Customization: | Available |
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Powder: | Yes |
Customized: | Non-Customized |
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Test Items | Specification |
Appearance | White crystalline or crystalline powder, odorless |
Solubility | Freely soluble in water, insoluble in ethanol, in acetone and in chloroform |
Identification | Comply with the standard |
PH | 6.0-7.5 |
Clarity and color of solution | Should be clear and colorless |
Chlorides | ≤0.05% |
Ammonium salt | ≤0.05% |
Iron | ≤0.01% |
Phosphates | ≤0.1% |
Loss on drying | ≤6.0% |
Heavy metals | ≤0.0005% |
Arsenic | ≤0.0001% |
Bacterial endotoxins | <0.3EU/mg |
Microbial contamination | Total bacterial count≤1000cfu/g |
Yeast & molds≤100cfu/g | |
E.coli: not detected | |
Related substances | 5'-CMP≤0.3% |
Other signle 1 impurities≤0.2% | |
Other total impurities≤0.7% | |
Residual solvent | Methanol≤0.3% |
Ethanol≤0.5% | |
Acetone≤0.5% | |
Assay | NLT 98.0% Citicoline sodium, calculated on the anhydrous basis |