Description

Diltiazem Ep Impurity C is a high-purity reference standard specifically identified as a process-related impurity of the cardiovascular drug Diltiazem Hydrochloride. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing, ensuring the safety and efficacy of the final drug product. It is an essential material for research and quality assurance laboratories in the global pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Diltiazem-related impurities.
• Analytical Method Development: Used to develop and validate HPLC, UPLC, and GC methods for impurity profiling in active pharmaceutical ingredient (API) batches.
• Quality Control & Assurance: Critical for routine testing in pharmaceutical QC labs to monitor impurity levels against ICH Q3A/B guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data for Drug Master Files (DMFs).
• Stability Studies: Employed as a marker to track impurity formation during forced degradation and long-term stability testing of Diltiazem formulations.
• Research & Synthesis: Serves as an intermediate or marker in process chemistry research to optimize synthesis pathways and reduce impurity formation.

Basic Information

Product Name	Diltiazem Ep Impurity C
CAS No.	1286126-67-7
Molecular Formula	C22H26N2O4S
Molecular Weight	414.52 g/mol
Synonyms	(2S,3S)-5-[2-(Dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-4-methyl-3-(phenylsulfonyl)-1,5-benzothiazepin-4(5H)-one; Diltiazem EP Impurity C; Diltiazem Related Compound C; Diltiazem Sulfone Impurity; 1,5-Benzothiazepin-4(5H)-one, 5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-4-methyl-3-(phenylsulfonyl)-, (2S,3S)-
EINECS	Contact for details

Quality Control

Our Diltiazem Ep Impurity C is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, MS, and NMR to confirm identity and purity. A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical methods is provided with every shipment, supporting compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
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.