Description

Clopidogrel Bisulfate Impurity P 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 active pharmaceutical ingredient (API) clopidogrel bisulfate, a widely prescribed antiplatelet medication. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in method development, validation, and quality control testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in clopidogrel bisulfate API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation of degradation products during forced degradation and long-term stability studies of clopidogrel formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Facilitates studies on the synthesis, characterization, and toxicological assessment of clopidogrel-related compounds.

Basic Information

Product Name	Clopidogrel Bisulfate Impurity P
CAS No.	2418591-12-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Clopidogrel Related Compound P; Clopidogrel Bisulfate Related Substance P; Clopidogrel Impurity P; Clopidogrel Sulfate Impurity P; (S)-Methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate sulfate impurity; Clopidogrel Process Impurity P
EINECS	Contact for details

Quality Control

Our Clopidogrel Bisulfate Impurity P is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis and spectroscopic characterization (NMR, MS), to ensure identity, strength, and composition. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your quality and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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