Description

Prasugrel Impurity Iii CAS NO 1391194-50-5 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antiplatelet drug Prasugrel by serving as a key marker for impurity profiling and control. It is an essential material for pharmaceutical R&D laboratories, quality control units, and regulatory bodies involved in the development and manufacturing of generic and branded Prasugrel formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Prasugrel active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity levels in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance: Used in routine QC testing to ensure batch-to-batch consistency and that impurity levels remain within specified safety thresholds.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive characterization data for impurity profiles.
• Stability Studies: Employed to track the formation of degradation products in Prasugrel under various stress conditions (e.g., heat, humidity, light).
• Pharmacopoeial Standards: Serves as a potential impurity standard for inclusion in pharmacopoeial monographs (USP, EP, JP).

Basic Information

Product Name	Prasugrel Impurity Iii
CAS No.	1391194-50-5
Molecular Formula	C20H20FNO3S
Molecular Weight	373.44 g/mol
Synonyms	Prasugrel Related Compound III; Prasugrel Impurity 3; 5-[2-Cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate; (RS)-5-[2-Cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,7-dihydro-5H-thieno[3,2-c]pyridin-2-yl acetate; Prasugrel EP Impurity C; Prasugrel USP Impurity III
EINECS	Contact for details

Quality Control

Every batch of Prasugrel Impurity Iii is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) are provided, detailing results from advanced analytical techniques including HPLC, GC, MS, and NMR. We support compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The material is light-sensitive (store away from light). For long-term storage, consider storing desiccated under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.