Description

Diltiazem Impurity 8 CAS NO 86408-42-6 is a specified impurity of the calcium channel blocker Diltiazem Hydrochloride, used in pharmaceutical research and development. This compound is critical for analytical method development, stability studies, and ensuring the quality and safety of the final drug product. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory affairs professionals involved in the production and validation of Diltiazem-based medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Diltiazem Hydrochloride and related drug substances.
• Method Development and Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to accurately identify and quantify this specific impurity.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor impurity profiles and establish shelf-life for Diltiazem formulations.
• Quality Control & Batch Release: Serves as a system suitability standard in the routine QC testing of active pharmaceutical ingredients (APIs) and finished drug products to ensure compliance with pharmacopeial limits.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies.
• Research and Synthesis: Used in chemical research to study degradation pathways and to synthesize or purify Diltiazem and related compounds.

Basic Information

Item	Detail
Product Name	Diltiazem Impurity 8
CAS No.	86408-42-6
Molecular Formula	C22H26N2O4S
Molecular Weight	414.52 g/mol
Synonyms	(2S,3S)-3-Acetoxy-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one; Diltiazem Related Compound H; Diltiazem EP Impurity H; Diltiazem USP Related Compound H; Diltiazem Hydrochloride Impurity 8; 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, (2S,3S)-; Diltiazem Acetyl Derivative
EINECS	Contact for details

Quality Control

Every batch of Diltiazem Impurity 8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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