Prasugrel Hydrochloride is a pharmaceutical active ingredient belonging to the thienopyridine class of antiplatelet agents. It is the hydrochloride salt of prasugrel and is used in the manufacture of pharmaceutical formulations designed to inhibit platelet aggregation and reduce thrombotic cardiovascular events.
The exact pharmaceutical substance is Prasugrel Hydrochloride, with the molecular formula C₂₀H₂₀FNO₃S·HCl and molecular weight 409.90 g/mol. The USP monograph identifies 389574-19-0 as the CAS number for Prasugrel Hydrochloride, while 150322-43-3 corresponds to the prasugrel free base.
Prasugrel is a prodrug that is metabolically converted to its active metabolite, which irreversibly inhibits the platelet P2Y12 ADP receptor. This inhibits ADP-mediated platelet activation and aggregation. Prasugrel is therefore an important API for antiplatelet pharmaceutical products.
The hydrochloride salt is a well-defined pharmaceutical form with established USP quality requirements. The USP definition specifies NLT 97.0% and NMT 102.0% Prasugrel Hydrochloride, calculated on the anhydrous and solvent-free basis.
Product Name: Prasugrel Hydrochloride
Pharmaceutical Form: Prasugrel Hydrochloride
CAS Number: 389574-19-0
Alternate CAS: 150322-43-3 — Prasugrel free base
Molecular Formula: C₂₀H₂₀FNO₃S·HCl
Molecular Weight: 409.90 g/mol
Active Moiety: Prasugrel
Free-Base Molecular Weight: 373.44 g/mol
Class: Thienopyridine antiplatelet API
Physical Form: White to off-white crystalline/powder material
PubChem confirms the hydrochloride formula and molecular weight of 409.9 g/mol and identifies CAS 389574-19-0 for the hydrochloride salt.
Prasugrel Hydrochloride contains a thienopyridine ring system, fluorophenyl group and cyclopropyl-containing ketone structure. The API is supplied as the hydrochloride salt rather than the free base for pharmaceutical use.
Prasugrel is a chiral compound with an undefined stereocenter in the chemical database representation. Consequently, stereochemical control and impurity profiling are important aspects of API quality.
The substance is described as a solid, and available pharmaceutical references describe Prasugrel Hydrochloride as white to practically white material. It is freely soluble in methanol and has limited water solubility, with solubility dependent on pH.
Prasugrel Hydrochloride API is used for the manufacture of antiplatelet medicines. Prasugrel inhibits platelet activation through irreversible antagonism of the P2Y12 ADP receptor after metabolic activation. This pharmacological action reduces platelet aggregation and is relevant to patients with acute coronary syndromes undergoing percutaneous coronary intervention.
Prasugrel Hydrochloride has a specific USP monograph covering identity, assay and impurity control. The USP assay is performed on an anhydrous and solvent-free basis, with an acceptance range of 97.0–102.0%.
Pharmaceutical analytical evaluation can include identification by spectroscopic and chromatographic methods, assay by HPLC and related-substance analysis.
A USP monograph evaluation report provides detailed impurity controls including specified impurities such as desacetyl prasugrel diastereomers, prasugrel chlorobutyryl analog and prasugrel diketone. The report gives a total impurity limit of NMT 1.0% and an unspecified individual impurity limit of NMT 0.10% for the evaluated USP method.
Prasugrel Hydrochloride manufacturing requires controlled synthesis, purification, hydrochloride salt formation and crystallization. Particular attention should be given to chemical purity, stereochemical quality, residual solvents and degradation-related impurities.
A pharmaceutical-grade API specification should be supported by batch-specific analytical data rather than relying on generic specifications used for unrelated thienopyridine APIs.
For pharmaceutical customers, documentation can include a Certificate of Analysis, specification sheet, analytical methods, impurity profile, residual-solvent information and other quality documentation according to the intended regulatory market.
Prasugrel Hydrochloride should be stored in a suitable tightly closed pharmaceutical container and protected from conditions that could adversely affect its chemical stability.
Commercial analytical material is commonly recommended for storage at controlled low temperature; one current specification lists −20°C as the recommended storage temperature. This should not automatically be treated as a universal pharmaceutical API storage requirement; the final storage condition should follow the validated stability program and approved specification.
Prasugrel Hydrochloride API documentation may include:
Prasugrel Hydrochloride is an established antiplatelet API with a dedicated USP monograph and defined quality requirements. Accurate control of assay, related substances, stereochemical quality, residual solvents and physical characteristics is important for consistent pharmaceutical manufacturing.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.10% |
| Individual Impurity | NMT 0.10% |