Thursday, January 13, 2011

WORKSHEET FOR STABILITY STUDY


Mfg. Date
:
Date of Testing
:
Month after
:


Sr. No.
Tests
Analyzed by
Sign/date
01
APPEARANCE
White to light yellow amorphous
 powder almost odorless
Observation:



02
SOLUBILITY 
Solution of the mineral acids, in alcohol, 
In ether, and in chloroform. Freely soluble in formic acid
Observation:



03
IDENTIFICATION (IR)
Complies with infrared spectrum, with USP.CRS.OR .WS
Observation:









04
LOSS  ON DRYING/ MOISTURE CONTENT
Not more than  0.5% w/w
Dry @ 105ยบ C for 4 Hrs
Observation:



05
RESIDUE ON IGNITION
Not more than 0.1%
Observation:



06

HEAVY  METALS                             
Not more than  0.002%
Observation:



07


CHROMATOGRAPHIC PURITY                        
As per USPXXXI
Observation:



09
ASSAY     

Not less than 98.0 % and not more
than 102.0%
Observation:





Remarks: Product is complies / does not comply as per laid down specification.



Checked By: ___________(Sign/Date)

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