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Pharmaceutical Intermediates

Sildenafil citrate

CAS: 171599-83-0

Overview

Sildenafil citrate (CAS 171599-83-0 ), also marketed under the brand names Viagra and Revatio, is a phosphodiesterase type 5 (PDE5) inhibitor used as an active pharmaceutical ingredient in prescription drug manufacturing.

It is procured by pharmaceutical manufacturers and contract development organizations as a controlled API for finished dosage form production. The primary commercial application is in the manufacture of oral solid dosage forms.

These include tablets and film-coated tablets for erectile dysfunction treatment, where it functions as the active ingredient at defined therapeutic concentrations. Revatio-branded formulations target pulmonary arterial hypertension.

This represents a distinct regulatory and manufacturing pathway that requires separate product specifications. Generic drug manufacturers across regulated markets source the material as a bulk API to produce bioequivalent products.

These products are measured against established reference listed drugs. Contract manufacturers also use it in suspension formulations for pediatric pulmonary hypertension indications to meet specific patient needs.

The material is supplied as a white to off-white crystalline powder in bulk quantities suited to pharmaceutical-scale production. It is available to USP and EP ( Ph. Eur. ) grade specifications.

These are the standard requirements for regulated market submissions. Sourcing typically requires compliance documentation including CoA, DMF references, and GMP certification from the manufacturing site.

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Physical Properties

Melting Point196.5 °C
AppearanceWhite Solid
ColorWhite
Formwhite powder
Water Solubility3.488g/L(temperature not stated)

Safety & Handling

Warning GHS07 Hazard Statements H302 Harmful if swallowed H315 Causes skin irritation H319 Causes serious eye irritation H320 Causes eye irritation H335 May cause respiratory irritation H412 Harmful to aquatic life with long lasting effects Precautionary Statements P261 Avoid breathing dust/fume/gas/mist/vapours/spray. P264 Wash … thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P271 Use only outdoors or in a well-ventilated area. P273 Avoid release to the environment. P280 Wear protective gloves/protective clothing/eye protection/face protection. P319 Get medical advice/attention if you feel unwell. P321 Specific treatment (see … on this label). P330 Rinse mouth. P405 Store locked up. P501 Dispose of contents/container in accordance with local regulations. P264+P265 Wash … thoroughly after handling. P301+P317 Get emergency medical help. P302+P352 IF ON SKIN: Wash with plenty of water. P304+P340 IF INHALED: Remove person to fresh air and keep comfortable for breathing. P332+P317 Get emergency medical help. P337+P317 If eye irritation persists: Get medical advice/attention. Get emergency medical help. P362+P364 Take off contaminated clothing and wash it before reuse. P403+P233 Store in a well-ventilated place. Keep container tightly closed. P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

Trade & Regulatory

HS Code2933595960
Storage Class11 - Combustible Solids
WGK (Germany)3

Other Names

Revatio | VIAGRA | Caverta | LIQREV | Sildenafil (as citrate) | BW9B0ZE037

Related Products

Chemical Properties

CAS Number
171599-83-0
EC Number
638-824-3
Mol. Weight
666.7
HS Code
2933595960

Industries

Documentation