當(dāng)前頁面： 首頁 > 新聞中心新聞中心
Certificate of Analysis
|
產(chǎn)品名稱 Name |
噻托溴銨 Tiotropium Bromide monohydrate |
CAS |
411207-31-3 |
|
產(chǎn)品批號 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 |
報告日期 Report Date |
2022.12.30 |
|
檢驗(yàn)依據(jù) Specification |
EP9.4 |
||
|
檢驗(yàn)項目及結(jié)果 TEST and results |
|||
|
檢驗(yàn)項目 Test |
標(biāo)準(zhǔn) Acceptance Criteria |
檢驗(yàn)結(jié)果 Results |
|
|
外觀 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 |
紅外光吸收圖譜應(yīng)與對照品的圖譜一致 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0.1% NMT 0.1% |
＜0.1% |
|
|
含量 Assay |
按無水物計算，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. |
||
