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Beanbag Design
 
  Benzodiazepine Series
   
PRODUCT BROMAZEPAM
BATCH No LBZP-35/F/ 05/004
MFG. MAY-2005
REFERENCE BP –2004 / Ph.Eur 5.0
   
A.R.No LC/05/098
DATE 06/05/2005
EXP. MAY 2010
   
TESTS
SPECIFICATION
RESULT
DESCRIPTION
A white crystalline powder
White crystalline Powder
SOLUBILITY
Practically insoluble in water, sparingly soluble in alcohol and methylene chloride.
Complies
IDENTIFICATION
(a)U.V.Absorption
Specific Absorbance at 233 nm
980 to 1080
 
 I.R.Spectrum
Should Comply
 
 T.L.C
Should Comply
 
  By Chemical Test
Should Comply
 
  Reaction (a) of Bromides
Should Comply
 
1062
 
Should Comply
 
Should Comply
 
Should Comply
 
Should Comply
APPEARANCE OF SOLUTION
A 2.5%w/v solution in a mixture methanol and tetrahydrofuran (1:4) should be clear.
Complies

RELATED SUBSTANCE (BY TLC)

Any impurity
NMT 0.2%
< 0.2%
LOSS ON DRYING

At 80 º C at pressure not exceeding 2.7 KPa for 4 hours
NMT 0.2%
0.1 %
SULPHATED ASH
 
NMT 0.1%
0.07%

ASSAY(ON DRIED BASIS)

By Potentiometry
99.0 to 101.0%
100.5%
RESIDUAL OLVENTS
Methanol
NMT 3000 ppm
Acetone
NMT 5000 ppm
Hexane
NMT 290 ppm
Toluene
NMT 890 ppm
Chloroform
NMT 60 ppm
Not detected
Not detected
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.