Ursodeoxycholic acid

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10 Kilogram	Negotiable

10 Kilogram

Negotiable

Ursodeoxycholic Ursodeoxycholic acid UDCA

1. GMP AVALIABLE ;

2. IN STOCK

3. FAST REPLY

QUALIFED ; EFFICIENCY; RESPONSIBLE

NATURE OF TEST	QUALITY STANDARD	TEST RESULTS
CHARACTERS:
-Appearance	White or almost white powder	Conforms
-Solubility	Practically insoluble in water, freely	Conforms
	soluble in ethanol (96 per cent), slightly
	soluble in acetone, practically insoluble in
	methylene chloride.
TESTS:
-Melting point	About 202 ℃	202℃
-Identification
- IR	The spectrum obtained is similar to	Conforms
	that of CRS
-Sepcific optical rotation	+ 58.0~+62.0	+61.3°
-Sulphate Ash	≤ 0.1 %	0.04%
-Related substances(TLC)
- Chenodeoxycholic Acid	≤ 1 %	< 1 %
- Lithocholic Acid	≤ 0.1 %	not detected
- Cholic Acid	≤ 0.5 %	not detected
- any other impurity	≤ 0.25 %	not detected
-Loss on Drying	≤ 1.0 %	0.04%
-Heavy metal	≤ 20 ppm	< 20 ppm
ASSAY :	99.0 %~101.0 %	100.7%
-On dry substance	99.0 %~101.0 %	100.7%
CONCLUSION: THE TEST RESULTS CONFORM TO EP

RESIDUAL SOLVENTS:
- Methanol	≤3000 ppm	not detected
- Isopropanol	≤5000 ppm	not detected
- Ethylacetate	≤5000 ppm	not detected
MICROBIOLOGICAL TESTS:
-Total Plate Count /1 g	＜ 1000	＜ 10
-Yeast & Mould /1 g	＜ 100	＜ 10
-E. coli /1 g	Absent	Absent
CONCLUSION: THE TEST RESULTS CONFORM TO MICROBIOLOGICAL TESTS.