HFM Analysis Center was jointly established with West China School of Pharmarcy Sichuan University in 1996, mainly undertakes responsible for quality control of our trade products and the study related to COS/DMF dossiers, and provides services such as study of impurity profile, analysis of residue solvents, and routine physical and chemical test.
HFM Analysis Center, covering an area of nearly 100 square meter, owns a few HPLC (one is used for preparation), GC, Automatic polarimeter and UV spectrophotometer etc.
Over many years, HFM Analysis Center always executes GLP standards to ensure the scientificity and traceability of the results.
Headed by the pharmaceutical professor with profuse experience in pharmaceutical analysis, HFM Analysis Center made much contribution to successfully applying for 10 COS Certificates by utilizing the advanced instruments and the advantage of situated in Sichuan University, in which there are complete large-scaled precise instruments and multidisciplinary cooperation.
1. drug inspection, that is to inspect drugs according to the quality standards of Pharmacopoeias or clients’ standards, include:
(1) Identification: Identify drugs with chemical method, UV method, IR method, and chromatographic method
(2) Test: Test impurities in drugs such as chloride, sulfate, iron, ammonium, heavy metals, Arsenic, residue solvents, related substance (with method of HPLC, TLC, UV etc.).
(3) Assay: Determine the contents of drugs with volumetric method, UV method, HPLC method, GC method etc.
2. Studies related to COS/DMF, that is to conduct the necessary experiments to apply for COS/DMF to enterprises, include:
(1) on organic impurities
(2) on residual solvents
(3) on analysis of nucleic acids residual
(4) on analysis of proteins residual
3. Other physical and chemical test, such as physical and chemical inspection of plant extracts and chemical products.
(2)Study on organic impurities in progesterone
(3)Study on organic impurities in aspartic acid
(4)Study on organic impurities in vitamin B12
(5)Analysis of nucleic acids and proteins in vitamin B12
(6)Study on organic impurities in amoxicillin trihydrate
(7)Study on organic impurities in ranitidine hydrochloride
(8)Study on organic impurities in florfenicol
(9)Analysis of nucleic acids and proteins in tetracycline hydrochloride