文档介绍：枸椽酸他莫昔芬原料USP32标准（英文翻译）
枸椽酸他莫昔芬原料USP32标准
Tamoxifen Citrate
C26H29NO-C6H8O7
Ethanamine, 2-[4-(l/2-diphenyl-l-butenyl)phenoxy]-N/N-dimethyl, (Z)-,
2-hydroxy-l,2,3-propanetricarboxylate (1:1).
(Z)--二***2[4-(1,2-二苯基-1-丁烯基)苯氧基卜乙***枸椽酸盐
(Z)-2-[p-(l,2-Diphenyl-l-butenyl)phenoxy]-N,N-dimethylethylamine citrate (1:1)
[54965-24-1],
? Tamoxifen Citrate contains not less than percent and not more than percent of C26H29NO-C6H8O7, calculated on the dried basis.
枸椽酸他莫昔芬 按干燥品计算，含C26H29N0・C6H8O7不得少于
%,不得多于 %。
Packaging and storage一 Preserve in well-closed, light-resistant
、耐光的容器中保存。
Description: White, fine, crystalline powder. Soluble in methanol; very slightly soluble in water, in acetone, in chloroform, and in alcohol.
性状：本品为白色结晶性粉末。
本品在甲醇中溶解，在水、***、三***甲烷和乙醇中极微溶解。Melting
Point: Melts at about 142° , with decomposition.
熔点：本品的熔点大约为142 °C,熔融时同时分解。
USP Reference standards
USP Tamoxifen Citrate RS
Identification—
鉴别一
A: Infrared Absorption <197K>: a single band in the 1700 to 1740 cm-1 region of the spectrum.
红外吸收&t;197K&gt；：显示1700 -1740 cm-1区域的单波段。
B: Ultraviolet Absorption <197U>—
紫外吸收：
Solution: 20 |ig per mL.
溶液：每毫升20微克。
Medium: methanol.
介质：甲醇
Loss on drying <731>一 Dry it at 105°C for 4 hours: it loses not more than % of its weight.
干燥失重<731&gt；—取本品，置105°C干燥4小时，减失重量不得
过 %。 Residue on