* Introduction
HFM Analysis Center was jointly established with SiChuan University in 1996,mainly responsible for quality control of our trade products and the study related to COS/DMF dossiers, and provide services such as study of impurity profile, analysis of residue solvents, synthesize, separation and identification of reference standard and routine physical and chemical test.
HFM Analysis Center, covering an area of 100 square meter or so, owns a few HPLC(one is used for preparation), GC, Automatic Polarimeter and UV spectrophotometer etc. |
Over many years,HFM Analysis Center always execute according to GLP to ensure the scientific and traceable of the results
Under the guidance of the pharmaceutical professor with profuse experience in analyzing of remedy, HFM Analysis Center made much contribution on applying 10 COS Certificate by utilizing the advanced instruments and the advantage of situated in SiChuan University, in which there are complete large-scaled fine instruments and all kinds of subject implement each other.
*Serves
HFM Analysis Center provides three main serves: analyzing of remedy, study related with COS/DMF and chemical reference standard preparation.
1.Analyzing of remedy
Analyze remedy according to pharmaceutical specification or client’’’’’’’’’’’’’’’’s specification, include:
(1)Identification:Identify remedy with chemical method, UV method, IR method, and chromatographic method
(2)Test:Analyze chloride, sulfate, iron, ammonium, heavy metals, Arsenic, residue solvents, related substance (with method of HPLC, TLC, UV etc.)
(3)Assay:Analyze assay of remedy with volumetric analysis, UV Spectrophotometry, HPLC chromatographic, GC chromatographic etc.
2.Study related with COS/DMF to implement the necessary of enterprises for applying COS/DMF:
(1)on organic impurities
(2)on residual solvents
(3)on analysis of nucleic acids
(4)on analysis of proteins
3.Chemical reference standard preparation(synthesize and separation etc.)
*Research achievements
(1)Study on organic impurities in griseofulvin
(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 |
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Laboratory equipment |
Laboratory equipment |
Laboratory equipment | |
