Items of Test | Limits of Test |
1.Appearance | Orange yellow crystalline powder |
2.Identification | Positive |
3.Acidity or Alkalinity | check the color of the test solution after adding the respective solutions |
4.Lumiflavin | Absorbance of the filtrate at 440nm does not exceed 0.025 (USP);not more intense than BY6(BP) |
5.Absorbance | 0.31-0.33 A373nm/A267nm 0.36-0.39 A444nm/A267nm |
6.Particla Size | 100% passes through 60 mesh sieve |
7.Specific Rotation | between-115o and -135o (BP/USP) |
8.Loss on Drying | ≤1.5% |
9.Heavy Metals | <10ppm |
10.Residue on Ignition | ≤0.3% (USP) ≤0.1%(BP) |
11.Organic Volatile Impurities | Method IV <467> (USP) |
12.Assay(ondried basis) | 98.0%-102.0% (USP) 97.0%-103.0% (BP) |