Lab & Analytics

Quality Matters.

Testing and Analytical Services is one of Axcentria’s differentiating factors.  We offer fully integrated analytical services that include method development, method validation and testing using the latest analytical technologies. 

Axcentria has a staff of quality and formulation scientists and technicians with extensive pharmaceutical training.  We are uniquely qualified to develop and validate the analytical methodology to test your products for appearance, physical properties, potency of ingredients, and impurities. Our Laboratory can provide method development and method validation protocols to support ANDA, NDA, and INDs in compliance with current FDA and ICH Guidances.

Method Development Services:

  • Identification
  • Assay testing
  • Impurity determination
  • Stability indicating methods
  • Moisture
  • pH
  • Total Organic Carbon
  • Oxidative and reductive stress
  • Light stressing
  • Microbial testing

Method Validation Services:

  • Accuracy
  • Precision Repeatability
  • Intermediate precision
  • Reproducibility
  • Specificity
  • Detection limit
  • Quantitation limit
  • Linearity
  • Range
  • Robustness
  • System Suitability Testing

Our analytical laboratories follow current Good Manufacturing Practices (cGMP) and have efficient and flexible quality systems in place to align with our project management, formulation development and manufacturing operations.

The Axcentria Standard:

  1. Inspection and testing of incoming materials to the US Pharmacopeia standards
  2. Proprietary High Pressure Liquid Chromatography method to ascertain product purity and adherence to label claims
  3. Microbiological tested to insure products are within pre-established FDA contamination limits
  4. Testing for stability over time

Microbiological tests are also a required step in our Purity Pledge protocol to ensure that our quality control of the product is maintained throughout the manufacturing and packaging processes without any microbial cross contamination. The FDA has pre-established total microbial contamination limits and identification of specific organisms to reduce consumer risk.

Axcentria offers ICH  (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) stability storage, testing requirements and customized storage conditions. Our stability chambers have monitoring with redundant systems, backup power and comprehensive disaster recovery plans.

We can provide test reports or Certificates of Analysis as needed - view PDF Certificate of Analysis here. Axcentria Pharmaceuticals provides and documents expiration dates and lot coding to all its products according to current FDA regulations.

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