產(chǎn)品名稱

Product Name

Raloxifene HCl

CAS

82640-04-8

批號(hào)

Batch No.

22050901

生產(chǎn)日期

Producing Date

2022-05-09

數(shù)量

Quantity

50kg

復(fù)測(cè)期

Retest Date

2024-05-08

項(xiàng)目

Items

標(biāo)準(zhǔn)

Standard

結(jié)論

Results

外觀

Appearance

類白色或淺黃色粉末

Almost white or pale-yellowish powder

符合

Comply

鑒別

Identification

IR

符合

Comply

氯化物

It meets the requirements of the test for Choride

符合

Comply

溶解性

Solubility

溶于10%的氫氧化鈉溶液，略溶于甲醇，不溶于水

Soluble in 10% sodium hydroxide solution, slightly soluble in methanol, insoluble in water

符合

Comply

有關(guān)物質(zhì)

Related Substances

有關(guān)物質(zhì)I≤0.2%

ImpurityⅠ≤0.20%

≤0.2%

0.18%

其它單個(gè)雜質(zhì)

 Other single impurity

≤0.1%

0.06%

總雜質(zhì)

Total impurities

≤0.5%

0.38%

干燥失重

Loss on drying

≤0.5%

0.20%

灼燒殘?jiān)?/strong>

≤0.1%

0.04%

重金屬

Heavy metals

≤10ppm

符合

Comply

有機(jī)殘留

Residual  solvents

甲醇≤ 3000ppm

符合

Comply

二氯甲烷≤600ppm

符合

Comply

含量

Assay

97.5%～102.0%

99.2%

結(jié)論

Determination

符合USP40標(biāo)準(zhǔn)

Complies with USP40 standard