CERTIFICATE OF ANALYSIS

Product: Amiodarone Hydrochloride		Report Date: 2004-10-14
Batch No.: 041002		Manufacture Date : 2004-10-12
Batch Size: 300 Kg		Expiry Date: 2007-10-12
Package : 25 Kg/Drum
Subject	BP2000 & EP4.01 Standard		Result
Description	White Or Almost White Crystalline Powder		White Crystalline Powde
Identification	Qualified		Qualified
Melting Point	159 ℃~ 163 ℃		159.5 ℃~ 160.5 ℃
Appearance Of Solution	< GY 5		< GY 5
PH	3.2 ~ 3.8		3.62
Related Substances	Total impurities ≤ 0.5%		< 0.5%
	Single impurities ≤ 0.2%		< 0.2%
Iodides	< 0.015 %		< 0.015%
Heavy Metals ( Pb )	≤ 0.002 %		< 0.002%
Loss On Drying	≤ 0.5 %		0.10%
Sulphated Ash	< 0.1%		0.01%
Content	98.5% ~ 101.0%		100.0%
Conclusion: Up To BP2000 & EP4.01 Standard

Director: Wenmin Pan Inspector: Lingping Li Reviewer: Wenmin Pan