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Product Name: Citicoline Sodium Expiry Date: 2years |
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Item |
Requirements |
Results |
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Description |
A white or almost white crystalline Powder,odorless; |
Complies |
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Solubility |
Easily soluble in water,insoluble in ethanol and acetone |
Complies |
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Identification
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1. Chemical reaction,solution turns green 2. The retention time complies to the standard 3. Infrared absorption spectrum complies to the standard 4. Show sodium flame |
Positive reaction
Complies
Complies
Complies
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PH |
6.0-7.5 |
6.7 |
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Clarity,color |
Clear,colorless |
Complies |
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Related substances |
5’-CMP≤0.3% |
0.02% |
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Single impurity≤0.2% |
0.02% |
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Total impurity≤0.7% |
0.06% |
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Residual solvents |
Limit of methanol ≤0.3% |
Undetected |
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Limit of ethanol ≤0.5% |
Undetected |
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Limit of acetone ≤0.5% |
Undetected |
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Limit of chloride |
≤0.05% |
Complies |
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Limit of ammonium salt |
≤0.05% |
Complies |
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Limit of iron salt |
≤0.01% |
Complies |
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Limit of phosphate |
≤0.1% |
Complies |
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Limit of arsenic salt |
≤0.0001% |
Complies |
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Loss on drying |
≤6.0% |
0.9% |
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Heavy Metals |
≤5ppm |
Complies |
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Endotoxin |
≤0.3EU/mg |
Complies |
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Limit of microbe |
Total bacterial count ≤ 1000CFU/g Yeast & Mold≤ 100CFU/g E.Coli:Negative |
<15CFU/g <10CFU/g Undetected |
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Assay(HPLC) |
98.0% |
99.5% |
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Conclusion: Meets the requirements |
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