Seema Biotech Powder SILDENAFIL CITRATE, Purity : 99%

SR NO

TEST

SPECIFICATION

RESULT

1.

Description

White or almost white slightly hygroscopic crystalline powder.

White Powder.

2.

Solubility

Slightly soluble in water and in methanol Practically insoluble in hexane.

Complies

3.

Identification

By IR

The IR absorption spectrum of sample should match to the spectrum of sildenafil citrate working standard.

Complies

4.

Limit of Imidazole by TLC (%)

Not more than 0.1

Complies

5.

Organic Impurity by HPLC (%)

Impurity-A                               Not more than 0.3

Any other Unspecified

Individual Impurity              Not more than 0.10

Total unspecified

Impurities                                Not more than 0.3

Total Impurities                      Not more than 0.5

Not Detected

0.05

0.05

0.05

6.

Water content by KF (% w/w)

Not more than 2.5

1.60

7.

Residue on Ignition

Not more than 0.1

0.06