Udca-Ursodeoxycholic Acid 99.0%Min USP/Ep/Bp/Jp/IP-Treatment of Gallstone Disease Ursodeoxycholic Acid Udca

• Pharmacopoeia: USP/Ep/Bp/Jp/IP
• Function: Treatment of Gallstone Disease
• Transport Package: 25kg/Drum
• Specification: 99.0%
• Trademark: China
• Origin: Sinochem
• Model NO.: Pharma Grade
• HS Code: 29372900
• Production Capacity: 15t/Year

Product Description

CERTIFICATE OF ANALYSIS



 

Product	Ursodeoxycholic Acid (UDCA)	Batch No.	201705002
Expiry Date	2017.APR.26	Retest Date	2020.APR.25
Quantity	100KG	CAS NO.	128-13-2

 
 

Item	Specification	Results
Appearance	White or almost white powder	Complies
Solubility	Practically insoluble in water, freely soluble in ethnol (96%), slightly soluble in acetone, Practically insoluble in methylene chloride.	Complies
Identification	Infrared Absorption, TLC and chrominance test	Complies
Melting Point	200-204ºC	202.5ºC
Specific         Optical Rotation	+58.0°~ +62.0°	+60.2°
Heavy metals	≤20 ppm	Complies
Loss on drying	≤1.0%	0.12%
Sulphated ash	≤0.1%	0.04%
Residual solvents	Acetone ≤0.5%	0.10%
	Methanol ≤0.3%	None
	Secondary butyl alcohol ≤0.5%	None
Related        substance (TLC)	Lithocholic Acid: ≤ 0.1%	Complies
	Cholic Acid: ≤ 0.5%	Complies
	Chenodeoxycholic Acid: ≤ 1.0%	Complies
	Others: ≤ 0.25%	Complies
Assay	99.0-101.0%	99.8%

 
Microbiological Tests

Specifications	Standard	Testing Result
Total Plate Count /1g	1000 MAX	10 MAX
Yeast & Mould /1g	100 MAX	10 MAX
E.coli /1g	Absent	Absent