Calcitriol 1alpha,25-Dihydroxycholecalciferol Vitamin D3, 1a,25-Dihydroxy-
Item |
Requirements |
Test Results |
Appearance |
White or almost white crystalline powder |
Complies |
Identification |
Infrared spectrum corresponds to that of the standard preparation |
Complies |
The retention time of the major peak in the chromatogram corresponds to that in the chromatogram of standard preparation |
Complies |
|
Related substances(HPLC) |
Impurity B(7Z)-calcipotriol):≤0.5% |
ND |
Impurity C(5E)-calcipotriol)≤1.0% |
0.26% |
|
Impurity D(24-epi-calcipotriol)≤1.0% |
0.70% |
|
Any other impurity: ≤0.1% |
Complies |
|
Total impurities:≤2.5% |
1.1% |
|
Purity |
≥ 97.5% |
98.9% |
Loss on drying |
≤1.0% |
0.41% |
Residue on ignition |
≤0.10% |
0.04% |
Assay (dried substance) |
95.5%-102.0% |
99.6% |
Conclusion |
Complies with In house standard/EP6.0 |
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