Ursodeoxycholic Acid   (UDCA)


CAS NO. :128-13-2

Pharmacopoeia standard :——

HS CODE : 3504.0090.00

File service :——


Characters:White powder; odorless. This product is soluble in ethanol, but insoluble in chloroform; soluble in glacial acetic acid, and soluble in sodium hydroxide test solution.

Process:Synthetic.


product details


Test Items

According to internal standard and Customer Standard

APPEARANCE

White or almost white powder.

MELTING RANGE

Between 200°C and 205°C

SPECIFIC ROTATION

+57.0 +62.0°

LOSS ON DRYING

0.5%

RESIDUE ON IGNITION

0.1%

ASSAY

98.5%101.5% (Dried substance)

PURITY (HPLC)

98.5%

RELATED SUBSTANCE (HPLC)

1.5% (Chenodeoxycholicacid)

Not detected

0.1% (Unspecified impurities)

0.05%

0.1% (Lithocholicacid)

Not detected

1.5% (Total)

0.1%

RELATED SUBSTANCE (TLC)

O.05% (Lithocholic acid)

Complies

1.5% (Chenodeoxycholicacid)

Complies

RESIDUAL SOLVENT

Acetone5000ppm

TOTAL AEROBIC MICROBIAL COUNT

103cfu/g

TOTAL COMBINED YEAST/MOULDS COUNT

102cfu/g

E.COLI

Complies

SALMONELLAE

Complies

CONCLUSION

Qualified


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