Analytical Chemists Solving Tough Problems!

Product Testing & Development Specialists

Call us at: 1-800-930-5450

Analytical Method Development and Validation

Our analytical method development team can produce accurate and reliable methods that deliver consistent results.  From measuring the concentration of an active pharmaceutical ingredient (API) in a specific compounded dosage form to identifying and quantifying the excipients, intermediates, raw materials, preservatives, antioxidants, impurities and more within a formulation, we can ensure that your product maintains the proper identity, purity, potency, and performance.

Beyond just method development our skilled method validation chemists can verify existing methods to help ensure approval of regulatory submissions.  Our team can also improve upon existing methods by identifying gaps and proposing a detailed remediation plan.  This can even include tailoring existing test methods to your drug substance or drug product, which can save on both times and costs in developing an analytical method.  We can even take on difficult LC-MS method validations and complex ELISA assays.  Our experienced staff can develop methods for even the most complex formulations within your timeframe.  We develop custom proposals to complete the analyses you require when certifying a new drug product or amending a current drug application.

If you have a method development or validation project that cannot be done in-house due to its complexity, or you need the work performed in a faster time period than your in-house laboratory can handle, Avomeen can help.  As development partners, we can design detailed protocols for method development, validation, and technology transfer based on the product’s phase in the drug development process.

What Necessitates the Development of Analytical Methods During Drug Development?

  • Lack of methods in any pharmacopoeias for a specific drug or drug combination
  • Existing procedures require expensive reagents or solvents, require highly complex extraction or derivatization procedures, or may not be reliable

 
Analytical Method Development & Validation for Raw Materials & Finished Products Including:

  • Pharmaceuticals, Nutraceuticals & Biopharmaceuticals
  • Immediate & Modified Release Formulations
  • Polymers & Coatings
  • Small & Large Molecules

 
Capable Support of Multiple Dosage Forms:

  • Injectables (Lyo & Non-Lyo)
  • Solids, Semi-Solids & Liquids
  • Inhalation/Nasal
  • Transdermal & Suppository

 
Our scientists develop custom CDER/ICH and FDA Method Development & Validation protocols based on established guidelines.  All methods are tested under strict internal and external requirements, we can develop methods for:

  • Custom Assay Development
  • Potency & Purity Methods
  • Complex Method Validation
    • Accuracy & Recovery
    • Precision (Test/Re-Test Reliability & Intermediate Precision)
    • Specificity & Selectivity
    • Limit of Detection (LOD)
    • Limit of Quantitation (LOQ)
    • Linearity & Range
    • Samples Stability in Matrix
    • Stock Solutions Stability
    • Homogeneity
    • Ruggedness
    • Robustness

 
Method Development & Validation Studies For:

• Characterization of Drug Substances • Pharmacokinetic, Bioavailability & Bioequivalence • Method Transfer & Training
• Analytical Standard Characterization • Release Testing & Evaluation • Formulation Development
• Reference Standard Qualification • Drug Excipient Compatibility Studies • Product Deformulation
• Active Assay & Related Substances • IND Phase-Appropriate Method Validation • Comparative Studies
• Gap Analysis & Remedial Validation • Process Impurity • Vendor Qualification
• Extractables & Leachables • Chromatographic & Chiral Purity • USP Method Testing
• Solubility & Solution Stability Studies • Residual Solvents Analysis • ELISA Assay
• Stability Indicating Assays • Peak Identification • Column Equivalency Studies
• Prototype Evaluation – Accelerated/Stress Studies • Cleaning Procedures Validation • Technical Consulting
• Forced Degradation Studies • Cleaning Residual Assays • Counterfeit Product Evaluation
• Dissolution Testing • Process Validation & Remediation Support • Material Contact Studies
• Preservative Assays • Physical Methods • Method Life-Cycle Evaluation Studies
• Preservative & Stabilizing Excipients Assays • Nasal Spray Characterization

  
Contact Avomeen to Arrange a Free Initial Consultation With One of Our Ph.D. Chemists
Call: 800-930-5450
Email: scientist@avomeen.com

Problem Solving
Avomeen scientists utilize the latest techniques, instrumentation, and methods to analyze a wide variety of complex testing challenges.
Customer Service
Our whole team is committed to completing each customer's project to their exact specifications, including custom methods and rush services.
Instrumentation
Avomeen's investigations include the use of FT-IR, GC/MS, LC/MS, HPLC, NMR, SEM/EDXA, ICP, AA, TGA, DSC, and many other techniques.
Contact Us
Avomeen Analytical Services
4840 Venture Drive
Ann Arbor, MI 48108
Phone: 1-800-930-5450
Fax: 1-800-930-5479
Email: scientist@avomeen.com