Name of Product |
Vitamin B1 Hcl/Thiamine Hydrochloride |
|
Shelf Life |
3 years |
|
Test Items |
Specification |
Results of Analysis |
Appearance |
white or almost white crystalline powder or colourless crystals |
White cyrstalline powder |
Identification |
(1) should be positive reaction |
(1) positive reaction |
|
(2) Consistent with the reference IR spectra |
(2) Consistent with the reference IR spectra |
Appearance of solution | clear, not more intense than Y7 | clear, not more intense than Y7 |
Sulphates |
NMT300ppm | <300ppm |
Limit of nitrate |
No brown ring |
No brown ring |
Heavy Metals |
NMT 20ppm |
<20ppm |
Water | NMT 5.0% | 2.1% |
Residue on igonition | NMT 0.1% | 0.04% |
Absorbance of solution | NMT 0.025 | 0.025 |
Residual Solvents |
|
|
Methanol | NMT 0.3% | <0.3% |
Ethanol |
NMT 0.5% | <0.5% |
Related substances (Disregard limit 0.05%) |
|
|
Any impurity |
NMT 0.4% | 0.07% |
Total Impurities |
NMT 1.0% | 0.17% |
Conclusion |
This batch comlies with the specification of BP2015/USP38. |