CERTIFICATE OF ANALYSIS

Product Name yu re
Batch Number : 90011221 Quantity : 150.0 gm
MFG. Date : DEC-2021 Retest date : NOV-2022

Analysis date : 23/12/2021 AR Number : AR/INT/67/007/21

S.No
Test Specification Result
.
Light brown to pale yellow coloured Pale yellow
01 Description coloured crystalline
crystalline powder.
powder.
02 Solubility Soluble in methanol Complies
The retention time of the major peak in the
a) By HPLC sample chromatogram should correspond to Complies
that of standard chromatogram
03
The Infrared absorption spectrum of the
B) By IR sample should be concordant with the Complies
standard spectrum.
04 Melting Range Between 67°C and 75°C 71.9°C-72.8°C
05 Water content by KF(%) Not more than 0.50 % w/w 0.21%
06 Residue on ignition Not more than 0.50 % w/w 0.11%
Chromatographic purity by HPLC (% area normalization)
a)Purity Not less than 99.0% 99.7%
07
b) Any individual impurity Not More than 0.50% 0.03%

c)Total impurities Not More than 1.0% 0.30%

08 Assay by HPLC on 99.8%

Not less than 99.0
anhydrous basis (%w/w

Remarks: The above product complies as per above specifications

Prepared by Reviewed by Released by

rr

Quality Control Sign/Date

Quality Control Sign/Date
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