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Items of Analysis | Standard of Analysis | Test Results |
Appearance | Dark red crystals or dark red crystalline powder | Conform |
Identification A | UV:Absorption maxima at 278±1nm,361±1nm and 550±2nm. | Conform |
A361nm/A278nm: 1.70~1.90 A361nm/A550nm: 3.15~3.45 |
1.86 3.26 |
|
Identification B | TLC:The principal spot in the chromatogram obtained with the test solution is similar in position, colour and size to the principal spot in the chromatogram obtained with the reference solution. | Conform |
Loss on drying | ≤10% | 3.1% |
Assay | 97-102% | 99.3% |
Related substances | Total impurities ≤3% | 1.3% |
Acetone | ≤5000 ppm | 619 ppm |
The total aerobic microbial count | ≤1000 cfu/g | 65 cfu/g |
The total combined yeasts/mould count | ≤100 cfu/g | <10 cfu/g |
Conclusion | Conforms to Factory Standard |
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