Analytical Testing for Non-Sterile Products

As a global, integrated CDMO, our in-house analytical testing capabilities complement our development and manufacturing services to provide a true end-to-end solution from development to commercialization.

Analytical testing is a critical component of pharmaceutical product manufacturing as it involves evaluating the quality, purity, potency, and safety of drug products to ensure that manufactured drug products meet the required specifications and comply with regulatory standards.

Release testing encompasses multiple tests to assess purity, concentration, identity and safety of the product and is essential to maintain consistent product quality; ensuring drug products meet the desired standards. It involves the analysis of multiple parameters, including the identification and quantification of active pharmaceutical ingredients (APIs), assay and impurities, content uniformity, dissolution and microbial testing.

Batch release testing involves a comprehensive analysis of the final product batch to ensure it meets the predefined quality standards. It includes various tests such as visual inspection, assay of APIs, testing for impurities, dissolution testing, and stability testing to ensure that every batch of drug product is of the required quality and meets the specifications before it reaches the market.

Microbiological testing is performed to evaluate the presence of microorganisms in pharmaceutical drug products and are crucial to ensure that products are free from harmful bacteria, fungi, and other microorganisms that could pose a risk to patient safety.

Our dedicated team of specialists will be happy to discuss any of our Analytical Testing Services with you. Contact us on +1 779-208-1819 (US) or +44 1495 711 222 (UK/EU) or email talkfuture@pci.com