Lake chemicals_products_Benzodiazepine Series _Midazolam (Base, Maleate, Hcl)

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	Benzodiazepine Series

CERTIFICATE OF ANALYSIS

PRODUCT

MIDAZOLAM

BATCH No

LMDZ - 26/F/05/002

MFG.

APRIL -2005

REFERENCE

BP-2004 / Ph.Eur-5.0


A.R.No	LC/05/079
DATE	13/04/2005
EXP.	MARCH-2010

TESTS

SPECIFICATION

RESULT

DESCRIPTION

A white or yellowish crystalline powder

Almost white Crystalline Powder

SOLUBILITY

Practically insoluble in water, freely soluble in acetone and in alcohol, soluble in methanol.

Complies

IDENTIFICATION

Melting Range	161°C to 164°C

I.R.Spectrum	Should Comply

T.LC	Should Comply

By chemical Test	Should Comply

Reaction (a) of Chlorides	Should Comply

161°C to 162°C

Complies

RELATED SUBSTANCES

By TLC

NMT 0.2%

Complies

LOSS ON DRYING

At 100 to 105 º C

NMT 0.5%

0.1%

SULPHATED ASH

NMT 0.1%

0.09%

ASSAY (ON DRIED BASIS)

By Potentiometry

98.5% to 101.5%

100.6%

RESIDUAL SOLVENTS

Methylene chloride	NMT 600ppm
Toluene	NMT 890ppm
Hexane	NMT 290ppm
Isopropyl alcohol	NMT 5000 ppm
Xylene	NMT 2170 ppm

Not Detected

Not detected

Particle size

90% less than 20 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.

PRODUCT

MIDAZOLAM HCl

BATCH No

LMDH-27/F/05/002

MFG.

APRIL -2005

REFERENCE

IN-HOUSE


A.R.No	LC/05/097
DATE	25/05/2005
EXP.	APRIL-2010

TESTS

SPECIFICATION

RESULT

DESCRIPTION

A white to pale yellow crystalline powder.

A white crystalline powder

SOLUBILITY

Practically insoluble in Acetone, soluble in Methanol, Sparingly soluble in Ethanol.

Complies

IDENTIFICATION

I. R. Spectrum

Should comply

Complies

RELATED SUBSTANCES

By HPLC

Individual impurity	NMT 0.5%

Total Impurities	NMT 1.0%

<0.5 %

<0.2 %

MOISTURE CONTENT

By KF Titration

NMT 1.0%

0.4 %

LOSS ON DRYING

NMT 0.5%

0.3 %

SULPHATED ASH

NMT 0.2%

0.07 %

ASSAY (ON DRIED BASIS)

By Potentiometry	98.5% to 101.5%

By HPLC	98.5 to 101.5%

99.5 %

99.3 %

RESIDUAL SOLVENTS

Methylene chloride	NMT 600ppm
Toluene	NMT 890ppm
Hexane	NMT 290ppm
Isopropyl alcohol	NMT 5000 ppm
Xylene	NMT 2170 ppm

Not Detected

Not detected

63 ppm

Not detected

Particle size

90% less than 20 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.

PRODUCT

MIDAZOLAM MALEATE

BATCH No

LMDM-28/ F/05/001

MFG.

FEBRUARY- 2005

REFERENCE

IN-HOUSE


A.R.No	LC/05/031
DATE	25/02/2005
EXP.	JANUARY – 2008

TESTS

SPECIFICATION

RESULT

DESCRIPTION

White to Cream coloured crystalline powder

Cream coloured powder

SOLUBILITY

Practicvally insoluble in water. Freely soluble in Methanol, sparingly soluble in Acetone, and in Methylene chloride

Complies

1.0% w/v suspension in water

3.5 to 4.5

4.1

WATER CONTENT

By KF Titration

NMT 1.0%

0.3%

IDENTIFICATION

I. R. Spectrum	Should comply

TLC	Should comply

Complies

RELATED SUBSTANCES

By HPLC

Individual impurity	NMT 0.5%

Total Impurities	NMT 1.0%

0.2 %

0.4%

LOSS ON DRYING

When dried at 105 ° C for 3 hrs

nmt 0.5%

0.3 %

SULPHATED ASH

NMT 0.1%

0.07 %

HEAVY METALS

NMT 10 ppm

<10 ppm

ASSAY (ON DRIED BASIS)

By Potentiometry	98.5% to 101.5%

By HPLC	98.5 to 101.5%

100.2%

100.1%

RESIDUAL SOLVENTS

Acetone	NMT 5000 ppm
Hexane	NMT 290ppm
Methylene chloride	NMT 600ppm
Toluene	NMT 890 ppm
Xylene	NMT 2170 ppm

124ppm

Not detected

485ppm

Not detected

Particle size

90% less than 20 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.