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產品檢驗報告單
CERTIFICATE OF ANALYSIS
品名:色甘酸鈉 Name:Sodium Cromoglicate |
生產日期:20230718 Mfg.date |
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批號:20230706 Batch No: |
報告日期:20230727 Report date: |
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檢驗依據:USP40 Inspection basis: |
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項目 Items |
標準 Specifications |
結果 Results |
|
性狀 Appearance |
White slightly wettable crystalline powder,odorless |
White slightly wettable crystalline powder,odorless |
|
溶解性 Solubility |
Soluble in water;insoluble in alcohol and in chloroform. |
complies |
|
鑒別 Identification |
A、B In pass |
complies |
|
酸堿度 pH |
In pass |
complies |
|
相關物質 Related Substance |
≤0.5% |
complies |
|
草酸鹽 Limit of Oxalaet |
In pass |
complies |
|
水分 Water |
≤10.0% |
3.42% |
|
殘留溶媒 Residual Solvents |
Ethanol≤0.5% |
Not detected |
|
重金屬 Heavy metals |
≤0.002% |
complies |
|
含量 Assay |
98.0%-101.0% |
99.7% |
|
有效期 Expiry date |
202606 |
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結論 conclusion |
Pass USP40 |