產(chǎn)品名稱(chēng)

Name

噻托溴銨

Tiotropium Bromide monohydrate

CAS

411207-31-3

產(chǎn)品批號(hào)

Batch No.

20221218

批數(shù)量

Batch Size

258.8g

生產(chǎn)日期

Mfg.Date

2022.12.18

有效期至

EXP.Date

2024.12

檢驗(yàn)日期

Test Date

2022.12.20

報(bào)告日期

Report Date

2022.12.30

檢驗(yàn)依據(jù)

Specification

EP9.4

檢驗(yàn)項(xiàng)目及結(jié)果

TEST and results

檢驗(yàn)項(xiàng)目

Test

標(biāo)準(zhǔn)

Acceptance Criteria

檢驗(yàn)結(jié)果

Results

外觀(guān)

Appearance

白色或黃白色粉末或結(jié)晶

White or yellowish-white powder or crystals

白色結(jié)晶

White crystals

溶解度

Solubility

略溶于水，溶于甲醇，幾乎不溶于二氯甲烷

Sparingly soluble in water,soluble in methanol,practically insoluble in methylene chloride.

符合規(guī)定

complies

鑒別

Identification

紅外光吸收?qǐng)D譜應(yīng)與對(duì)照品的圖譜一致

Infrared absorption spectrophotometry comparison Tiotropium Bromide monohydrate CRS

符合規(guī)定

complies

本品的水溶液顯溴化物的鑒別反應(yīng)

It gives reaction of bromides

呈正反應(yīng)

Positive reaction

雜質(zhì)G和雜質(zhì)H

Impurities G and H

雜質(zhì)G≤0.1%；雜質(zhì)H≤0.1%

Impurity G≤0.1%，Impurity H≤0.1%

未檢出

Not detected

有關(guān)物質(zhì)

Related substances

單雜：≤0.10%；總雜：≤0.2%

Unspecified impurities:≤0.10%,Total impurities:≤0.2%

未檢出

Not detected

水分

Water

2.5%~4.0%

3.4%

硫酸灰分

Sulfated ash

不得過(guò)0.1%

NMT 0.1%

＜0.1%

含量

Assay

按無(wú)水物計(jì)算，含C19H22BrNO4S2 98.5~101.5%

98.5%~101.5%(anhydros substance)

99.4%

結(jié)論

Conclusion

本品按EP檢驗(yàn)，結(jié)果符合規(guī)定。

The test results comply with EP9.4.