產(chǎn)品名稱PRODUCT NAME：環(huán)孢素CYCLOSPORINE A

產(chǎn)品批號BATCH NO.

202210910

生產(chǎn)日期MFG. DATE

2022.09.10

數(shù)量QUANTITY

250G

有效期EXP  DATE

2025.09.09

檢驗(yàn)項(xiàng)目

Inspection Item

標(biāo)準(zhǔn)規(guī)定

Specification

檢驗(yàn)結(jié)果

Results

鑒別Identification

高效液相色譜（HPLC）

應(yīng)符合規(guī)定Conform the requirement

Conform

檢查Test

有關(guān)物質(zhì)Related substances

單個(gè)雜質(zhì)

Individual impurity

≤0.7%

0.35%

雜質(zhì)總和

Total impurity

≤1.5%

0.96%

干燥失重Loss on drying

≤2.0%

0.87%

含量測定Assay

98.5—101.5%

98.6%

微生物限度

Microbial limit

需氧菌總數(shù)≤1000cfu/g

Total aerobic bacteria NMT 1000cfu/g

10cfu/g

霉菌和酵母菌總數(shù)≤100cfu/g

Total yeast and mold NMT 100cfu/g

5cfu/g

結(jié)論：此產(chǎn)品符合美國藥典42標(biāo)準(zhǔn).

Conclusion : THE PRODUCT CONFORM TO USP42.