Description

Diltiazem Impurity 4 (CAS NO 132830-17-2) is a high-purity chemical reference standard critical for ensuring the quality and safety of the cardiovascular drug Diltiazem HCl. This compound is essential for pharmaceutical research, development, and quality control laboratories to accurately identify, quantify, and monitor this specific impurity during the manufacturing process. It is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical industry for method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments and validation of testing methods.
• Method Development and Validation (HPLC/LC-MS): Used to develop, optimize, and validate chromatographic methods for impurity profiling of Diltiazem API and finished dosage forms.
• Quality Control and Batch Release: Critical for the quantitative analysis of Diltiazem Impurity 4 in active pharmaceutical ingredients (API) to ensure compliance with pharmacopeial limits (e.g., USP, EP).
• Stability Studies: Employed to track the formation and level of this impurity over time under various storage conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate control over the impurity profile of the drug substance.
• Research and Development: Used in synthetic chemistry R&D to understand and mitigate the formation pathways of this impurity during the manufacturing process.

Basic Information

Item	Detail
Product Name	Diltiazem Impurity 4
CAS No.	132830-17-2
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 D; Diltiazem EP Impurity D; Diltiazem USP Impurity D; Diltiazem Hydrochloride Impurity 4; 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, (2S,3S)-
EINECS	Contact for details

Quality Control

Every batch of Diltiazem Impurity 4 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

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 must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an 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.