Pharmaceutical Analytical Service at Alfa Chemistry Testing Lab Fuels Drug R&D

Alfa Chemistry has a cGMP-compliant laboratory that can provide high-quality pharmaceutical analytical services at every stage of drug development. With constantly updated analytical methods and equipment and also the ability to adapt to changing regulations and ongoing needs, the lab helps customers to specify and solve the difficulties and problems that may exist in drug R&D so as to achieve the final success.

Effectiveness and safety are the top concerns in developing pharmaceutical products. During the research and production process, lots of factors are playing a role in deciding the final results, for example, the physical and chemical properties, the impurities introduced in the production process, and even the storage container of the pharmaceutical.

“Having realized the significance of pharmaceutical analytical testing, some pharmaceutical companies come to us and seek for customized pharmaceutical analytical services including Biopharmaceutical Characterization, Preformulation Analysis, Separation and Purification Service, Impurity Testing Services, Stability Analysis, Failure Analysis and Deformulation (Reverse Engineering),” says the Marketing Chief of Alfa Chemistry Testing Lab.

Separation and Purification

Regulatory agencies such as FDA usually require that all impurities present in >0.1% w/w should be separated and quantitated. Separation is essential during the various steps of drug development and manufacturing. Chirality/Enantiomeric forms of a drug can show different potencies, physicochemical properties, and behavior in biological systems. A suitable chirality or enantiomeric form is critical to obtain an ideal performance of drug formulations.

Impurity Testing

Impurities in the drug, which may come from raw materials, pollutants, reagents catalysts, solvents and intermediates, are the main factors that affect the purity of the drug. Excessive impurities may change the physical and chemical constants and affect the stability of the drug. In the worst situations, the increased impurities may cause the drug content to be less active. Therefore, the detection of impurities in drugs is a very important part of controlling the quality of drugs. Alfa Chemistry offers sensitive detection methods to make a determination of the levels of pharmaceutical impurities, which are required for completing relevant risk assessments and supporting submission requirements.

Biopharmaceutical Characterization

Small variations of biologic molecules may lead to a strong impact on the final biological properties and treatment efficacy. Therefore, adequate characterization of biopharmaceuticals is essential for candidate products to be developed and approved for marketing. Biopharmaceutical characterization is carried out to ensure the safety, efficacy, quality, purity and potency of biopharmaceutical products.

Deformulation Analysis (Reverse Engineering)

Deformulation research is a complex process that requires the analysis of primary and secondary components using a variety of analytical instruments, analytical techniques, and extraction methods. Alfa Chemistry's experts have extensive experience in deformulation analysis of pharmaceutical and medical devices.

To learn more about Alfa Chemistry Testing Lab’s pharmaceutical analytical capabilities, please visit https://www.alfachemic.com/testinglab/. 

About Alfa Chemistry Testing Lab

As always, Alfa Chemistry Testing Lab is committed to helping customers worldwide solve problems in analytical testing. Through years of experience, this lab has grown to be a well-established brand in the industry. Owing to its advanced instruments such as chromatography (HPLC, GC, GC/MS) and atomic absorption spectroscopy (AAS, GFA, FIAS), the lab has received worldwide recognition from its clients in various analytical testing services. Overall the task of Alfa Chemistry Testing Lab is to reduce product quality risks, protect health and safety, enhance market advantage, and transfer trust value.