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Beanbag Design
 
  Benzodiazepine Series
CERTIFICATE OF ANALYSIS
   
PRODUCT LORAZEPAM
BATCH No LLOR-14/F/05/002
MFG. MARCH-2005
REFERENCE BP-2004 / Ph.Eur-5.0
   
A.R.No LC/05/062
DATE 23/03/2005
EXP. FEBRUARY-2010
   
TESTS
SPECIFICATION
RESULT
DESCRIPTION
A white or almost white crystalline powder
White Crystalline Powder .
SOLUBILITY
Practically insoluble in water, sparingly soluble in alcohol slightly or sparingly soluble in methylene chloride..
Complies
IDENTIFICATION
U.V.Spectrum of 0.001%w/v Solution in alcohol exhibits maxima at 230nm.
The Specific absorbance at the maximum should be 1070 to 1170
   
 I. R. Spectrum
Should Comply
   
 TLC Principal spot of substance is similar in position and size to that of working reference standard.
Should Comply

1160

 
Complies
 



Complies

RELATED SUBSTANCES
By TLC  
   
Any one impurity
NMT 0.2%
   
Any other second impurity
NMT 0.1%
 
 
< 0.2%
 
< 0.1%
LOSS ON DRYING
At 100-105 º C under high vacuum
Nmt 0.5%
0.3 %
SULPHATED ASH
 
NMT 0.1%
0.07%
RESIDUAL SOLVENTS
Methanol
NMT 3000 ppm
1-Propanol
NMT 5000 ppm
Acetone
NMT 5000 ppm
Hexane
NMT 290 ppm
Ethyl acetate
NMT 5000 ppm
Toluene
NMT 890 ppm
Not detected
Not detected
Not detected
Not detected
Not detected
Not detected

ASSAY (ON DRIED BASIS)

By Potentiometry
98.5% to 102.0%
100.0%

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

LORAZEPAM

BATCH No LLOR-14/F/05/002
MFG. MARCH-2005
REFERENCE USP-28
   
A.R.No LC-05/062
DATE 23/03/2005
EXP. FEBRUARY-2010
   
TESTS
SPECIFICATION
RESULT
DESCRIPTION
A white or Almost white odorless crystalline powder
Almost white odorless crystalline powder
SOLUBILITY
Practically insoluble in water. Sparingly soluble in alcohol (96%), slightly soluble in Chloroform.
Complies
IDENTIFICATION
I.R.Spectrum
Should comply
   
 TLC : The Rf value of the sample corresponds to that of working standard
Complies
 

Complies
LOSS ON DRYING
At 105 º C under vaccum for 3 hours
Nmt 0.5%
0.2%
RESIDUE ON IGNITION
At 100-105 º C under high vacuum
NMT 0.3%
0.07%
HEAVY METALS
 
NMT 0.002%
<0.002%
RELATED COMPOUNDS
BY TLC  
   
 Related compound ‘A’
NMT 0.2%
   
 Related compound ‘B’
NMT 290 ppm
   
 Total impurities
NMT 1.0 %
 
 
<0.2%
 
<0.01 %
 
<0.2%
RESIDUAL SOLVENTS
Methanol
NMT 3000 ppm
1-Propanol
NMT 5000 ppm
Acetone
NMT 5000 ppm
Hexane
NMT 290 ppm
Ethyl acetate
NMT 5000 ppm
Toluene
NMT 890 ppm
820 ppm
Not detected
Not detected
Not detected
Not detected
Not detected

ASSAY (ON DRIED BASIS)

By Potentiometry
98.0 to 102.0%
100.0%

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.