羟乙基淀粉130Hydroxyethyl Starch130 0.4

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 Starch130/0.4 Batch No. 20111206 Expiry date 2013.12 Report Date 2011.12.14 Quantity 1000kg Inspection Items Accepted Standard Results Appearance White or off white powder Off white powder Solubility Free soluble in water and in dimethyl sulfoxide,practically insoluble in anhydrous enhanlo. Complies Optical rotation ﹢182.0°～﹢192.0° ﹢188.5° clarity and color of solution λ400nm absorbance <0.025 Turbidity not deeper than reference suspension II Complies Identification (1) IR Complies (2) To complies positive reaction Complies pH 4.5-7.0 6.16 Intrinsic viscosity [η] 13.0-17.0 15.1 Heavy metals Not more than 10ppm Complies Loss on drying Not more than 6% 4.5％ Sodium chloride(NaCl) Not more than 0.1％ 0.030％ MS 0.38-0.45 0.42 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 110000-150000 136800 weight-average molecular weight（90％department） Not more than 400000 269690 weight-average molecular weight（10％department） Not less than15000 46289 Bacterial endotoxins Less than 2.5EU/g Complies Microbial limit Must complies Complies Assay(on dry base ,deducts the sodium chloride） Not less than 98.0％ 99.8％ Conclusion ：Complies with EP7.0 Analyst :shilijuan hecker:wuaho Supervisor :maohongjun