Appearance

White or almost white crystals

White crystals

Solubility

Practically insoluble in water, freely soluble in ethanol (96 percent), soluble in fatty oils.

Complies

Identification

The IR spectrum obtained is in concordance with the reference standard.

Complies

The principal peak in chromatogram obtained with the test solution is similar in retention time and size to the principal peak in chromatogram obtained with reference solution.

Complies

Related Substances

Relative retention: with reference to Calcifediol (retention time = about 11 min)

Impurity A = about 1.6 (≤0.5%),

Impurity B = about 1.1 (≤0.5%)

Impurity C = about1.2 (≤0.5%)

Impurity D = about 0.85 (≤0.5%)

Single unspecified impurities (≤0.1% MAX)

Total of impurities (≤1.0%)

Not detected

0.02%

Not detected

0.03%

Not detected

0.05%

Water

3.8%~5.0%

4.11%

Assay

97.0%-102.0%

99.9%

Conclusion: The product conforms to the EP8.0 standard.