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obeticholic acid 459789-99-2 cas 459789-99-2
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Function
Is a semi-synthetic bile acid analogue which has the chemical structure 6α-ethyl-chenodeoxycholic acid. It has also been known as INT-747. It is undergoing development as a pharmaceutical agent for several liver diseases and related disorders.
TEST
|
SPECIFICATION
|
RESULT
|
Appearance
|
White to off-white crystals
|
White crystals
|
Identification
|
1-HNMR: Consistent with the standard
|
Conforms
|
IR: The IR absorption spectrum of the sample must be concordant with test Standard.
|
Conforms
|
|
HPLC: The HPLC spectrum of the sample must be concordant with the standard substance.
|
Conforms
|
|
Residue on ignition
|
NMT 0.2%
|
0.02%
|
Water
|
NMT 2.0%
|
0.06%
|
Heavy Metals
|
NMT 20ppm
|
5ppm
|
Related Substance
|
Impurity A: NMT 0.2%
|
0.07%
|
Impurity B: NMT 0.15%
|
0.03%
|
|
Impurity C: NMT 0.15%
|
0.07%
|
|
Any other impurity: NMT 0.10%
|
N.D.
|
|
Total impurities: NMT 1.0%
|
0.17%
|
|
Residual Solvents
|
Methanol: NMT 0.3%
|
N.D.
|
Ethanol: NMT 0.5%
|
N.D.
|
|
Ethyl acetate: NMT 0.5%
|
N.D.
|
|
Assay(By HPLC)
|
98.0%~102%
|
99.84%
|
Storage
|
Store in a tightly closed container in a cool and dry place, below 20℃.
|
|
Conclusion
|
Confirm to enterprise standard
|
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