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Pharmaceutical Intermediates

Tadalafil

CAS: 171596-29-5

Overview

Tadalafil (CAS 171596-29-5 ), also referenced in development literature as IC351, is a PDE5 inhibitor active pharmaceutical ingredient used in the treatment of erectile dysfunction and pulmonary arterial hypertension.

It functions as the pharmacologically active component in finished oral dosage forms and is sourced by formulators and importers as a bulk API or pharmaceutical intermediate for various industrial applications.

In prescription drug manufacturing, the compound is formulated into film-coated tablets at defined dosage strengths for both on-demand and daily-use therapeutic regimens across global markets.

Compounding pharmacies source the bulk API to prepare customized dosage forms for patients with specific clinical requirements. This ensures flexibility in treatment options for diverse patient populations.

Pulmonary arterial hypertension treatments represent a distinct therapeutic segment, where the ingredient is incorporated into once-daily oral formulations targeting vascular smooth muscle relaxation and improved blood flow.

Research and analytical laboratories also procure it as a reference standard or intermediate for method development and quality control testing to ensure the safety and efficacy of final products.

The substance is supplied as a white to off-white crystalline powder. It is available in API-grade quality aligned with USP and EP monograph specifications, which are the primary benchmarks required.

Bulk quantities are typically offered in kilogram-scale packaging, with documentation including CoA, impurity profiles, and relevant DMF references to support regulatory compliance and manufacturing standards.

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Physical Properties

Melting Point303.2 °C
Boiling Point679.1±55.0 °C(Predicted)
Density1.51±0.1 g/cm3(Predicted)
Flash Point2°C
AppearanceWhite to Off-White Cyrstalline Solid
Colorwhite to beige
Formpowder

Safety & Handling

Warning GHS07 Hazard Statements H302 Harmful if swallowed H312 Harmful in contact with skin H315 Causes skin irritation H319 Causes serious eye irritation H332 Harmful if inhaled H335 May cause respiratory irritation 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. P280 Wear protective gloves/protective clothing/eye protection/face protection. P317 Get emergency medical help. 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 Code2934990002
WGK (Germany)3

Other Names

Tadanafil | ICOS 351 | IC351 | Cialis® | Adcirca® | Tadalafil mylan | Trans-tadalafil

Related Products

Chemical Properties

CAS Number
171596-29-5
EC Number
687-782-2
Mol. Weight
389.4
HS Code
2934990002

Industries

Documentation