identification as part of our analytical services, utilizing advanced techniques to pinpoint the specific microorganisms present in samples.

Stability Storage & Testing:

  • Stability Storage: Our stability storage analytical services provide a controlled environment to assess how various storage conditions affect your product’s shelf life and efficacy.
  • Accelerated Stability Testing: As part of our analytical testing, we conduct accelerated stability studies to predict the long-term behavior of products under normal storage conditions.
  • Real-Time Stability Testing: Our real-time stability analytical services monitor products over their intended shelf life, ensuring they meet quality standards until expiry.
  • Photostability Testing: We include photostability testing in our analytical services to evaluate the effects of light exposure on product stability.
  • Temperature Cycling Studies: Our analytical testing includes temperature cycling to determine the impact of temperature fluctuations on product integrity.
  • Humidity Testing: Humidity control is a critical aspect of our analytical services, assessing the effect of moisture on product stability and packaging.
  • Freeze-Thaw Cycle Testing: We offer freeze-thaw cycle analytical testing to understand how freezing and thawing may affect product quality and efficacy.

Activities By material

TEST ACTIVE PHARMACEUTICAL PRODUCTS FASTER AND MORE EFFICIENTLY

Our comprehensive suite of services includes GMP/GLP-analytical microbiology services and specialty services. Our seasoned pharmaceutical team provides method development support, consulting, problem-solving expertise, and analytical flexibility. Opt for our routine analytical testing methods or tailor a program to your specific sampling and testing requirements.

COMPENDIAL TESTING

  • Compendial Testing: Our compendial analytical testing ensures that your products adhere to established pharmacopeia standards, providing reliable and consistent results.
  • Microbiology Testing: We offer microbiology analytical services to detect and quantify microbial presence, ensuring product safety and compliance.

DRUG SUBSTANCE / DRUG PRODUCT TESTING

  • Compendial Testing: Our analytical services include rigorous compendial testing to verify that drug substances and products meet all necessary pharmacopeial specifications.
  • Method Development / Validation / Transfer: We specialize in analytical testing method development, validation, and transfer, ensuring robust and accurate analytical procedures.
  • Structure Characterization: Our analytical services provide detailed structure characterization to elucidate the molecular composition of drug substances.
  • Release & Stability Testing: We conduct release and stability analytical testing to ensure that drug products maintain their integrity and efficacy throughout their shelf life.

MANUFACTURING SUPPORT TESTING

  • Excipient Compatibility: Our analytical testing evaluates excipient compatibility, crucial for the successful formulation of drug products.
  • In-Process Testing: We offer in-process analytical services to monitor and optimize manufacturing processes, ensuring product quality.
  • Blend/Content Uniformity: Our analytical testing includes blend and content uniformity assessments, essential for ensuring consistent drug distribution within a batch.
  • Feasibility/Prototype Stability: We provide feasibility and prototype stability analytical services to predict how formulations will perform during development.
  • Cleaning Verification/Validation: Our analytical testing encompasses cleaning verification and validation, confirming the absence of contaminants post-manufacturing.
  • Process Validation, DOE, QbD: We integrate analytical services into process validation, Design of Experiments (DOE), and Quality by Design (QbD) to enhance product development.
  • Container/Closure Evaluation: Our analytical testing includes container/closure evaluation to ensure the integrity and compatibility of packaging with drug products.
  • Packaging Component Screening: We conduct packaging component screening as part of our analytical services, assessing the suitability of packaging materials for drug products.

Global Analytical Network – US & Centers: Our expansive network provides comprehensive analytical testing services, ensuring global reach and 2 full scale analytical facilities in the USA.

Tailored Stability Programs for Small Molecules: We design stability programs that incorporate analytical services to assess the longevity and efficacy of small molecules.

20+ Years Operational Excellence: Our two decades of experience in analytical testing translate to unparalleled quality and reliability for all your analytical challenges.

Standard and Customized Services: Whether it’s standard analytical testing or customized analytical services, we cater to a wide spectrum of needs from placebos to controlled drugs.

Rapid Microbial Methods (RMM): Our analytical services include RMM, accelerating the pace of microbial detection to support Phase I clinical supply manufacturing.

Expertise with Various Formulations: Our analytical testing proficiency encompasses a diverse range of formulations, including oral solids (immediate and sustained release), oral solutions, and softgels.

Material Categories:

All Hazard Categories: Our analytical services are equipped to handle materials across many categories, ensuring comprehensive analytical testing for any substance.

DEA Category I-V: We provide meticulous analytical testing services for substances classified under DEA Categories I-V, adhering to the strictest regulatory standards.

Photosensitive Compounds: Our analytical services include specialized testing protocols for photosensitive compounds, protecting their integrity under various light conditions.

Moisture Sensitive Compounds: We offer analytical testing solutions for moisture sensitive compounds, ensuring their stability and quality in different environmental conditions.

Oxidation Sensitive Compounds: Our analytical services are designed to rigorously test oxidation sensitive compounds, preventing degradation and ensuring efficacy.

Analytical Method Development and Validation: Our analytical services are not just limited to testing; we also specialize in the development and validation of robust analytical methods.

Regulatory Compliance: With our analytical testing, we ensure that all products meet stringent regulatory standards, providing peace of mind and market readiness.

Environmental Testing: Our analytical services extend to environmental testing, helping you assess the impact of your products on the environment.

Data Integrity and Reporting: We uphold the highest standards of data integrity, with analytical testing results that are accurate, reproducible, and meticulously reported.

Single Point of Contact for All Phases: Renejix offers a dedicated point of contact to streamline analytical testing processes throughout all phases of drug development.

Assurances that Current Guidelines are Met: Our analytical services are aligned with current guidelines, ensuring compliance with ICH requirements and other regulatory standards.

Effective Communication: We prioritize clear and effective communication to facilitate analytical testing activities and project success.

Preclinical

Non-GMP: Renejix provides non-GMP analytical testing services for early-stage development, focusing on flexibility and innovation.

GLP: Our Good Laboratory Practice (GLP) analytical services ensure that preclinical data is reliable and regulatory compliant.

Preformulation and Solid State Characterization: Analytical testing at Renejix includes comprehensive preformulation studies and solid-state characterization to predict product performance.

Early Phase Clinical

Phase-Appropriate Validation: Our analytical services offer phase-appropriate validation, ensuring that methods are suitable for the stage of clinical development.

Assessment of Prototype Formulations: Renejix’s analytical testing capabilities include thorough assessment of prototype formulations to optimize drug delivery.

First-in-Man Studies: We provide analytical services that support first-in-man studies, focusing on safety and efficacy.

Clinical Trial Material: Analytical testing for clinical trial materials at Renejix is conducted with precision and care to support successful trials.

Late Phase Clinical / Pre-Commercial

Registration: Our analytical services play a crucial role in the registration process, providing the necessary testing to meet regulatory demands.

Design of Experiments/Quality by Design: Renejix employs analytical testing within design of experiments to ensure quality by design in drug development.

Process Validation: We offer analytical services that include process validation, confirming that production processes yield consistent and high-quality products.

Photostability: Analytical testing for photostability at Renejix ensures that products remain stable under light exposure.

Temperature Excursions/Shipping Studies: Our analytical services assess the impact of temperature excursions during shipping to guarantee product integrity.

Shelf-life, Expiry Dating: Renejix’s analytical testing determines shelf-life and expiry dating, critical for product safety and efficacy.

Packaging Component Assessment/Interactions: We provide analytical services to evaluate packaging components and their interactions with the drug product.

Commercial

Phase IV / Line Extension: Our analytical testing supports Phase IV studies and line extensions, ensuring ongoing product quality and monitoring.

Additional topics to consider:

Analytical Testing for Bioequivalence: Renejix offers analytical services to demonstrate bioequivalence, a key factor in generic drug approval.

Impurity Profiling and Identification: Our analytical testing includes impurity profiling, identifying and quantifying impurities for product quality.

Extractables and Leachables Studies: Renejix’s analytical services conduct studies on extractables and leachables to ensure product and packaging safety.

Assessment of Abuse-Deterrent Formulations: Our analytical services are critical in the assessment of abuse-deterrent formulations, ensuring they meet regulatory standards and protect patients.

Metals Testing: We provide comprehensive metals testing as part of our analytical testing suite, identifying and quantifying metal contaminants in products.

Dissolution Testing: Our analytical services include dissolution testing, which is essential for evaluating product performance and ensuring consistent drug release.

Litigation Testing: Renejix offers specialized analytical testing to support litigation cases, providing robust data and expert analysis.

Particle Size Distribution Analysis: Our analytical services utilize advanced technologies for particle size distribution analysis, a key factor in product quality and performance.

Extractables and Leachables Testing: We conduct thorough analytical testing for extractables and leachables, ensuring product and packaging safety.

Chemical Characterization: Our analytical services provide detailed chemical characterization to understand and improve product formulations.

Stability Testing: Renejix’s analytical testing includes stability studies to determine the shelf life and storage conditions of products.

Method Transfer and Optimization: We offer analytical services for method transfer and optimization, ensuring methods are robust across different laboratory settings.

Chromatography

  • High Performance Liquid Chromatography (HPLC): Our analytical services offer HPLC, a cornerstone of analytical testing, providing high-resolution results for complex mixtures.
  • Ultra High Performance Liquid Chromatography (UHPLC): With UHPLC, our analytical testing capabilities are enhanced, allowing for faster and more efficient separation of compounds.
  • Rapid Resolution Liquid Chromatography (RRLC): RRLC is part of our advanced analytical services, delivering rapid and high-resolution chromatographic testing.
  • Wide Range of HPLC Detectors: Our analytical testing utilizes a variety of HPLC detectors, including UV, PDA, Fluorescence, CAD, RI, and ELSD, to meet diverse analytical needs.
  • Gas Chromatography (GC): GC is a key component of our analytical services, ideal for the separation and analysis of volatile compounds.
  • Thin Layer Chromatography (TLC): TLC is included in our analytical testing services for quick screening and identification of compounds in a sample.
  • Capillary Electrophoresis (CE): Our analytical services use CE for the high-efficiency separation of molecules, based on their size-to-charge ratio.

CFR Part 11 Compliant Chromatography Data Acquisition System

Organic Spectroscopy:

  • Nuclear Magnetic Resonance Spectroscopy (NMR): Our NMR analytical services provide detailed molecular structure elucidation, which is essential for complex analytical testing scenarios.
  • Fourier Transform Infrared Spectrophotometry (FTIR): FTIR is a pivotal part of our analytical testing suite, offering rapid and reliable identification of organic and inorganic substances.
  • UV/VIS Spectrophotometry: Our analytical services include UV/VIS spectrophotometry, a fundamental technique for quantitative and qualitative analysis in various samples
    .
  • Polarimetry: As part of our analytical testing capabilities, polarimetry is utilized to determine the optical rotation and concentration of optically active substances.
  • Near Infrared (NIR): NIR analytical services are offered to provide non-destructive and rapid analysis of pharmaceutical and agricultural products.
  • Raman Spectroscopy: Our Raman spectroscopy analytical testing is ideal for characterizing chemical compositions and monitoring changes in material properties.
  • Mass Spectrometry: Mass spectrometry analytical services at our facility enable precise quantification and detection of compounds even at trace levels.
  • X-Ray Powder Diffraction: X-ray powder diffraction is included in our analytical testing to determine crystalline structures and analyze solid-state compounds.

Dissolution:

  • USP Apparatus 1, 2, 3, 4, 5, 6, 7: Our comprehensive dissolution analytical services utilize all USP Apparatus types to ensure versatile and accurate analytical testing for a variety of dosage forms.
  • F2 Testing: F2 testing is a key component of our analytical testing suite, providing critical comparative dissolution profiles for pharmaceutical products.
  • Biowaivers: Our analytical services support biowaiver applications by conducting rigorous dissolution testing to demonstrate bioequivalence without the need for in vivo studies.
  • Intrinsic Dissolution: We offer intrinsic dissolution analytical testing, an essential service for understanding the dissolution rate of pure pharmaceutical compounds.

Karl Fischer:

  • Volumetric Karl Fischer: Our volumetric Karl Fischer analytical services provide precise water content determination, a critical aspect of many analytical testing protocols.
  • Coulometric Karl Fischer: For low moisture content, our coulometric Karl Fischer analytical testing offers high sensitivity and accuracy.
  • Evaporative Karl Fischer: Our evaporative Karl Fischer analytical services are ideal for samples that are challenging to dissolve, ensuring comprehensive moisture analysis.

Physical Testing:

  • Hardness Testing: Our analytical services include hardness testing, which is a crucial part of the analytical testing process for evaluating tablet strength and durability.
  • Friability Testing: Friability testing is an essential analytical service that we provide to assess the physical integrity of tablets under stress.
  • Particulates (HIAC): High Accuracy Airborne Particle Counting (HIAC) is a key component of our analytical testing services, ensuring the safety and cleanliness of pharmaceutical products.
  • Osmolality/Osmolarity Testing: Our analytical services measure osmolality/osmolarity, providing valuable insights into the concentration of osmotically active particles in solutions.
  • Disintegration Testing: We offer disintegration testing as part of our analytical testing suite to evaluate the time it takes for tablets or capsules to break down in the body.
  • Viscometers: Our analytical services utilize viscometers to measure the viscosity of liquids, an important parameter in the quality control of liquid formulations.

Particle Analysis:

  • Malvern: Our Malvern analytical services provide advanced laser diffraction techniques for precise particle size analysis, a critical component of comprehensive analytical testing.
  • Microscopy: Microscopy is a fundamental part of our analytical testing capabilities, offering high-resolution imaging for detailed particle characterization.
  • Sieving: Sieving is included in our analytical services to determine particle size distribution, a vital test for quality control in manufacturing processes.
  • HIAC (High Accuracy Airborne Particle Counting): HIAC is a key analytical testing service we offer, ensuring accurate measurement of particulate contamination in samples.
  • Cascade Impaction: Our analytical services utilize cascade impaction for aerodynamic particle size distribution testing, essential for inhalation product development.

Thermal Analysis:

  • Differential Scanning Calorimetry (DSC): Our DSC analytical services provide crucial insights into the thermal properties of materials, a vital part of the analytical testing process for stability and compatibility studies.
  • Thermogravimetric Analysis (TGA): TGA is an essential analytical testing technique we offer, allowing for the precise measurement of weight changes in a material as a function of temperature.
  • Dynamic Vapor Desorption (DVS): Our DVS analytical services are key for understanding sorption properties of materials, providing valuable data for product performance and shelf life.

Metals Analysis:

  • Inductively Coupled Plasma Mass Spectrometry (ICP-MS): Our ICP-MS analytical services offer unmatched sensitivity and precision, making it a cornerstone of metals analytical testing for trace element detection.
  • Inductively Coupled Plasma Atomic Emission Spectrometry (ICP-AES/OES): ICP-AES/OES is integral to our analytical testing suite, providing rapid and accurate elemental analysis across a wide dynamic range.
  • Microwave Digestion: Microwave digestion is a preparatory step in our analytical services that enhances the efficiency and safety of sample preparation for subsequent metals analysis.
  • Graphite Furnace Atomic Absorption Spectrometry (GFAAS): GFAAS enhances our analytical testing capabilities with its high sensitivity for detecting trace metals in complex matrices.
  • Cold Vapor Atomic Absorption Spectrometry (CVAAS): Our CVAAS analytical services are specialized for mercury analysis, offering high sensitivity and selectivity in analytical testing.
  • Flame Atomic Absorption Spectrometry (FAAS): FAAS is a robust part of our analytical services, ideal for quantifying metals in various samples through analytical testing.

Microscopy:

  • Light Microscopy: Our light microscopy analytical services provide a fundamental approach to visualizing sample details, playing a crucial role in the initial stages of analytical testing.
  • Hot Stage/Optical Microscopy: Hot stage/optical microscopy is a specialized analytical testing service we offer, enabling the observation of samples under controlled heating conditions.
  • Cold Stage/Optical Microscopy: Our cold stage/optical microscopy analytical services allow for the examination of samples at low temperatures, essential for understanding material behavior in different thermal environments.

Microbiology:

  • Antimicrobial Efficacy: Our analytical services rigorously evaluate antimicrobial efficacy, ensuring that your products meet the required standards for inhibiting microbial growth.
  • Bioburden Testing: Bioburden analytical testing is a critical service we provide, quantifying the microbial load on pharmaceutical products before sterilization.
  • Container Closure Integrity Testing: Container closure integrity is an essential part of our analytical services, safeguarding against microbial contamination throughout a product’s shelf life.
  • Microbial Limits Testing (MLT): MLT is a fundamental analytical testing procedure we perform to determine acceptable levels of microbial contamination in non-sterile products.
  • Sterility Testing: Our sterility analytical testing ensures that sterile products are free of viable contaminating microorganisms, a crucial service for patient safety.
  • Microbial Identification: We offer microbial identification as part of our analytical services, utilizing advanced techniques to pinpoint the specific microorganisms present in samples.

Stability Storage & Testing:

  • Stability Storage: Our stability storage analytical services provide a controlled environment to assess how various storage conditions affect your product’s shelf life and efficacy.
  • Accelerated Stability Testing: As part of our analytical testing, we conduct accelerated stability studies to predict the long-term behavior of products under normal storage conditions.
  • Real-Time Stability Testing: Our real-time stability analytical services monitor products over their intended shelf life, ensuring they meet quality standards until expiry.
  • Photostability Testing: We include photostability testing in our analytical services to evaluate the effects of light exposure on product stability.
  • Temperature Cycling Studies: Our analytical testing includes temperature cycling to determine the impact of temperature fluctuations on product integrity.
  • Humidity Testing: Humidity control is a critical aspect of our analytical services, assessing the effect of moisture on product stability and packaging.
  • Freeze-Thaw Cycle Testing: We offer freeze-thaw cycle analytical testing to understand how freezing and thawing may affect product quality and efficacy.

TEST ACTIVE PHARMACEUTICAL PRODUCTS FASTER AND MORE EFFICIENTLY

Our comprehensive suite of services includes GMP/GLP-analytical microbiology services and specialty services. Our seasoned pharmaceutical team provides method development support, consulting, problem-solving expertise, and analytical flexibility. Opt for our routine analytical testing methods or tailor a program to your specific sampling and testing requirements.

COMPENDIAL TESTING

  • Compendial Testing: Our compendial analytical testing ensures that your products adhere to established pharmacopeia standards, providing reliable and consistent results.
  • Microbiology Testing: We offer microbiology analytical services to detect and quantify microbial presence, ensuring product safety and compliance.

DRUG SUBSTANCE / DRUG PRODUCT TESTING

  • Compendial Testing: Our analytical services include rigorous compendial testing to verify that drug substances and products meet all necessary pharmacopeial specifications.
  • Method Development / Validation / Transfer: We specialize in analytical testing method development, validation, and transfer, ensuring robust and accurate analytical procedures.
  • Structure Characterization: Our analytical services provide detailed structure characterization to elucidate the molecular composition of drug substances.
  • Release & Stability Testing: We conduct release and stability analytical testing to ensure that drug products maintain their integrity and efficacy throughout their shelf life.

MANUFACTURING SUPPORT TESTING

  • Excipient Compatibility: Our analytical testing evaluates excipient compatibility, crucial for the successful formulation of drug products.
  • In-Process Testing: We offer in-process analytical services to monitor and optimize manufacturing processes, ensuring product quality.
  • Blend/Content Uniformity: Our analytical testing includes blend and content uniformity assessments, essential for ensuring consistent drug distribution within a batch.
  • Feasibility/Prototype Stability: We provide feasibility and prototype stability analytical services to predict how formulations will perform during development.
  • Cleaning Verification/Validation: Our analytical testing encompasses cleaning verification and validation, confirming the absence of contaminants post-manufacturing.
  • Process Validation, DOE, QbD: We integrate analytical services into process validation, Design of Experiments (DOE), and Quality by Design (QbD) to enhance product development.
  • Container/Closure Evaluation: Our analytical testing includes container/closure evaluation to ensure the integrity and compatibility of packaging with drug products.
  • Packaging Component Screening: We conduct packaging component screening as part of our analytical services, assessing the suitability of packaging materials for drug products.

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FAQs

Here are some frequently asked questions about Analytical Services

What Analytical Services Do CDMOs Offer?

 CDMOs offer a wide range of analytical services to support pharmaceutical development and manufacturing. These services include but are not limited to method development and validation, stability testing, impurity profiling, dissolution testing, and raw material testing. Advanced analytical capabilities such as high-performance liquid chromatography (HPLC), gas chromatography (GC), mass spectrometry (MS), and nuclear magnetic resonance (NMR) spectroscopy are utilized to ensure precise and accurate analysis of pharmaceutical products.

Why Are Analytical Services Important in Pharmaceutical Development?

Analytical services are crucial in pharmaceutical development for ensuring the safety, efficacy, and quality of drug products. They provide essential data on the chemical composition, stability, and potency of pharmaceuticals, which is critical for regulatory submissions and compliance. Analytical testing helps in identifying and quantifying impurities, validating the manufacturing process, and ensuring that the final product meets the specifications and standards set by regulatory authorities.

What Is Method Development and Validation?

Method development and validation are processes used to ensure that an analytical method is suitable for its intended purpose. Method development involves designing a test that is accurate, precise, specific, and reproducible for analyzing a particular pharmaceutical product or component. Validation is the process of demonstrating that the method consistently produces reliable results within specified limits. It includes assessments of accuracy, precision, specificity, linearity, range, and robustness of the method.

How Is Stability Testing Conducted?

Stability testing is conducted to evaluate how the quality of a drug substance or drug product varies with time under the influence of environmental factors such as temperature, humidity, and light. The testing involves storing the product at specified conditions and testing it at predetermined intervals to assess physical, chemical, and microbiological stability. This testing is critical for determining shelf life, storage conditions, and packaging requirements.

Can CDMOs Provide Regulatory Compliance Support?

Yes, CDMOs can provide comprehensive regulatory compliance support as part of their analytical services. This includes generating data and documentation needed for regulatory submissions, such as Investigational New Drug (IND) applications, New Drug Applications (NDA), and Abbreviated New Drug Applications (ANDA). CDMOs stay updated on regulatory guidelines and requirements to ensure that analytical testing and documentation meet the standards of regulatory bodies like the FDA and EMA.

What Is Impurity Profiling?

Impurity profiling is the identification, quantification, and analysis of impurities in drug substances and products. It is crucial for ensuring the safety and efficacy of pharmaceuticals. Impurities can arise from various sources, including raw materials, synthesis processes, degradation, and interactions with packaging. CDMOs use sophisticated analytical techniques to detect and characterize these impurities, ensuring that they are within acceptable limits.

How Do CDMOs Ensure Data Integrity in Analytical Services?

CDMOs ensure data integrity by adhering to Good Laboratory Practices (GLP) and following strict standard operating procedures (SOPs) for all analytical testing. Data integrity measures include using validated analytical methods, calibrating instruments regularly, training personnel thoroughly, maintaining detailed records of all tests and results, and using secure data management systems. Regular audits and quality checks are performed to ensure compliance with data integrity principles.

Are CDMOs Equipped to Handle Highly Potent Compounds?

Yes, many CDMOs are equipped with specialized facilities and equipment to safely handle highly potent compounds. These include containment systems and dedicated labs designed to protect personnel and prevent cross-contamination. CDMOs have expertise in developing and validating analytical methods for highly potent compounds, ensuring accurate and safe handling throughout the analytical process.

Can CDMOs Support Formulation Development with Analytical Services?

Absolutely, CDMOs play a crucial role in supporting formulation development with their analytical services. They provide critical data on the compatibility of drug substances with excipients, the stability of formulations, and the optimization of formulation processes. Analytical services such as dissolution testing, content uniformity testing, and release rate profiling are integral to developing effective and stable pharmaceutical formulations.

How Do CDMOs Stay Ahead in Analytical Technologies?

CDMOs stay ahead in analytical technologies by continuously investing in the latest analytical instruments and software, training their personnel in cutting-edge methodologies, and staying abreast of scientific and regulatory developments. They collaborate with technology providers, participate in industry conferences, and contribute to research and development efforts. This commitment ensures they can offer advanced and efficient analytical services to meet the evolving needs of the pharmaceutical industry.