Product Name: Calcipotriol

Batch No.: 231201

Batch Size: 17g

Manufacturing Date:Dec. 01, 2023

Ref. Standard: EP7.0

Report Date: Dec. 01, 2023

Items

Spcifications

Results

Appearance

White or almost white crystalline powder

Conforms

Identification

a) IR

IR chromatograph Conforms to the

characteristic peak of R.S.

Conforms

b) HPLC

chromatogram Conforms to the

characteristic peak of R.S.

Conforms

Related substances

Known impurity

Impurity B((7Z)-calcipotriol)

Not more than 0.5%

ND

Impurity C((5E)-calcipotriol)

Not more than 1.0%

0.19%

Impurity D (24-epi-calcipotriol)

Not more than 1.0%

0.33%

Any other impurity

Not more than 0.1%

ND

Total impurities

Not more than 2.5%

0.50%

LOD

Not more than 1.0%

0.35%

Solvent residue

Acetone

Not more than0.5%

0.25%

Tetrahydrofuran

Not more than0.072%

ND

Ethyl acetate

Not more than0.5%

0.15%

Methanol

Not more than0.3%

0.132%

Toluene

Not more than0.089%

ND

Ethanol

Not more than0.5%

0.11%

Assay

95.5~102.0%

99.1%

Conclusion：It conforms to the Enterprise Standard

Storage: Store in a -20 ℃, keep sealed and kept from light.

Shelf Life: 2years