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FDA Approved
CGMP Certified
Manufacturing Company
CHLORHEXIDINE BASE IN HOUSE
Tests
Specifications
Description
A White to almost White powder
Identification { By IR}
To match with Reference Standard
Color Test (20% CHG Sol.)
Absorbance not more than 0.03 (Absorbance at 480 nm)
Sulphated ash
Not more than 0.1% w/w
Loss on drying at 105 oC % w/w.
Not more than 0.5 % w/w
Related substances by HPLC i] Single impurities% w/w ii] Total Impurities % w/w
Not more than 0.5 % w/w Not more than 1.0 % w/w
Assay
By HPLC : Not less than 98% and not more than 102%
By TITRATION: Not Less than 98% and note more than 102%
Para Chloro Aniline, ppm
Not more than 200 ppm
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