Pharmaceutical OTC

Pharmaceutical OTC

We provide analytical testing services for the Personal Care, Pharmaceutical and Nutraceutical industries.

Some of our most highly qualified technicians can be found in our chemistry department.

We offer world-class equipment, and testing expertise at affordable prices.

With Micro Quality Labs you get a testing partner that you can trust to help you navigate through the maze of testing requirements needed to get your product safely to the market.

*Our testing methods conform to ISO 9001 and cGMP or GLP Standards

  • Preservative Effectiveness Testing USP <51>
  • Active Assay per USP guidelines
  • Microbial Assay USP <61and 62>
  • Stability ICH guidelines
  • Bulk and Finished Product Release Testing
  • Water - USP 3474 (0.45 micro filter testing)
  • Detection of Coliform
  • Total Coliform
  • Fecal Coliform
  • Escherichia coli
  • Pseudomonas

*And Other Actives as Requested

General Physical tests

  • Raw material testing per monographs
  • Impurity Analysis
  • General Analytical Tests

Stability Tests

  • Container Integrity Studies
  • Potency Assays
  • Sterilization and Package Validation
  • Dissolution Testing

Stability Studies-(See Stability Tab)

Micro Quality Labs has state of the art stability chambers of various sizes with multiple temperature and humidity conditions required to meet FDA and ICH requirements.

  • Accelerated Study
  • Long Term Stability
  • Drug Product Stability
  • Stability Storage

Heavy Metals Testing, USP

  • Elemental Impurities-Limits, USP
  • Elemental Impurities-Procedures, USP
  • Residual Solvents, USP

Water Testing

  • Total Organic Compound Determination
  • Conductivity Measurement, USP

 

 

 

 



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