品    名

Product Name

非那雄胺（Finasteride）

規(guī)    格

Specification

1 kg/Tin

批    號(hào)

Batch No

20190528

數(shù)    量

Quantity

1kg

生產(chǎn)日期

MFG. Date

2019.05.28

檢驗(yàn)標(biāo)準(zhǔn)

Test Standard

According to USP37

有效日期

Exp Date

2021.05.28

檢驗(yàn)項(xiàng)目

Test Items

檢驗(yàn)指標(biāo)

Specification

檢驗(yàn)結(jié)果

Test Results

性狀

Description

白色或類白色結(jié)晶性粉末

White or off-white crystalline powder

類白色結(jié)晶性粉末

Off-white crystalline powder

比旋度

Specific rotation

-56°~-60°

-58.2°

鑒別

Identification

IR

Matches with working standard

Complies

HPLC

溶解性

Solubility

Freely soluble in chloroform and in alcohol; Very slightly soluble in water

Conform

重金屬

Heavy metals

≤10ppm

＜10ppm

水分

Water

≤0.3%

0.22%

灼燒殘?jiān)?/p>

Residue on ignition

≤0.1%

0.05%

相關(guān)物質(zhì)

Relative material

最大雜質(zhì)≤0.5%

0.36%

總雜質(zhì)≤1.0%

0.52%

含量Assay

98.5~101.0%

99.48%

結(jié)論

Conclusion

符合USP37

Passed