Analysis items | Specification | Result | |
Items | BP2013 | USP36 | Colorless clear liquid |
Appearance |
White or almost white, crystalline powder or colorless crystals |
White or almost white, Crystalline powder or Colorless crystals |
Almost white crystalline powder |
Identification |
IR,Characteristic Reaction and Test of chlorides |
IR and Test of chlorides | Conform |
Assay,% | 98.5~101.0% | 98.0~102.0% | 99.7% |
pH | 2.7- 3.3 | 2.7- 3.4 | 3.0 |
Absorbance of solution | ---------- | ≦0.025 | 0.013 |
Solubility |
Freely Soluble in Water, Soluble in Glycerol, Slightly Soluble in Alcohol |
---------- |
Freely Soluble in Water,Soluble in Glycerol,Slightly Soluble in Alcohol |
Appearance of solution | Clear and not more than Y7 | ---------- | Clear and not more than Y7 |
Sulphates,ppm | ≦300ppm | ---------- | <300ppm |
Limit of nitrate | ---------- |
No brown ring is produced |
No brown ring is produced |
Heavy metals,ppm | ≦20ppm | ---------- | <20ppm |
Analysis items | Specification | Result | ||
Items | BP2013 | USP36 | Colorless clear liquid | |
Related substances |
Any Impurity,% |
≦0.4% | ---------- | 0.1% |
Total,% | ≦1.0% | ---------- | 0.2% | |
Water,% | ≦5.0% | ≦5.0% | 3.6% | |
Sulphated ash/ Residue on ignition,% |
≦0.1% | ≦0.2% | 0.04% | |
Chromatographic purity,% | ---------- | ≦1.0% | 0.1% | |
Conclusion | This batch of Vitamin B1 HCl meets the requirements of BP2013/USP36 |