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Batch No.
200202
Approval Date
Mfg. Date
14/02/2020
Exp. Date
Tests
Results
Specifications
Character
Complies
The product should be yellow crystalline powder, have a bad smell.
Melting point
61ºC~62ºC
60ºC~62ºC
Identification
Complies
Chemistry reaction, should be positive reaction
Complies
UV spectrophotometry, should comply
Complies
By IR absorption, to match with the working standard
Related substances
0
For chromatograms of the test solution, if there are impurity peaks (excluding solvent peaks), the impurity A peak area with a relative retention time of about 2.1 multiplied by the correction factor 0.6 should not be larger than the main peak area of the control solution
(0.10%)
0
The single peak area due to impurities should not be
greater than the principal peak area of the reference solution(0.10%)
0
The sum of area of all impurity peaks in the chromatogram obtained with the test solution should not be greater than the area of the principal peak in the chromatogram obtained with the reference
solution(0.30%)
Clarity and colour of solution
Complies
In case of color development, it shall not be deeper than the yellow-green no. 5 standard color liquor.