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Raw Material sildenafil citrate

Raw Material Sildenafil Citrate

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

 
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