質(zhì)檢報(bào)告單——CERTIFICATE OF ANALYSIS

產(chǎn)品名稱

羅紅霉素

產(chǎn)品批號(hào)

20230909

Product Name

Roxithromycin

Batch No.

批次數(shù)量

1321.2KG

生產(chǎn)日期

2023-09-14

Quantity

Man. Date

包裝規(guī)格

25KG/紙桶/Drum

檢測(cè)日期

2023-09-24

Packaging

Test Date

有效日期

2025-09-13

報(bào)告日期

2023-09-27

Expiry Date

Report Date

檢驗(yàn)項(xiàng)目

檢驗(yàn)指標(biāo)

檢驗(yàn)結(jié)果

Test Items

Standard

Test Results

外觀

白色或類白色結(jié)晶性粉末

符合規(guī)定

Appearance

White or off-white crystalline powder

Complies

溶解性

符合規(guī)定

符合規(guī)定

Solubility

Complies

Complies

鑒別

符合規(guī)定

符合規(guī)定

Identification

Complies

Complies

溶液外觀

澄清無(wú)色

符合規(guī)定

Solution of appearance

Clear and colourless

Complies

比旋度

-93° ~ -96°

-94°

Specific rotation

雜質(zhì) A Impurity A≤0.5%

0.14%

雜質(zhì) B Impurity B≤0.5%

ND

雜質(zhì) C Impurity C≤0.5%

0.15%

雜質(zhì) D Impurity D≤0.5%

0.079%

有關(guān)物質(zhì)  HPLC

雜質(zhì) E Impurity E≤0.5%

ND

雜質(zhì) F Impurity F≤0.5%

0.17%

Related substances

雜質(zhì) G Impurity G≤1.0%

0.088%

雜質(zhì) H Impurity H≤0.5%

0.095%

雜質(zhì) I Impurity I≤0.5%

0.36%

雜質(zhì) J Impurity J≤0.5%

0.11%

總雜質(zhì) Total impurities≤3.0%

1.4%

甲醇 Methanol≤3000ppm

222ppm

丙酮 Acetone≤5000ppm

21ppm

殘留溶劑

Thiethy lamine≤320ppm

ND

Residual solvent

二氯甲烷 Methylene chloride≤600ppm

ND

N,N-二甲基甲酰胺 N,N-Dimethylformamide≤880ppm

ND

醋酸 Acetic Acid≤5000ppm

54ppm

水分

≤3.0%

2.1%

Water

硫酸灰分

≤0.1%

0.06%

Sulphated ash

含量（無(wú)水物）

96.0~102%

97.5%

Assay（Anhydrous）

結(jié)論

本品符合 EP10.0 質(zhì)量標(biāo)準(zhǔn)

Conclusion

Complies with EP10.0 standard

Tester(化驗(yàn))：Zhangmin

Re-tester(復(fù)核)：Wanghong

Director(主管)：Liliang