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CERTIFICATE OF ANALYSIS

PRODUCT

NIMESULIDE

BATCH No

LNSL-16/F/05/003

MFG.

JANUARY – 2005

REFERENCE

Ph. Eur-5.0/BP-2004


A.R.No	LC/05/005
DATE	10/01/2005
EXP.	DECEMBER- 2009

TESTS

SPECIFICATION

RESULT

DESCRIPTION

A yellowish crystalline powder. It shows polymorphism.

Yellowish Crystalline Powder.It shows polymorphism

SOLUBILITY

Practically insoluble in water, freely soluble in acetone, slightly soluble in ethanol.

Complies

MELTING RANGE

About 149°C

147– 149°C

IDENTIFICATION

IR Spectrum

Should comply

Complies

ABSORBANCE

Abs of 10% solution in acetone at 450 nm

NMT 0.5 Abs

0.188Abs

HEAVY METALS

NMT 20ppm

< 20 ppm

LOSS ON DRYING

When dried at 105°C for 4 hours

NMT0.5%

0.3%

RELATED SUBSTANCES

BY HPLC

Any impurity	NMT 0.5 %

Total impurities	nmt 0.1%

0.08%

0.1%

SULPHATED ASH

NMT 0.1%

0.06%

ASSAY (ON DRIED BASIS)

By Potentiometry	98.5% to101.5%

99.4%

RESIDUAL SOLVENTS


Toluene	NMT 890 ppm
Acetone	NMT 5000 ppm

Not detected

CONCLUSION: THE PRODUCT COMPLIES WITH THE ABOVE SPECIFICATIONS.

None of this products will be supplied to countries in which there could be conflict with existing patents. However, the final responsibility lies exclusively with the buyer.