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CERTIFICATE OF ANALYSIS
   
PRODUCT

HALOPERIDOL

BATCH No LHAP-7/ F/05/006
MFG. APRIL -2005
REFERENCE USP-28
   
A.R.No LC/05/088
DATE 07/05/2005
EXP. MARCH -2010
   
TESTS
SPECIFICATION
RESULT
DESCRIPTION
White to faintly yellowish, amorphous or microcrystalline powder.

White amorphous powder

SOLUBILITY
Practically Insoluble in water, soluble in chloroform, sparingly soluble in alcohol, slightly soluble in ether.
Complies
IDENTIFICATION
 I. R. Spectrum
Should comply
   
 Ultraviolet abs spectrum in dilute HCl (1 in 100 ) in isopropyl alcohol (1 in 9). Absorbitivites at 245nm,
NMT 3%
Complies
 



1.05 %


MELTING RANGE
 
149 to 155 ºC
150ºC to 151ºC
LOSS ON DRYING
At 60°C under vacuum for 3 hrs.
NMT 0.5%
0.3%
RESIDUE ON IGNITION
 
NMT 0.1%
0.07%
LIMIT OF HALOPERIDOL RELATED COMPOUND ‘A’
By UV Spectrophotometry
NMT 1.0%
0. 2 %
ASSAY (ON DRIED BASIS)
By Titrimetry
98.0% to102.0%
100.3%
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 not detected when tested




RESIDUAL SOLVENTS
   
Methanol
NMT 3000 ppm
Toluene
NMT 890 ppm
Ethyl acetate
NMT 5000 ppm
Isopropyl alcohol
NMT 5000 ppm
Tetrahydrofuran
NMT 5000 ppm
   
 
Not detected
Not detected
Not detected
Not detected
Not detected
 
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

HALOPERIDOL

BATCH No LHAP-7/F/05/001
MFG. JANUARY - 2005
REFERENCE IP
   
A.R.No LC/05/015
DATE 02/02/2005
EXP. DECEMBER - 2009
   
TESTS
SPECIFICATION
RESULT
DESCRIPTION
White to faintly yellowish, amorphous or micro crystalline powder, odourless.

White powder

SOLUBILITY
Soluble in chloroform, sparingly soluble in ethanol (95%) and in methylene chloride. Slightly soluble in ether. Practically insoluble in water.
Complies
IDENTIFICATIONS
 I. R. Spectrum
Should comply
 
 U.V.absorption
Should comply
 
T.L.C
Should comply
 
 Dinitrobenzene Test
Should comply
 
 Zirconylnitrate test
Should comply
 
 Reactions ofchloride
Should comply
Complies
 
Complies
 
Complies
 

 
Complies
 
Complies
MELTING RANGE
 
147 to 152 °C
150 to 151 ° C
RELATED SUBSTANCES
BY TLC  
   
Total impurities
NMT 0.5%
 
 
< 0.5 %
LOSS ON DRYING
At 60 º C at a pressure not exceeding 0.1 kPa for 3 hours
NMT 0.5%
0.2%
SULPHATED ASH
 
NMT 0.1%
0.07%
HEAVY METALS
 
NMT 10 ppm
<10 ppm
ASSAY (ON DRIED BASIS)
By Titrimetry
99.0% to 101.0%
100.7%
RESIDUAL SOLVENTS
Ethyl Acetate
NMT 5000 ppm
Iso propyl alcohol
NMT 5000 ppm
Methanol
NMT 3000 ppm
Tetrahydrofuran
NMT 5000 ppm
Toluene
NMT 890 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.