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英文名：Orlistat（Tetrahydrolipstatin）
化學名：(S)-2-甲酰氨-4-甲基-戊酸(S)-1-[[(2S,3S)-3-己基-4-氧-氧雜環(huán)丁基]甲基]-十二烷基酯
CAS No：96829-58-2
分子式：C29H53NO5
分子量：495.75
性狀：白色至類白色結晶性粉末，易溶于甲醇、乙醇、丙酮和乙醚，幾乎不溶于水
熔點：42～45℃
有機雜質：
Related substances Ⅰ:
a. Orlistat related compound A ≤ 0.2%
Related substances Ⅱ
a. Orlistat related compound B ≤ 0.05%
Related substances Ⅲ
a. Formylleucine ≤0.2%
b. Orlistat related compound C ≤ 0.05%
c. Orlistat open ring epimer ≤ 0.2%
d. D-Leucine orlistat ≤ 0.2%
e. Individual unidentified impurity ≤ 0.1%
Related substances Ⅳ
a. Orlistat related compound D ≤ 0.2%
b. Orlistat open ring amide ≤ 0.1%
Related substances Ⅴ
a. Orlistat related compound E ≤ 0.2%
Total impurities (Ⅰ-Ⅴ) ≤ 1.0%
Residual solvents: Methanol: ≤0.3%
EtOAc: ≤0.5%
n-Heptane: ≤0.5%
無機雜質：
Residue on ignition: ≤0.1%
Heavy metals : ≤20ppm
總雜質：≤2.0%；
含量：≥98% -101.5%by HPLC
包裝規(guī)格：藥用鋁瓶1kg、5kg、10kg
批準文號：國藥準字H20120050
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