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Beanbag Design
 
  Benzodiazepine Series
CERTIFICATE OF ANALYSIS
   
PRODUCT CLONAZEPAM
BATCH No LCZP-13/F/ 05/001
MFG. FEBRUARY - 2005
REFERENCE BP-2004 / Ph.Eur-5.0
   
A.R.No LC/05/010
DATE 28/02/2005
EXP. JANUARY - 2010
   
TESTS
SPECIFICATION
RESULT
DESCRIPTION
Slightly yellowish, crystalline powder
Slightly yellowish, crystalline powder
SOLUBILITY
Slightly soluble in alcohol and in methanol, practically insoluble in water.
Complies
IDENTIFICATION
I.R.Spectrum
Should comply
Complies
MELTING POINT
 
About 239° C
237 to 238° C

LOSS ON DRYING

At 105 ºC
NMT 0.5%
0.3%
SULPHATED ASH
 
NMT 0.1%
0.08%

RELATED SUBSTANCES

By HPLC  
   
Impurity ‘A’
NMT 0.1 %
   
b) Impurity ‘B’
NMT 0.1 %
 
c) Any other Impurity
NMT 0.1 %
   
d) Total Impurities
NMT 0.2 %
 
 
Not detected
 
Not detected
 

0.09 %
 
0.18 %

ASSAY (ON DRIEDBASIS)

By Potentiometry
99.0 % - 101.0%
99.3 %
RESIDUAL OLVENTS
Acetone
NMT 5000 ppm
Toluene
NMT 890 ppm
Methanol
NMT 3000 ppm
N- propyl alcohol
NMT 5000 ppm
290 ppm
Not detected
1480 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 CLONAZEPAM
BATCH No LCZP-13/F/05/001
MFG. FEBRUARY - 2005
REFERENCE USP-28
   
A.R.No LC/05/033
DATE 28/02/2005
EXP. JANUARY - 2010
   
TESTS
SPECIFICATION
RESULT
DESCRIPTION
A Light yellow to off white powder, having a faint odour.
Off White Powder, having a faint odour.
SOLUBILITY
Practically insoluble in water, slightly soluble in alcohol and in ether. Sparingly soluble in acetone and in Chloroform.
Complies
IDENTIFICATION
I.R.Spectrum
Should comply
Complies
MELTING RANGE
 
237° C to 240 ° C
237°C to 238°C
LOSS ON DRYING
At 105 ° C for 4 hrs
NMT 0.5%
0.3 %
RESIDUE ON IGNITION
 
NMT 0.1%
0.08%
HEAVY METALS
 
NMT 0.002%
<0.002%
RELATED COMPOUND ’C’
By TLC
NMT 0.2%
<0.2%
RELATED COMPOUNDS
By HPLC  
   
  3 amino 4-(2 chlorophenyl) 6 nitro carbostyril
NMT 0.1%
   
  2-amino-2' chloro   5-nitro benzophenone
nmt 0.1%
   
 Any unknown impurity
nmt 0.2%
   
 Total impurities
nmt 0.3%
   
 
 

Not detected
 

Not detected
 
0.09%
 
0.23%
 

ORGANIC VOLATILE IMPURITIES

Chloroform
NMT 60 ppm.
 
1,4 dioxane
NMT 380 ppm
 
Methylene chloride
NMT 600 ppm
 
Trichloroethylene
NMT 80 ppm
Not used in the process and Hence Not Detected when tested
RESIDUAL OLVENTS
Methanol
NMT 3000 ppm
Acetone
NMT 5000 ppm
N- Propyl alcohol
NMT 5000 ppm
Toluene
NMT 890 ppm
1480 ppm
290 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.