Items | Specification |
Content | 73.0% to 79.0% of riboflavin (C17H20N406; Mr 376.4) (dried substance) |
Appearance | Yellow or orange-yellow, crystalline, hygroscopic powder |
Solubility | Soluble in water, very slightly soluble in ethanol (96%) |
Identification | Be positive |
PH | 5.0~6.5 |
Specific Optical Rotation | +38.0° to+ 43.0°(dried substance) |
Impurity E | The filtrate is not more intensely coloured than reference solution BY6 |
Related Substances | Impurity D≤6.0% |
Impurity F≤0.7% |
Impurity G≤0.6% |
Impurity H≤0.4% |
Unspecified impurities: for each impurity≤0.2% |
Total≤8.0%; |
Composition | Riboflavin 5#39;-(sodium hydrogen phosphate) hydrate≥65.0% |
Riboflavin4#39;-(sodium hydrogen phosphate) hydrate≤12.0% |
Riboflavin 3#39;-(sodium hydrogen phosphate) hydrate≤7.0% |
Riboflavin 3#39;5#39;-bis(sodium hydrogen phosphate) hydrate≤3.5% |
Riboflavin 4#39;,5 #39;-bis(sodium hydrogen phosphate) hydrate≤3.5% |
Riboflavin 3#39;,4#39;-bis(sodium hydrogen phosphate) hydrate≤1.0% |
Inorganic Phosphate | ≤1.0% |
Loss on drying | ≤8.0% |
Heavy Metal | ≤10mg/kg |
Residual Solvents | Ethanol≤0.5% |
Acetonitrile≤0.041% |
Pyridine ≤0.02% |
Microorganism Limits | Aerobe bacteria≤800cfu/g |
Moulds and yeasts≤80cfu/g |
E.coli: ND |
Standard | EP 11.2 |