Lake Chemicals
Home
About Us
Salient Features
Products
Documentation
Conatct Us
Site Map

New Launches
@Lakechemicals India

Beanbag Design
 
 

Benzodiazepine Series

CERTIFICATE OF ANALYSIS
   
PRODUCT ALPRAZOLAM
BATCH No LALP-9/F/05/004
MFG. MARCH 2005
REFERENCE Ph.Eur- 5.0 / BP- 2004
   
A.R.No LC/05/069
DATE 30/03/2005
EXP. FEBRUARY 2010
   
TESTS
SPECIFICATION
RESULT
DESCRIPTION
A white crystalline powder

White crystalline Powder
SOLUBILITY
Practically insoluble in water, freely soluble in Methylene chloride, sparingly soluble in acetone and in alcohol.
Complies
IDENTIFICATION
Mixed Melting point does not deviate from the melting point of test substance by more than 2°C
 
IR Spectrum
Should comply
 
 TLC
Should comply

226°C to 228°C
 
Complies
 
Complies
RELATED SUBSTANCES (BY HPLC)
Total impurities
NMT 0.25%
Complies
LOSS ON DRYING
At 105 °C
NMT 0.5%
0.3%
SULPHATED ASH
 
NMT 0.1%
0.07 %
ASSAY (ON DRIED BASIS)

By Potentiometry
99.0% to 101.0%
100.2 %
RESIDUAL SOLVENTS
Acetonitrile
NMT 410 ppm
Methanol
NMT 3000 ppm
Chloroform
NMT 60 ppm
Ethyl Acetate
NMT 5000 ppm
Pyridine
NMT 200 ppm
Toluene
NMT 890 ppm
Dimethylformamide
NMT 880 ppm
Not detected
19ppm
Not detected
15 ppm
Not detected
Not detected
357ppm
RESIDUAL SOLVENTS
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 ALPRAZOLAM
BATCH No LALP-9/F/05/004
MFG. MARCH 2005
REFERENCE USP-28
   
A.R.No LC/05/069
DATE 30/03/2005
EXP. FEBRUARY 2010
   
TESTS
SPECIFICATION
RESULT
DESCRIPTION
A white crystalline powder
Melting range at about 225°c
White crystalline Powder
227°C to 229°C
SOLUBILITY
Insoluble in water, slightly soluble in ethyl acetate, sparingly soluble in acetone, soluble in alcohol and freely soluble in chloroform.
Complies
IDENTIFICATION
 
IR Spectrum
Should comply
   
 U.V.Spectrum : Absorbtivities at 220nm
Should not differ by more than 3%.

Complies
 
1.1%
LOSS ON DRYING
At 60 °C and pressure not more than 5mm of Hg for 16 hours
NMT 0.5%.
0.3%

RESIDUE ON IGNITION

 
NMT 0.5%
0.07 %
HEAVY METALS

By Potentiometry
NMT 0.002%
<0.002%
CHROMATOGRAPHIC PURITY
 
By GC Total impurities
NMT 1.0 %
   
 By TLC a)Individual impurity
Should not differ by more than 3%.
   
 Total mpurities
NMT 1.0%
   
 
0.2 %
 
<0.3 %

 
<1.0%
 

ASSAY(ON DRIED BASIS)

By HPLC
98.0% to 102.0%
99.4%
RESIDUAL SOLVENTS
Acetonitrile
NMT 410 ppm
Methanol
NMT 3000 ppm
Ethyl Acetate
NMT 5000 ppm
Pyridine
NMT 200 ppm
Toluene
NMT 890 ppm
Dimethylformamide
NMT 880 ppm
Not detected
19ppm
15 ppm
Not detected
Not detected
357ppm
ORGANIC VOLATILE IMPURITIES
Chloroform
NMT 60 ppm
1,4-dioxane
NMT 380 ppm
Methylene chloride
NMT 600 ppm
Trichloroethylene
NMT 80 ppm
Not detected
Not used in the process. Hence 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.