USP Testing. Every Batch. Every Time.

At QuVa Pharma, we do more than meet the required standards for sterility, endotoxin and potency testing—we take end product testing to the highest level by testing every single batch, every time. With a Certificate of Analysis including actual results for each batch to evidence testing, you can be sure our methods are validated. And because no product is released at risk, you’ll have peace of mind before springing into action.

 

STERILITY TESTING USP <71>

  • 14 Day Sterility Hold: Every batch tested for sterility and held for the duration of the test (minimum 14 days) prior to release.
  • Method Suitability: Every formulation undergoes method suitability testing using full USP panel of 6 organisms to ensure the methodology is valid.
  • Strict Sampling Guidelines Compliant with USP <71> requirement, the appropriate sample size is collected that is representative of the batch size.

 

ENDOTOXIN TESTING USP <85>

  • Batch Testing: Endotoxin testing is performed on every lot regardless
  • Endotoxin Limits: Established for every individual formulation based on the maximum dosage per hour, average patient weight and route of administration in accordance with USP <85>.
  • Endotoxin Method Validation: Performed on every formulation to ensure that interfering factors in the formulation do not inhibit the functionality of the test and cause false negatives and that the sensitivity of the test is maximized.

 

POTENCY (HPLC)

  • Batch Testing: Every batch is potency tested regardless
  • Potency Range: Potency tested prior to release and expected to meet the minimum USP potency range of 90-110% of the label.
  • Potency Testing Method: Performed using high performance liquid chromatographic analysis to ensure potency is accurate and precise.