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Amoxicillin Trihydrate USP 23 Compacted                                                   

TESTS SPECIFICATIONS
Description White or almost white granular powder   
Identification IR Spectrum     
Solubility ¡¡
pH                                        3.5 – 5.5    
Water (K.F) 11.5 - 14.5 %         

Specific Optical Rotation

+290¡Æ ~ +315¡Æ                        
Related substances

 Total impurities (HPLC)

 Major individual Impurities

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NMT 5.0%      

NMT 1.0%       

Appearance of solution By EP 98       
N,N-Dimethylaniline NMT 20 ppm    
Sulphated Ash NMT 1.0% w/w
Bulk density (Tapped)

 (ASTM B527-93)

NLT 0.75g/m
Assay

(as anhydrous basis, HPLC)

95.0% ~ 100.5% 
Date of Expiration 4 years from manufacturing date