USP Sildenafil Citrate




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Specifications

Purity 99.8%
Packaging Type Aluminium Bottle, HDPE drums, GI drums
A. R. NO SDC/17/004/08312
Cas No 171599-83-0
Form Powder
Assay 99%
Appearance White Powder
Price $ 5-50/kg
Packaging Size 25kg, 180kg, 200kg


Detail

TEST SPECIFICATION OBSERVATION
Description A white or almost white, slightly hygroscopic ,
crystalline powder
White powder
Solubility Slightly soluble in water and in methanol,
practically insoluble in hexane
Complies
Identification (BV IR) The IR absorption spectrum of the test sample
should be similar to that of working standard
Complies
Water by IG(%w/w) NMT 2.5% l.35Yo

Reiated substance by FIPLC (o/ow/w)
Organic impurities

Sildenafil related compound A

Unspecified impurities

total unspecifi ed impurities

Total irirpurities

 

NMT 0.3%

NMTO.I%

NMT 0.3%

 

NMT 0.5%

Complies

Complies

Complies

Complies

Residue on ignition NMTO.I% 0.07%
Heavy metal NMT 20 ppm Complies
Limit of imidazole NMT O.I% Complies
Assay by HPLC (Dry basis) (o/ow/w) Not lesS than98.0o/o and not more than 102.0% 99.85o/n

Residual solvent

Acetone

Methylene chloride

Ethyl acetate

Toluene

 

Not more thar 5000 ppm

Not more than 600 ppm

Not more than 5000 ppm

Not more than 890 ppm

 

Complies

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