Product Quality Research

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Product Quality Research

BOC Sciences' quality research team is familiar with various ICH and CFDA regulations and guidelines. Using our extensive technical research experience, we can provide quality research and stability research for various dosages and forms of pharmaceutical products. We can fully support the customer's API and formulation quality research needs. Our reliable data have helped many customers complete their pharmaceutical quality studies.

The development of pharmaceutical products is always challenged by a series of quality problems such as degradation-related impurities, undesirable disintegration and dissolution, and microbes induced unsafety. We can develop and deliver testing and analytical solutions to efficiently help solving the problems during your drug development process. More importantly, we have employed a team of highly qualified and experienced technicians to ensure high quality services for your quality research of pharmaceutical products.

Quality Research of the Products

Related Substances Test

The related substances are impurities in the pharmaceutical products. These may be raw materials, intermediates, reagents, decompositions, by-products, polymers, and isomers brought into the synthesis of APIs, Impurities could also be the degradation products produced in the process of storage, transportation and use. Because of the small content, it is important to choose the detection method with characteristics such as strong specificity, high sensitivity and good reproducibility.

BOC Sciences is experienced in toxicological risk assessments and analysis of residual solvents, process impurities, extractables & leachables, and other impurities. Offering a highly sensitive and specific method development, we bring high quality and safety to your pharmaceutical products.

Comprehensive evaluation of the tablet or capsule disintegration and dissolution profiles leads to a reliable understanding of the breakage and dispersion mechanisms that govern release rate of API, which can be used to predict the in vivo drug release profiles and finally support formulation development. Additionally, quantifying the disintegration and dissolution behavior in situ and in real time can also help to analysis and identify the root cause of inconsistencies during release testing. With a team of well-trained pharmaceutical experts, BOC Sciences is able to develop a suite of approaches for in situ particle characterization and help to monitor continuously during the disintegration and dissolution of tablets or capsules. By full range analysis of the kinetics and mechanisms, our experts work with clients to optimize their drug product formulation and process parameters in a more cost-effective way.

Moisture content plays a significant role in controlling the quality, safety, shelf life and other key properties of drug substance or pharmaceutical product. However, there are many kinds of components contained in the pharmaceutical products that have a high hygroscopicity. In this case, moisture analysis is an essential process during the manufacture of solid dosage forms. BOC Sciences is capable of offering a fast and accurate testing of moisture with a variety of techniques, such as Loss on Drying (LOD), Karl Fischer Titration, Capacitance, Radio Frequency, Near Infrared (NIR), Water Activity and others.

Microbiological test represents the procedure of identifying microbes or microorganisms in a pharmaceutical product to evaluate the quality of a drug formulation. The microbes contained in pharmaceuticals poses a great risk of drug product contamination, which may result in poor quality and unsafety for patients. Based on such consideration, the microbiological test is necessary during drug development and the microbes should be controlled at a certain level as required by many regulations. To ensure your project’s success, experts from BOC Sciences can provide customers with a full range of microbiology testing services that covers many aspects such as specific pathogens, bacteria, yeast, fungi, parasites, algae, viruses, and certain enzymes.

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Quality Research of the Products

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