Description

Prasugrel Impurity 14 Maleate is a high-purity reference standard critical for analytical and regulatory purposes in pharmaceutical development and quality control. This compound is essential for the accurate identification, quantification, and monitoring of a specific impurity during the manufacturing and stability testing of the antiplatelet drug Prasugrel. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory affairs departments to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards such as USP and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the quantitative and qualitative analysis of Prasugrel drug substance and finished products.
• Method Development and Validation: Used in developing and validating stability-indicating HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control (QC) Testing: Employed in routine batch release testing to ensure impurity levels are within specified ICH limits.
• Stability Studies: Critical for monitoring the formation and growth of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research and Development: Used in R&D to understand impurity formation pathways and to develop purification processes for the active pharmaceutical ingredient (API).

Basic Information

Product Name	Prasugrel Impurity 14 Maleate
CAS No.	1373350-60-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Prasugrel Related Compound 14 Maleate; Prasugrel Maleate Impurity 14; 5-[2-Cyclopropyl-1-(2-fluorophenyl)-2-oxoethyl]-4,5,6,7-tetrahydrothieno[3,2-c]pyridin-2-yl acetate maleate; Effient Impurity 14 Maleate; (R)-Prasugrel Impurity 14 Maleate; Prasugrel EP Impurity H Maleate; Prasugrel USP Impurity 14 Maleate
EINECS	Contact for details

Quality Control

Every batch of Prasugrel Impurity 14 Maleate is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with industry standards and customer specifications for use as a reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile. We support compliance with ICH Q3A, Q3B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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