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Analytical Method Development Services

Accurate and Reliable Analytical Method Development and Validation

Analytical method development, validation, and transfer are integral to pharmaceutical drug development programs. Analytical methods must be suitable for their intended purpose and must also meet accuracy, reproducibility, and reliability standards. GMP analytical methods can be developed to establish the identity, purity, physical characteristics, and potency of an active pharmaceutical ingredient (API) in a specific compounded dosage form, as well as identify and quantify the excipients, intermediates, raw materials, preservatives, antioxidants, impurities, and more. According to the International Conference on Harmonisation (ICH) per the ICH-Q2(R1) guidance, the most common types of analytical procedures are identification tests, quantitative tests for active ingredient and impurities, and limit tests for the control of impurities in samples of API, drug product, or other selected component(s) in the drug product.

Any analytical methods that are used to analyze drug products or substances for regulatory submissions must undergo validation, as required by regulatory agencies at various stages of the drug development and approval process. In fact, method validation is a requirement for any methods developed for pharmaceutical products regulated by current Good Manufacturing Practices (GMP). Methods must undergo rigorous validation to establish accuracy, precision, linearity, specificity, selectivity, limits of detection and quantitation, and robustness. Additionally, test methods developed for stability evaluation of products must be stability-indicating, demonstrated through forced degradation studies. In summary, analytical methods must be validated to establish consistent scientific soundness of the method in order to ensure drug development success and ultimately maintain patient safety.

Avomeen’s regulatory and industry experts provide CDER/ICH and FDA method development and validation services based on established guidelines and have a proven track record of success developing accurate and reliable methods for highly complex formulations and sample matrices, including validation of compendial procedures per USP <1225> Validation of Compendial Methods.

GMP Analytical Method Verification & Transfer

Not all analytical methods must be fully validated prior to use. Compendial and monograph methods found in pharmacopeias “have been validated in accordance with accepted scientific practice and current recommendations of analytical validation. Unless otherwise stated in the monograph or general chapter, validation of the test methods by the analyst is not required.”

While compendial and monograph methods do not need full validation, they must still undergo verification to assess selected analytical performance characteristics, such as those detailed USP <1226> Verification of Compendial Procedures. This verification confirms that the method is suitable for its intended purpose, including the specific drug product, substance matrix, and use conditions.

Additionally, existing analytical methods can be transferred to Avomeen’s laboratory for direct testing use and/or optimization. Similar, Avomeen can easily handle the transfer of developed to client production sites. Our scientists can even provide training to the team at the receiving site to make sure the method transfer meets regulatory requirements, as detailed in USP <1224> Transfer of Analytical Procedures. Whether your product requires comparative testing or inter-laboratory method validation, we have the resources to ensure your method transfer goes smoothly.

Avomeen offers:

Proven success developing, validating, and transferring sophisticated, complex, and challenging analytical methods Flexible and customized solutions to meet your specific needs throughout the drug development lifecycle, including phase-appropriate development and validation Consultative scientists well-versed regulatory guidance with decades of experience working with a variety of sample matrices

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Fit For Purpose Method Development and Validation Services

As development partners, we can design detailed protocols for method development, validation, and technology transfer based on specific phases in the drug development lifecycle. Avomeen’s methods are developed and validated using a “fit for purpose” approach, and are appropriate for specific drug development phases (Table 1).

Analytical Method Development Services:

Sample Matrices Experience:

  • Tablets
  • Capsules
  • Suspensions
  • Injectables
  • Suppositories
  • Powders and granules
  • Syrups
  • Inhalants
  • Oral and topical liquids
  • Creams, ointments and gels
  • Oligonucleotides and biologics
  • Combination products

 

Analytical Method Development and Validation Services Considerations, Fit For Purpose Analytical Method Development and Validation Considerations

Table 1: Analytical Method Development and Validation Services Considerations

Advanced Instrumentation

Chromatography Systems:

  • Agilent HPLC
  • Agilent HPLC with DAD and Thermo-ESA Corona Charged Aerosol Detector
  • Agilent HPLC with DAD and Polymer Labs PL/ELS ELSD
  • UPLC with DAD & Fraction Collector
  • Agilent GC-FID/TCD
  • Agilent GC-MS/FID with Headspace Autosampler
  • Ion Chromatography System
  • Dionex Integrion RFIC System
  • Waters Acquity UPLC with Xevo G2-S Quadrupole Time of Flight (QTOF)

Mass Spectrometers:

  • Thermo Finnigan LCQ Deca LC-MS
  • Sciex HPLC + API LC-MS/MS
  • Maldi Micro MX Mass Spectrometer
  • Agilent Inductively Coupled Plasma Mass Spectrometer
  • Agilent ICP-MS
  • AB Sciex Triple Quadrupole API Mass Spectrometers

Other Capital Instrumentation:

  • Evolution Dissolution Apparatus Systems
  • Protein Simple Maurice Capillary Electrophoresis (CE)
  • Perkin Elmer Spectrum FT-IR
  • ci4200 Spectrophotometer/ Colorimeter
  • BioTek Epoch Microplate Reader
  • Invitrogen Countess II Automated Cell Counter
  • NANODROP UV-Vis Spectrophotometer
  • Advanced® Micro-Osmometer
  • Karl Fischer Titrators
  • TA Instruments Differential Scanning Calorimetry
  • TA Instruments TGA
  • Sievers Laboratory TOC Analyzer
  • Brookhaven ZetaPALS Zetasizer
  • Malvern Mastersizer
  • Franz Vertical Diffusion Cells Apparatus
  • Caron Stability Chambers (Custom Settings)

 

Your Partner for Pharmaceutical Method Development and Validation

Robust, transferrable, and reproducible methods generate the high-quality results needed to support regulatory filings. Our consultative analytical method development services team has the expertise and knowledge to take on highly complex compounds and drug products and deliver high-quality, validated methods. Get in touch with an expert to explore a partnership with Avomeen.

Let’s work together to achieve your vision

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