羟乙基淀粉200 Hydroxyethyl Starch 200 0.5

Jinan Hongfangde Pharmatech Co., Ltd. Tel:86-531-55501998 Fax:86-531-88873618 hongfuda@gmail.com www.hfdchem.com ----------------------------------------------------------------------------------------------------------------------- CERTIFICATE OF ANALYSIS Product name Hydroxyethyl Starch200/0.5 Batch No. 20110916 Expiry date 2013.09 Report Date 2011.09.24 Quantity 1000kg Inspection Items Accepted Standard Results Appearance White or off white powder Off white powder Optical rotation ﹢182.0°～﹢192.0° ﹢186.0° clarity and color of solution λ400nm absorbance <0.025 turbidity not deeper than reference suspension II Complies Identification (1)To complies positive reaction Complies (2)IR Complies pH 4.5-6.5 6.24 Intrinsic viscosity [η] 15.0-19.0 17.5 Heavy metals Not more than 10ppm Complies Loss on drying Not more than 6.0% 3.8％ Sodium chloride(NaCl) Not more than 0.1％ 0.032％ MS 0.43-0.55 0.49 Glycol Not more than 40ppm Complies Chlorethyl alcohol Not more than 5ppm Complies Ethylene Oxide Not more than 1ppm Not detected weight-average molecular weight 180000-290000 213350 weight-average molecular weight（90％department） Not more than780000 477000 weight-average molecular weight（10％department） Not less than15000 44069 Bacterial endotoxins Less than 2.5EU/g Complies Microbial limit Must complies Complies Assay(on dry base ,deducts the sodium chloride） 98.0％～101.5％ 100.1％ Conclusion ：Complies with EP7.0 Analyst :shilijuan Checker:wuaho Supervisor :maohongjun