Compendial Testing

Compendial testing is a critical part of quality assurance and compliance in the pharmaceutical and biotech industry. It involves conducting a series of tests on raw materials and finished products according to the specifications and procedures outlined in the pharmacopeia or compendia. It can ensure the conformance of raw materials and finished products with established specifications for identification, strength, quality and purity, and it provides assurance that the manufacturing process remains consistent. In a word, compendial testing ensures the safety, potency, quality, and efficacy of pharmaceutical products before they are distributed in the market. For any drug sponsor or applicant, they must assess their drug substances and products in accordance with the standards outlined in official compendia. Alfa Chemistry offers comprehensive compendial testing service towards a wide range of raw material and final product that align with international regulatory authorities. Our team has extensive experience in conducting a wide array of tests using the latest analytical techniques and methodologies that aims to assist you in upholding these standards and ensuring the utmost safety and effectiveness of your products.

Alfa Chemistry's compendial testing services include:

• Raw Materials Testing: Raw materials analysis mainly involves identity testing, impurity profiling, and quantification of active components. This can ensure that raw materials meet respective compendial monographs and maintain the essential quality for the production of the final drug product. The test objects of raw materials include active pharmaceutical ingredients (APIs), excipients, and packaging materials. For the latter two, the specific materials are as shown in the following table:

• Drug Products Testing: Compendial testing for drug products encompasses a wide range of tests specific to the dosage form. These tests include identity, assay, dissolution, content uniformity, residual solvents, and microbial testing. This can help in confirming the quality, safety, and efficacy of drug products.

Most commonly referenced compendia at Alfa Chemistry

Our testing services adhere to the requirements outlined in the most commonly referenced compendia, including:

Alfa Chemistry also conducts tests according to standards from AOAC, AOCS, Standard Methods, TAPPI, EPA, and ASTM, as well as our clients' defined specifications.