GMP certificate
Items |
Standard |
Results |
Appearance |
A Yellow crystalline powder |
Conforms |
Melting point |
124--128°C |
125.9--126.6°C |
Identification |
?direct reaction ‚There is maximize absorption in 237nm wavelength ƒinfrared light of absorption atlas and Contrastion atlas consistency.(Spectrum section 599 plans set) |
direct reaction Conform
Conform |
Appearance of solution |
Solution S is clear |
Conform |
Optical rotation |
The angle of optical rotation,determined on solution S is-0.10º to +0.10º |
Conform |
Loss on drying |
≤0.5% |
0.21% |
residue |
≤0.1% |
0.03% |
Related substances A peak Single peak Sum of peak (apart from the principal peak) |
≤0.1% ≤0.2% ≤0.5% |
Conform Conform Conform |
Content |
≥98.5%--101.5% |
99.8% |
Conclusion:Conforms to BP2002 |
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