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G. AMPHRAY LABORATORIES
E-mail : info@amphray.com
Sambava Chambers, 4th Floor, Sir P. M. Road, Mumbai 400 001, INDIA.
Web : www.amphray.com
CERTIFICATE OF ANALYSIS
Name of Product
Batch No.
Date of Manufacture
Date of Expiry
Quantity
:
:
:
:
:
PARACETAMOL BP
003/08
May, 2008
April, 2013
3,000 KGS
Date of Receipt :
Date of Analysis :
Sample Size
:
Q.C.No.
:
08.05.2008
08.05.2008
100 Grams
G-08/093
RESULTS OF ANALYSIS
TESTS
Description
Solubility
RESULTS
A white crystalline powder.
Complies.
Identification
Second Identification :
A. Melting Point : 171.8 C
B. The specific absorbance at 249 nm : 884.85
D. Complies
Heavy Metals
4 Aminophenol
Related
Substances
Loss on Drying
Sulphated Ash
Assay ( On Dried
Basis )
SPECIFICATIONS
A white crystalline powder.
Sparingly soluble in water, freely
soluble in alcohol, very slightly
soluble in ether and in methylene
chloride.
E. Complies
< 20 ppm
02 ppm
< 0.005 %
0.12 %
0.029 %
99.78 % of C8H9NO2
ADDITIONAL TEST
1) Particle size on Tyler Machine:MESH
% PASSING THROUGH
50
100 %
60
97.08 %
2 Bulk density after 50 Tapped = 0.573 g/ml
REPORT: THE SAMPLE COMPLIES WITH THE PRESCRIBED STANDARDS OF QUALITY AS PER BP 2002
Certified True Copy
For G. AMPHRAY LABORATORIES
AUTHORISED SIGNATORY
Plant 1: 43/2, Narpoli, Amina Compound, Near Dhamankar Naka, Bhiwandi - 421 302. MAHARASHTRA
Plant 2: 10/1 MIDC Industrial Area, Ambernath - 421 510. MAHARASHTRA
G. AMPHRAY LABORATORIES
E-mail : info@amphray.com
Sambava Chambers, 4th Floor, Sir P. M. Road, Mumbai 400 001, INDIA.
Web : www.amphray.com
CERTIFICATE OF ANALYSIS
Name of Product
Batch No.
Date of Manufacture
Date of Expiry
Quantity
:
:
:
:
:
PARACETAMOL EP
003/08
May, 2008
April, 2013
3,000 KGS
Date of Receipt :
Date of Analysis :
Sample Size
:
Q.C.No.
:
08.05.2008
08.05.2008
100 Grams
G-08/093
RESULTS OF ANALYSIS
TEST
Appearance
RESULTS
Conforms
LIMITS
White odorless Crystalline Powder
Solubility
METHOD
Organoleptic
Test
Visual Test
Conforms
Identification A
EP 2002, 2.2.14
171.9
Identification C
Loss on Drying
Sulphated Ash
Heavy Metals
Assay
Related Substances 1)
Impurity J2)
Impurity K3)
Impurity F4)
Unknown Single
Total Impurities
1 Disregard Limit 0.01 %
2 Chloroacetanilide
3 4-Aminophenol
4 4-Nitrophenol
EP 2002, 2.2.24
EP 2002, 2.2.32
EP 2002, 2.4.14
EP 2002, 2.4.8
EP 2002, 2.2.20
EP 2002, 2.2.29
Conforms
0.19 %
0.030 %
< 20 ppm
99.80 %
< 5 ppm
< 5 ppm
< 0.01 %
< 0.01 %
< 0.05 %
< 10 ppm
< 50 ppm
< 0.05 %
< 0.05 %, Individually
< 0.1 %
AUTHORISED SIGNATORY
Plant 1: 43/2, Narpoli, Amina Compound, Near Dhamankar Naka, Bhiwandi - 421 302. MAHARASHTRA
Plant 2: 10/1 MIDC Industrial Area, Ambernath - 421 510. MAHARASHTRA