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G. Amphray Laboratories: Results of Analysis Test Result Specification

This certificate of analysis summarizes the results of testing a batch of the drug Simvastatin produced by G. Amphray Laboratories. The batch number is SV288/12/2004 with a manufacturing date of December 2004 and expiry date of November 2007. Tests were performed on a 50 kg sample received on December 20, 2004. All test results, including identification, purity, residual solvents, particle size, and BHT content were within specified limits for Simvastatin according to European Pharmacopoeia monograph 5.0. The sample is certified to comply with EP specifications.

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66 views

G. Amphray Laboratories: Results of Analysis Test Result Specification

This certificate of analysis summarizes the results of testing a batch of the drug Simvastatin produced by G. Amphray Laboratories. The batch number is SV288/12/2004 with a manufacturing date of December 2004 and expiry date of November 2007. Tests were performed on a 50 kg sample received on December 20, 2004. All test results, including identification, purity, residual solvents, particle size, and BHT content were within specified limits for Simvastatin according to European Pharmacopoeia monograph 5.0. The sample is certified to comply with EP specifications.

Uploaded by

Gusnan Xtrada
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Intl Tel/Fax Code : 00 91 22

Tel.: 4082 8100 * 22 66 3150


Fax: 4082 8181 * 2202 4657

G. AMPHRAY LABORATORIES

E-mail : [email protected]

Sambava Chambers, 4th Floor, Sir P. M. Road, Mumbai 400 001, INDIA.

Web : www.amphray.com

CERTIFICATE OF ANALYSIS
Product
Batch No.
Date of Mfg.
Date of Expiry

:
:
:
:

SIMVASTATIN EP [COS Material]


SV288/12/2004
December, 2004.
November, 2007.

A. R. No
Date of receipt
Date Analysis
Quantity

:
:
:
:

FP 288/2004
20.12.2004
20.12.2004
50.00 KGS

RESULTS OF ANALYSIS
TEST

RESULT

Description

A white crystalline powder.

Solubility

Practically insoluble in water, very


soluble in methylene chloride, freely
soluble in alcohol.

Identification
A. Specific
Optical
Rotation
B. Infrared Absorption
Appearance of solution
Specific Optical Rotation
Heavy Metal
Loss on Drying ( at 60 C for 3
Hrs. ) under vacuum
Sulphated Ash
Related Substances ( By HPLC )
A. Hydroxy Acid
B. Acetate Ester
C. AnhydroSimvastatin
D. Dimer
E. Lovastatin
&
F.
Epilovastatin
Sum of all the area of all peaks
apart from principle peak and
peak due to Lovastatin &
Epilovastatin.
Assay of Simvastatin , C25H38O5
Residual Solvents
A. Methanol
B. THF
C. Hexane
D. Toluene
Particle Size
A. < 10 %
B. > 90 %
BHT Content ( By HPLC )

Complies.
Complies.

SPECIFICATION
A white or almost white crystalline
powder.
Practically insoluble in water, very soluble
in methylene chloride, freely soluble in
alcohol.

1 % solution in methanol is clear and not


more intensely colour than BY7 standard.
+ 291
< 20 ppm
0.23 %

Complies for test of specific optical


rotation.
IR spectra concordant with spectrum
obtained with Simvastatin CRS.
1 % solution in methanol is clear and not
more intensely colour than BY7 standard.
From + 285 to 300 on dry basis.
Maximum 20 ppm
Not more than 0.5 %

0.01 %

Not more than 0.1 %

0.10 %
0.19 %
NIL
0.05 %
0.18 %
0.43 %

Not more than 0.4 %


Not more than 0.4 %
Not more than 0.4 %
Not more than 0.4 %
Not more than 1.0 %
Not more than 1.0 %

99.10 %

Contains not less than 97.0 % and not more


than 102.0 % of Simvastatin, C25H38O5
As per ICH Guideline.
3000 ppm
720 ppm
290 ppm
890 ppm
As per In-house specification
Not more than 5 m
Not more than 20 m
Between 0.005 % & 0.015 %

62 ppm
70 ppm
25 ppm
NIL
4.5 m
18.5 m
0.007 %

REMARK: THE ABOVE SAMPLE COMPLIES AS PER THE SPECIFICATION OF E.P. 5.0
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

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