Product Name

Calcitriol

CAS No.

32222-06-3

Batch No.

20180526001

Standard

EP8.0

Mfg. Date

20180526

Expired  Date

20200525

TEST 

Specifications

Results

Appearance

White or almost white crystals

Conform

Solubility

Practically insoluble in water, freely soluble in alcohol, soluble in fatty olis.

Conform

Identification

Infrared spectrum corresponds to that of the standard preparation 

The retention time of the major peak in th chromatogram corresponds to that in the chromatogram of standard preparation 

Conform

Related Compounds

Triazoline adduct of pre-calcitriol: NMT 0.5%

Trans-calcitriol: NMT 0.5%

1β-Calcitriol: NMT 0.5%

Any other individual impurity: NMT 0.1%

Total impurities: NMT 1.0% 

ND

0.13%

ND

Conform

0.22%

Purity 

NLT99.0%

99.78%

Loss on Drying

NMT 0.5%

＜0.05%

Heavy metal

NMT 20ppm

Conform

Residue on ignition

NMT 0.1%

＜0.05%

Assay

97.0~103.0%

99.9%

Conclusion

The results conform to the EP8 specification

Storage

In N_2, air/light free, under 4℃