Description

Diltiazem Impurity 3 is a specified impurity of the calcium channel blocker Diltiazem Hydrochloride, a critical pharmaceutical active ingredient. This high-purity reference standard is essential for analytical method development, validation, and quality control in pharmaceutical manufacturing and research. It is primarily used by pharmaceutical R&D laboratories, quality assurance/control (QA/QC) departments, and contract research organizations (CROs) to ensure the safety, efficacy, and regulatory compliance of Diltiazem-based drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the identification and quantification of Diltiazem Impurity 3 in drug substances and finished products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or GC methods to monitor impurities in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: Used in routine QA/QC testing to ensure Diltiazem Hydrochloride and its formulations meet stringent pharmacopeial (USP, EP, JP) purity specifications.
• Stability Studies & Forced Degradation: Employed to identify and track degradation products formed during stability testing of Diltiazem under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary impurity characterization data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Diltiazem to minimize the formation of this specific impurity.

Basic Information

Product Name	Diltiazem Impurity 3
CAS No.	86408-44-8
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 C; Diltiazem EP Impurity C; Diltiazem USP Related Compound C; Diltiazem Hydrochloride Impurity 3; 3-Acetyl Diltiazem; trans-(+)-3-Acetoxy-2,3-dihydro-5-[2-(dimethylamino)ethyl]-2-(p-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one
EINECS	Contact for details

Quality Control

Our Diltiazem Impurity 3 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identification by spectroscopic methods (IR, NMR, MS), and control of related substances, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

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 impurity ≤ 0.5%
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.