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CERTIFICATE OF ANALYSIS

PRODUCT

LOPERAMIDE HCl

BATCH No

LLPR-21/F/ 05/001

MFG.

MAY -2005

REFERENCE

BP-2004/Ph.Eur- 5.0


A.R.No	LC/05/104
DATE	13/05/2005
EXP.	APRIL - 2010

TESTS

SPECIFICATION

RESULT

DESCRIPTION

A White or almost white powder.

White powder

SOLUBILITY

Slightly soluble in water, freely soluble in methanol and in alcohol.

Complies

IDENTIFICATION

IR Spectrum

Should comply

Complies

LOSS ON DRYING

At 100-105ºC for 4 hours

NMT 0.5%

0.3%

RELATED SUBSTANCES

BY HPLC

Impurities A to H	NMT 0.2 %

Any other impurity	NMT 0.1 %

Total impurities	NMT 0.3 %

Not detected

0.03 %

0.08 %

SULPHATED ASH

NMT 0.1%

0.08%

ASSAY (ON DRIED BASIS)

By Potentiometry	99.0% to101.0 %

99.6%

RESIDUAL SOLVENTS


Methanol	NMT 3000 ppm
Acetone	NMT 5000 ppm
Chloroform	NMT 60 ppm
Iso propanol	NMT 5000 ppm
Hexane	NMT 290 ppm
Toluene	NMT 890 ppm
Tetrahydrofuran	NMT 5000 ppm

388 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.

PRODUCT

LOPERAMIDE HCl

BATCH No

LLPR21/F/ 05/002

MFG.

JUNE-2005

REFERENCE

USP-28


A.R.No	LC/ 05/118
DATE	09/06/2005
EXP.	MAY-2010

TESTS

SPECIFICATION

RESULT

DESCRIPTION

A White or almost white powder.

White powder

SOLUBILITY

Slightly soluble in water, freely soluble in methanol and in alcohol.

Complies

IDENTIFICATION

IR Spectrum	Should comply

U.V. absorption spectrum	Should comply

Complies

MELTING RANGE

About 225° C with decomposition

226°C to 227

LOSS ON DRYING

At 80 º c under vacuum for 4 hours

NMT 0.5%

0.2%

RESIDUE ON IGNITION

NMT 0.2%

0.08%

HEAVY METALS

NMT 0.002%

<0.002%

CHROMATOGRAPHIC PURITY

By TLC : The spot obtained from the test solution should corresopond R F value, color and intensity to that obtained from the standard solution, and no secondary spots are observed.

Complies

CHLORIDE CONTENT

13.52% to 14.20%

13.8%

ORGANIC VOLATILE IMPURITIES

1,4-Dioxane	NMT 380 ppm
Methylene Chloride	NMT 600 ppm
Trichloroethylene	NMT 80 ppm
Chloroform	NMT 60 ppm

Not used in the process and not detected

Not Detected

SULPHATED ASH

NMT 0.1%

0.08%

ASSAY (ON DRIED BASIS)

By Potentiometry	98.0% to 102.0 %

99.2%

RESIDUAL SOLVENTS


Methanol	NMT 3000 ppm
Acetone	NMT 5000 ppm
Iso propyl alcohol	NMT 5000 ppm
Toluene	NMT 890 ppm
Hexane	NMT 290 ppm
Tetrahydrofuran	NMT 5000 ppm

181ppm

Not detected

1484ppm

10ppm

Not detected

165ppm

Particle Size

90% less than 50 microns

Complies

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.