Test Items | Standards | Results | |
Appearance | White or almost white crystalline powder or small granule | complies | |
Identification | B: IR absorption; D: Reaction (a) of chlorides | complies | |
Optical rotation | +83 °-+93° | +90.5 ° | |
Loss on drying | Max: 8% | 5.21% | |
Particle size | 90 % Through No 80 | complies | |
Heavy Metal | ≤10ppm | complies | |
Assay | 97.5%-100.5% | 99.5% | |
Conclusion | Conform to USP35 |