Description

Sarpogrelate Impurity CAS NO 1140968-46-2 is a high-purity chemical reference standard used in the research, development, and quality control of the active pharmaceutical ingredient (API) Sarpogrelate. This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of pharmaceutical products by enabling accurate identification and quantification of related substances. It is an essential material for analytical laboratories, pharmaceutical manufacturers, and regulatory bodies focused on cardiovascular drug development and quality assurance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Sarpogrelate API and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and other chromatographic methods in quality control laboratories.
• Stability Studies & Forced Degradation: Used to monitor impurity profiles and assess the stability of Sarpogrelate under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA, CMC sections) by providing necessary impurity data for health authorities like the FDA and EMA.
• Pharmacopoeial Testing: Employed in testing to meet the specifications outlined in pharmacopoeias such as USP, EP, or JP.
• Process Chemistry & Impurity Profiling: Aids in the identification of process-related impurities during the synthesis and scale-up of Sarpogrelate.

Basic Information

Product Name	Sarpogrelate Impurity
CAS No.	1140968-46-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sarpogrelate Related Compound; Sarpogrelate Impurity Standard; Sarpogrelate Process Impurity; Sarpogrelate Degradant; 2-[2-Methoxy-4-(1-methyl-1H-indol-5-yloxy)phenylsulfonyl]ethanol (related compound); 5-[2-Methoxy-4-[(2-hydroxyethyl)sulfonyl]phenoxy]-1-methyl-1H-indole (related compound); Sarpogrelate Hydroxyethyl Sulfone Impurity; Sarpogrelate EP Impurity
EINECS	Contact for details

Quality Control

Our Sarpogrelate Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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