| Function: | Antineoplastic |
|---|---|
| Grade Standard: | Medicine Grade |
| Type: | Chemical Reagent |
| State: | Powder |
| Volatile: | Not Volatile |
| Standard: | Ep |
| Samples: |
|---|
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Audited Supplier | Items | Standard |
| Appearance | Almost white to yellow crystalline powder |
| Identification | (A):The infrared absorption spectrum of the sample must be concordant with that of the reference substance |
| (B):Meets the requirements of the tests for Water | |
| (C):It gives reaction (a)of chlorides | |
| Appearance of solution | Clarity of solution:The solution is clear |
| Colour of solution:Not more intensely coloured than reference solution GY2 | |
| Enantiomeric Purity/Impurity L(HPLC) | Maximum 0.15 per cent |
| Related substances(HPLC) | Impurity E:Maximum 0.15 per cent |
| Unspecified impurities:Maximum 0.10 per cent | |
| Total impurities:Maximum 0.5 per cent | |
| Residual Solvents(GC) | Acetone:Not more than 5000 ppm |
| Methanol:Not more than 3000 ppm | |
| Dichloromethane:Not more than 600 ppm | |
| Water | Between 7.0% and 9.0% |
| Sulfated ash | Maximum 0.1 per cent |
| Microbial Limits | Total aerobic microbial count:Not exceed 100 cfu/g |
| Total combines molds and yeasts count:Not exceed 50 cfu/g | |
| Bacterial endotoxins | Less than 0.29 IU/mg irinotecan |
| Assay(HPLC) | Contains NLT 98.0% and NMT 102.0% of Irinotecan Hydrochloride(C33H38N4O6·HCl),calculated on the anhydrous basis |
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