Fujian Fukang Pharmaceutical Co. Ltd.

Related substances in 7-Aminocephalosporanic Acid (7-ACA) were detected and identified by High Performance liquid Chromatog.-Tandem Mass Spectrometry.The structures of the related substances in 7-Aminocephalosporanic Acid (7-ACA) were first studied by High Performance Liquid Chromatog.-Tandem Mass Spectrometry.Seven related substances in 7-Aminocephalosporanic Acid (7-ACA) were observedBased on the MS spectrometric data, the structures of the related substances were elucidated as deacetyl-7-aminocephalosporanic acid (D-7-ACA), deacetoxy-7-aminocephalosporanic acid (DO-7-ACA), cephalosporin (CPC), deacetyl 7-aminocephalosporanic acid lactone (D-7-AC A lactone), dehydroxy derivative of deacetyl CPC, open-loop derivative of CPC and CPC-Na.

There were considerable advantages in testing gentamicin sulfate on composition and impurities with HPLC-pulse electrochem. detector (PED) method.Besides direct injection, high sensitivity and good resolution, derivation reactions would be avoided.Within the testing range in this experiment, a good linearity was shown along with correlation coefficient exceeding 0.99.In addition, relative standard deviations of both repeatability and robustness in composition test were less than 2%, while that in impurities test was less than 10%, and the detection limit of composition C_2a was as low as 0.002 mg/mL.As could be seen from the testing results, for testing gentamicin sulfate on composition and impurities, HPLC-PED anal. method was convenient and accurate.

Controlling the rational and stable speed of feed liquid and steam is the basic principle in the process of continuous sterilization, so it is an absolute necessary to improve the process control system.Through the improvement on control system of current technol., i.e. setting up an automatic pressure control site on the spray cooling unit, thereby the stability of continuous sterilization temperature and hold time in the process pipe was guaranteed.And the probability of bacterial pollution was reduced, and the potency of zymotic fluid was increased.