Impurity research is a very important part of drug quality study. When studying the structure of unknown organic impurities, it is often necessary to enrich and analyze the impurities by liquid phase preparation.
WEIPU YIYAO ensures that we provide professional service experience for customers with experienced impurity study team, professional separation and purification personnel, project leaders, excellent project management team. WEIPU YIYAO can provide the whole process service from separation and purification , structure identification, structure confirmation to method development and validation for impurities.

Impurity structure identification is a very important step in the process of impurity study. WEIPU YIYAO has a perfect instrument platform: for purified impurities, complete instrument characterization can be carried out, experienced technical team specializes in the identification of impurity structure; for non-purified impurities, WEIPU YIYAO can provide compound preparation services, or use other trace substances qualitative and quantitative methods to assist in the completion of the dentification of impurity structure. We have spared no effort to  solve the problem of unknown impurities for pharmaceutical enterprises.

In the registration of medicines, The "characteristics" study in the application documents requires confirmation of the structure of API and possible impurities. The enterprise needs to provide study data and spectrums, and conduct analysis and confirmation.

Sufficient structural confirmation requires not only the application of multiple types of analytical instruments, but also technicians with extensive application and analytical experience. In addition, as the registration data, organization's data integrity review requirements are also increasing.

WEIPU YIYAO can provide structural confirmation for multi-category drugs in one-stop service, and greatly improve the efficiency of drug registration with a complete instrument platform (such as FTIR, UV-VIS, NMR, MS, XRD, TGA, DSC, ORD, organic element analyzer, etc.), a technical team with more than five years of structural analysis experience, and the strict quality system guarantee.
Up to now, WEIPU YIYAO has helped over 100 pharmaceutical enterprises in China to complete structural confirmation for more than 500 compounds. 

Consistency evaluation of generic drugs requires enterprises to invest a lot of manpower and material resources, among which the formula and process study is the foundation. The rapid progress of formula study is closely related to the confirmation of granularity of raw materials, crystal form of raw materials, process route and excipient specifications.

WEIPU YIYAO can help enterprises to complete the characterization of RLD (Reference Listed Drug), such as API (active ingredients of drugs) crystalline form research, granularity research, ingredient proportion determination of formula , and judgment of preparation process, by virtue of years of reverse analysis and preparation research experience, which can help enterprises to finish the formula and process study faster and with higher quality. The Reverse Engineering will help enterprises to get twice the result with half the effort in consistency evaluation of generic drugs.

WEIPU YIYAO Testing Center is a platform specializing in providing testing services for pharmaceutical enterprises. We are supported by experienced R&D testing team, powerful instrument platform with NMR, field emission SEM-EDS, LC-TOFMS, ICP-MS, ICP-OES, TGA, DSC and other hundreds of testing instruments. Always Customer-centered, WEIPU YIYAO Testing Center brings customers fast, stable, accurate and warm services.