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Mannitol
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CERTIFICATE OF ANALYSIS
Commodity | Mannitol | Batch NO | 1309196 |
Packing | 25kg / bag | MFG. date | Sep.19.2013 |
Quantity | 5550kg | Expiry date | Sep.18.2015 |
Basis | Correspond to USP30 | ||
ITEM | STANDARD | RESULT | CONCLUSION |
Appearance | White crystalline powder | White crystalline powder |
Conformity |
Assay | 96.0% ~ 101.5% | 99.6% | Conformity |
Identification: Infrared absorption spectrophotometry | Conformity |
Conformity |
Conformity |
Melting point | 164℃~169℃ | 165.7℃~167.4℃ | Conformity |
Specific optical rotation | +137°~ +145° |
+139.8° |
Conformity |
Acidity (0.02mol/L NaOH) | Conformity | Conformity | Conformity |
Loss on drying | ≤0.3% | 0.2% | Conformity |
Chloride | ≤0.007% | 〈0.007% | Conformity |
Sulphate | ≤0.01% | 〈0.01% | Conformity |
Arsenic | ≤1ppm | 〈1ppm | Conformity |
Reducing sugars | Conformity | Conformity | Conformity |
Residual solvents | The raw materials, manufacturing process and product do not contain any of the solvents listed in Residual Solvents(USP<467>) | ||
Remark | |||
Conclusion | Conformity |
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