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sildenafil citrate

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Product Description




Sildenafil, sold as the brand name Viagra among others, is a medication used to treat erectile dysfunction and pulmonary arterial hypertension. Its effectiveness for treating sexual dysfunction in women has not been demonstrated. 

Common side effects include headaches and heartburn, as well as flushed skin. Caution is advised in those who have cardiovascular disease. Rare but serious side effects include prolonged erections, which can lead to damage to the penis, and sudden-onset hearing loss. Sildenafil should not be taken by people who take nitrates such as nitroglycerin (glycerin trinitrate), as this may result in a severe and potentially fatal drop in blood pressure. 

Sildenafil acts by inhibiting cGMP-specific phosphodiesterase type 5 (phosphodiesterase 5, PDE5), an enzyme that promotes degradation of cGMP, which regulates blood flow in the penis.

Pfizer scientists Andrew Bell, David Brown, and Nicholas Terrett originally discovered sildenafil as a treatment for various cardiovascular disorders. Since becoming available in 1998, sildenafil has been a common treatment for erectile dysfunction; its primary competitors are tadalafil (trade name Cialis) and vardenafil (Levitra).


Sildenafil Citrate

Chemical Name

17-HYDROXYYOHIMBAN-16-CARBOXYLIC ACID METHYL ESTER HYDROCHLORIDE

CAS Number

139755-83-2

EINECS Number

200-659-6

Molecular Formula

C22H30N6O4S

Molecular Weight

474.576

Melting Point

187-189℃

Boiling Point

672.4℃ at 760 mmHg

Flash Point

360.5℃

Vapour Pressure

6.1E-18mmHg at 25℃

Density

1.39g/cm3

Appearance

White amorphous/crystalline powder

Solubility

Freely soluble in acetyl choline, slightly soluble in methanol, insoluble in chloroform

Hazard codes

Xi, T, F

Specification

USP, 99.5%

Storage

Store in a cool, dry place. Keep containers tightly closed

Package

HDPE drum outside and aluminum foil bag inside. Or as required

Shelf life

Two years

 Usage

Treat erectile dysfunction and pulmonary arterial hypertension




CERTIFE OF ANALYSIS

Product Name

Sildenafil Citrate USP 39

din-5-yl)-4-ethoxyphenyl)sulfonyl)-4-methyl-,2-hydroxy-1,2,3-propanetricarbo

Batch No.

IDAN/20170818

Quantity

500kgs

Date of Mfg.

Aug. 2017

Exp. Date

Aug. 2022

 

S.No

TEST PARAMETER

SPECIFICATION

RESULT

1

Description

White or almost white, slightly hygroscopic crystalline powder.

White,slightly hygroscopic crystalline powder.

2

Solubility

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

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

3

Identification by IR

The infrared absorption spectrum of the postassium bromide disperstion bromide dispersion of the sample preparation should be exhibit maxima only at the same wave numbers as that of a similar preparation of Sildenafil citrate working  standard/Reference standard.

The infrared absorption spectrum of the potassium bromide dispersion of the sample preparation is exhibit maxima only at the same wave numbers as that of a similar preparation of Sildenafil citrate USP working standard.

4

Limit of Imidazole by TLC(%)

Not more than 0.1

Less than 0.1

5

Residue Solvents by GC

Acetone

Not more than 5000

11

Methylene chloride

Not more than 600

ND

Ethyl acetate

Not more than 5000

ND

Toluene

Not more than 890

ND

6

Organic Impurities by HPLC(%,w/w)

Related compound-A

Not more than 0.3

BDL

Any other unspecified individual impurity

Not more than 0.1

BDL

Total unspecified impurities

Not more than 0.3

BDL

Total impurities

Not more than 0.5

BDL

7

Water content by KF(%,w/w)

Not more than 2.0

1.2

8

Residue on ignition (%,w/w)

Not more than 0.1

0.06

9

Heavy Metals (ppm)

Not more than 20

Less than 20

10

Assay by HPLC(%,w/w)

Not less than 98.0 and Not more than 102.0

99.6