Analytical/Stability/CMC Package Services

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Analytical/Stability/CMC Package Services

In order to properly manufacture drugs or biologically specific manufacturing processes, product characteristics and product testing must be determined to ensure that products are safe, effective and consistent between batches. These activities are known as CMC, chemistry, manufacturing and control. Analytical research and development has a support function in the areas of all other drug development including API analysis, drug product and special research activities.

Below is a list of our analytical/Stability/CMC package services (include but not limited to the following):

The development, validation and transfer of analytical methods are key elements of any drug development plan. Method Development/validation services are for residual solvents detection four individual APIs and pharmaceuticals, APIs and preservatives assays in drug products, and impurities in APIs and pharmaceuticals. These services also apply to material and/or test requirements not covered by the compendium specification.

We can provide comprehensive analytical testing and method development services. We provide best-in-class services for structure characterization, material characterization, element impurity analysis (based on ICH Q3D, USP<232>, and USP<233>), potentially genotoxic impurities, impurity separation and identification, DMPK analysis, method development and validation, raw material testing, API and drug release testing and stability test.

Drug stability research is an important part of drug product development and life cycle, especially to support development and IND/NDA submission activities. They allow the stability of the active drug component (API) or the stability of the drug product to be evaluated under the influence of various environmental factors such as temperature, humidity and light. Data from these studies enable the recommended storage conditions, retest intervals, and shelf life to be determined.

The separation process is a method of converting a mixture or solution of a chemical into a mixture of two or more different products. At least one of the separation results is enriched in one or more components of the source mixture. In some cases, separation may completely decompose the mixture into pure components. Separation utilizes differences in chemical or physical properties (such as size, shape, mass, density, or chemical affinity) between components of a mixture. The large scale separation services of BOC Sciences can be achieved by quick turnaround time, competitive cost, and outstanding capacity of approaching batch products.

When applying for approval of new drugs, all regulators require information related to product manufacturing and testing. For FDA, this is reflected in the Chemical, Manufacturing, and Control Guide. CMC information is required when submitting IND, NDA, AND, and annual reports. The content required depends on the type of substance or product.

With the increasing demand for chemical and biotechnology products for the treatment of various diseases, the safety and quality of these products have attracted the attention of many patients and manufacturers. Therefore,it is important of isolation, identification and characterization of a broad range of chemical compounds and large molecules.

With validated, controlled and monitored technique platforms and experienced staff, BOC Sciences can offer a full package of analytical/stability/CMC services that satisfy the ICH guidelines for the assessment of your drug products. Glad to hear your comments and look forward to cooperating with you!

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