Specifications:
Items |
Specifications |
Results |
Description |
White Crystalline Powder |
White Crystalline Powder |
Solubility |
Souble In Dimethylformamide,sparingly Soluble In Acetic Acid And Slightly Soluble In Methanol. |
Conforms |
Identification By A) IR B)Test For Citrates |
The Absorption Maxima In The Spectrum Obtained With Sample Corresponds In Position Relative Intensity To Those In The Spectrum Obtained With Sildenafil Citrate CRS/working Standard Or With Reference Spectrum Of Sildenafil Citrate. To Complies As Per I.P |
Conforms |
Melting Range |
Between 182 ℃ To 196 ℃ |
188 ℃-192 |
Water By KFR |
NMT2.0% |
1.32%w/w |
Citric Acid Content |
28.0 To 34.0% W/w |
29.14w/w |
Loss On Drying At 105 ℃ |
NMT 1.0% W/w |
0.64%w/w |
Heavy Metals |
NMT 20 Ppm |
Conforms |
Sulphated Ash |
NMT 0.10% W/w |
Conforms |
Related Substance By HPLC |
N-Oxide Impurity NMT 0.50% Chloro Sulphonyl Impurity NMT 0.20% Any Other Impurity NMT 0.30% Total Impurities NMT 1.5% |
Not Detected Not Detected 0.07% 0.20% |
Standard |
USP28 |