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Beanbag Design
 
  Benzodiazepine Series
CERTIFICATE OF ANALYSIS
   
PRODUCT CLOBAZAM
BATCH No LCBZ-30/F/60
MFG. JANUARY - 2005
REFERENCE BP-2004 / Ph.Eur-5.0
   
A.R.No LC/05/010
DATE 19/01/2005
EXP. DECEMBER-2009
   
TESTS
SPECIFICATION
RESULT
DESCRIPTION
A white or almost white crystalline powder
White crystalline powder
SOLUBILITY
Slightly soluble in water, freely soluble in methylene chloride, sparingly soluble in alcohol.
Complies
IDENTIFICATION
I.R.Spectrum
Should comply
980 to 1080
RELATED SUBSTANCES
By HPLC  
   
 Impurity A
NMT 0.5%
   
 Any other individual impurity.
NMT 0.2%
   
 Total other  impurities
NMT 1.0%
 
 
0.03%
 

0.06%
 

0.10%

LOSS ON DRYING

At 100 - 105 º C
NMT 0.5 %
0.2%
SULPHATED ASH
 
NMT 0.1%
0.07%

ASSAY(ON DRIED BASIS)

By Potentiometry
97.0 % to 103.0%
99.6%
RESIDUAL OLVENTS
Methanol
NMT 3000 ppm
Ethyl acetate
NMT 5000 ppm
Hexane
NMT 290 ppm

N,N-Dimethylform-
amide
NMT 880 ppm
57 ppm
Not detected
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.