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 pharmaceutical formulations intended to inhibit platelet activation and aggregation.
The exact API form is Prasugrel Hydrochloride, with CAS Number 389574-19-0, molecular formula C₂₀H₂₁ClFNO₃S, and molecular weight 409.90 g/mol. PubChem and FDA-associated substance records distinguish Prasugrel Hydrochloride from the free-base Prasugrel, which has CAS 150322-43-3 and molecular weight 373.4 g/mol.
Prasugrel is a prodrug that undergoes metabolic activation to form an active metabolite that irreversibly inhibits the platelet P2Y12 ADP receptor. This reduces ADP-mediated platelet activation and aggregation. Prasugrel is therefore used as an antiplatelet pharmaceutical ingredient in cardiovascular medicine.
Prasugrel Hydrochloride is particularly relevant to pharmaceutical products used in patients with acute coronary syndromes and in patients undergoing percutaneous coronary intervention.
Product Name: Prasugrel Hydrochloride
Pharmaceutical Form: Prasugrel Hydrochloride
CAS Number: 389574-19-0
Alternate CAS: 150322-43-3 — Prasugrel free base
Molecular Formula: C₂₀H₂₁ClFNO₃S
Molecular Weight: 409.90 g/mol
Active Moiety: Prasugrel
Class: Thienopyridine antiplatelet API
Physical Form: White to practically white solid
PubChem identifies 389574-19-0 as the CAS number for Prasugrel Hydrochloride and confirms its molecular formula and molecular weight.
Prasugrel Hydrochloride contains a thienopyridine structure with a fluorophenyl group, cyclopropyl ketone moiety and acetate functionality. The hydrochloride salt consists of prasugrel and hydrochloric acid in a 1:1 salt relationship.
The free base should not be confused with the pharmaceutical hydrochloride form. Prasugrel free base = CAS 150322-43-3, whereas Prasugrel Hydrochloride = CAS 389574-19-0. This distinction is important for API specifications, regulatory documents, CoAs and product-page SEO.
Prasugrel Hydrochloride is described as a white to practically white solid. It is freely soluble in methanol, while its aqueous solubility varies significantly with pH; it is more soluble under acidic conditions and practically insoluble around neutral pH.
Prasugrel Hydrochloride API is used for manufacturing antiplatelet pharmaceutical products. Following metabolic activation, prasugrel's active metabolite irreversibly binds to P2Y12 receptors on platelets, inhibiting ADP-induced platelet activation and aggregation.
Its pharmaceutical application is primarily associated with the prevention of thrombotic cardiovascular events in appropriate patients with acute coronary syndromes, particularly those undergoing PCI.
Quality control of Prasugrel Hydrochloride should include API identification, assay, related substances, residual solvents, water/moisture and inorganic residue testing where required by the applicable specification.
The USP monograph defines Prasugrel Hydrochloride at 97.0–102.0%, calculated on an anhydrous and solvent-free basis. This basis is important and should be retained when displaying the assay in a pharmaceutical CMS.
Related-substance testing is also important because prasugrel can generate process-related and degradation-related impurities. Individual impurity limits should therefore be based on the applicable current pharmacopoeial method or approved API specification rather than generic limits used for unrelated APIs.
Manufacturing Prasugrel Hydrochloride requires controlled synthesis, purification and hydrochloride salt formation followed by controlled crystallization and drying. Particular attention should be given to chemical purity, stereochemical quality, related substances and residual solvents.
A pharmaceutical-grade manufacturing process should be supported by validated analytical methods and batch-specific testing. Quality documentation can include Certificate of Analysis, specifications, analytical chromatograms, impurity profiles, residual-solvent information and stability data according to customer and regulatory requirements.
Prasugrel Hydrochloride should be packaged in suitable well-closed pharmaceutical containers and protected from moisture, excessive heat and conditions that could adversely affect stability.
Storage conditions should ultimately be established from the validated stability program for the specific API, packaging configuration and intended regulatory market rather than copying a research-material storage condition.
Typical documentation may include:
Prasugrel Hydrochloride is a well-characterized antiplatelet API with an established pharmaceutical application and pharmacopoeial quality requirements. Consistent control of assay, related substances, stereochemical quality, moisture and residual solvents supports reliable API quality for pharmaceutical manufacturing.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Residue on Ignition | NMT 0.10% |
| Individual Impurity | NMT 0.10% |
| Total Impurities | NMT 1.0% |