Alfa Chemistry Testing Lab: Pharmaceutical Impurity Testing Services to Assist Drug Development

To help scientists and researchers specify and solve problems related to impurities, the New York-based analytical company Alfa Chemistry Testing Lab launched to provide a series of pharmaceutical impurity testing services, for purposes of making the drugs being developed comply with regulatory requirements and at the same time providing safe and effective commodities for consumers.

Impurities in drug substance can come from nearly all stages of drug development, for instance, in the synthetic/manufacturing processes. Storage container, excipients and many others can be sources of impurities as well. In other words, the emergence of impurities is almost unavoidable. To ensure that impurities do not affect the efficacy of drugs, they should be controlled within a level. However, study of impurities in pharmaceuticals is one of the most time-consuming and challenging tasks, so choose a third-party organization to conduct impurity testing would be a wise choice.

“Excessive impurities may change the physical and chemical constants and affect the stability of the drug, and even cause the drug to ineffective in the worst situation,” says the Marketing Chief of Alfa Chemistry Testing Lab. “Hence, the detection of impurities in drugs conceived as a very important part of controlling the quality of drugs. Impurities are of all kinds and can be volatile or nonvolatile, organic or inorganic. Our lab offers sensitive detection methods to make a determination of the constituents and levels of pharmaceutical impurities, which are required for completing relevant risk assessments and supporting submission requirements.” 

The pharmaceutical impurity testing services available at Alfa Chemistry Testing Lab include:

• Biopharmacuetical Process-related Impurities Analysis
• Organic Impurities Analysis
• Solvent Residual Analysis
• Elemental Impurities Analysis
• Genotoxic Impurities Analysis
• Extractables and Leachables

Different testing methods and instruments are used in the detection of different types of impurities. For Volatile impurities, HS-GC AND GC-MS are employed. For organic imputies, RP-HPLC, HPCE, HPTLC, HPGPC and Color Control are used. And for inorganic impurities, ICP-MS and Ion chromatography are chosen. To learn more about Alfa Chemistry Testing Lab’s pharmaceutical impurity testing services, please visit https://www.alfachemic.com/testinglab/services/pharmaceutical-products-performance-and-impurity-testing.html.

About Alfa Chemistry Testing Lab

Missioned to provide testing services as efficiently as possible so as to maximize customers' profits, Alfa Chemistry Testing Lab has made great endeavors in the past year, playing an active role in analytical testing. Thanks to the support of customers, the lab has grown to be a well-established brand recognized by many clients. With strong expertise and advanced testing equipment, the lab is a preferred choice for many analytical testing services.