The safety tests of the preparations mainly include bacterial endotoxin test, pyrogen test, abnormal toxicity test, allergic reactive substance test, antihypertensive substance test, hemolysis test and coagulation test.

Drug quality research services based on in vitro permeation test (IVPT) and in vitro release test (IVRT) are provided for transdermal and topical drug delivery systems, which also contains description, identification, pH, viscosity, particle size, rheology, crystal form, prescription analysis and microbial related tests. IVPT studies characterize the rate and extent of a drug from a topical or transdermal product available at or near a site of action in the skin to afford the permeation profile of a drug into and through the excised animal skin.

Reverse engineering research is the key indexes such as the content of raw and auxiliary materials and preparation technology, which are deduced by the reverse analysis of the original drug. Most generic drugs include the active ingredient API and excipients (APIs are pharmacologically active, pharmacodynamic ingredients; Excipients do not have clinical efficacy, but to some extent, it may affect the quality, safety and efficacy of drugs. The physicochemical properties (molecular level study) of the functional excipients and APIs in generic drugs are one of the important steps in reverse engineering and even play a decisive role in the success of generic drugs.

Sterilizing filtration validation is the process of removing all microorganisms, excluding viruses, from a fluid stream. A sterilizing filter must remove all microorganisms present in a fluid stream without adversely affecting product quality. The sterilization filter needs to pass the challenge test of 1×107cfu/cm2 microbial load to evaluate its retention capacity, and the filter integrity needs to be evaluated after the challenge test.

Package integrity, also known as container-closure integrity, is the ability of a package to prevent product loss, to block microorganism ingress, and to limit entry of detrimental gases or other substances, thus ensuring that the product meets all necessary safety and quality standards. Our integrity service platform is the first comprehensive innovation research platform established in China. With the most advanced detection technology, top scientific research team and rich domestic and international application experiences, we provide integrated services including positive control preparation, methodology development and validation (on-line and off-line), sample detection, integrity assessment, etc. as well as online guidance, technical training and other technical output services. Our services run through all phases of the product life cycle (packaging selection, process validation, commercial manufacturing and stability study) ensuring that the product meets all necessary safety and quality standards.

Interactions between a material and the pharmaceutical product it contacts are well documented. These interactions involve the transfer of substances between the material and the pharmaceutical product and include sorption (binding), the transfer of product components (such as the active ingredient) into the material, or leaching, the transfer of material components (such as plastic additives) into the pharmaceutical product. Compatibility research is a process of establishing extractable and leachable profiles and gathering sorption information to perform scientific assessment on the risk of drug quality and safety.

We have the leading technical level in the field of compatibility research and have assisted our customers to obtain more than 100 drug production licenses and IND licenses.

The compatibility research involves packaging systems (vials, ampoules, prefilled syringes, cartridges, etc.), manufacturing systems (silicone tube, stainless steel tank for liquid preparations and storage bag for bio-products) and delivery systems (disposable syringes, infusion sets, atomizers, etc.).