Description

Diltiazem Impurity 5 is a specified impurity and degradation product of the calcium channel blocker Diltiazem, identified by the CAS registry number 91926-66-8. This compound is critical for pharmaceutical research and development, serving as a key reference standard for ensuring the purity, safety, and efficacy of Diltiazem-based drug products. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, particularly those involved in method development, stability studies, and regulatory compliance for cardiovascular medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Diltiazem Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Critical for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to monitor impurity profiles.
• Stability and Forced Degradation Studies: Used to understand the degradation pathways of Diltiazem and to establish appropriate shelf-life and storage conditions for drug products.
• Quality Control and Batch Release Testing: Essential for routine QC testing to ensure batches of Diltiazem API and formulations meet stringent pharmacopeial (USP, EP, JP) and ICH regulatory guidelines for impurity limits.
• Regulatory Documentation and Submissions: Supports the preparation of regulatory filings (e.g., CMC sections for FDA, EMA) by providing definitive characterization data for specified impurities.
• Research on Drug Metabolism and Pharmacokinetics (DMPK): Can be utilized as a marker or intermediate in studies investigating the metabolic fate of Diltiazem.

Basic Information

Product Name	Diltiazem Impurity 5
CAS No.	91926-66-8
Molecular Formula	C22H26N2O4S
Molecular Weight	414.52 g/mol
Synonyms	(2S,3S)-5-[2-(Dimethylamino)ethyl]-2-(4-methoxyphenyl)-4-oxo-2,3,4,5-tetrahydro-1,5-benzothiazepin-3-yl acetate; Diltiazem Acetyl Impurity; Diltiazem Related Compound E; Diltiazem EP Impurity E; 3-Acetoxy-2,3-dihydro-5-[2-(dimethylamino)ethyl]-2-(p-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one; Diltiazem Impurity E
EINECS	Contact for details

Quality Control

Every batch of Diltiazem Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for appearance, identification (HPLC, IR), assay (by HPLC), and related substances. We support compliance with ICH Q3A/B, 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); ensure the container is kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% 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.