Description

Diltiazem Hydrochloride is a high-purity pharmaceutical active ingredient belonging to the class of calcium channel blockers. This compound is critical for the formulation of cardiovascular medications used to manage hypertension and angina. It is essential for pharmaceutical manufacturers and research institutions developing controlled-release and immediate-release dosage forms. Our product is supplied to meet the stringent requirements of global pharmacopoeial standards.

Application

• Primary Active Pharmaceutical Ingredient (API) in antihypertensive medications.
• Key component in the formulation of anti-anginal drugs.
• Used in the development and production of extended-release tablets and capsules.
• Critical raw material for generic pharmaceutical manufacturers.
• Reference standard in analytical and quality control laboratories.
• Starting material for further chemical synthesis in advanced pharmaceutical research.
• Used in clinical trial material (CTM) manufacturing.

Basic Information

Product Name	Diltiazem Hydrochloride
CAS No.	33286-22-5
Molecular Formula	C22H26N2O4S • HCl
Molecular Weight	450.98 g/mol
Synonyms	Diltiazem HCl; (2S,3S)-5-[2-(Dimethylamino)ethyl]-2-(4-methoxyphenyl)-4-oxo-2,3,4,5-tetrahydro-1,5-benzothiazepin-3-yl acetate hydrochloride; 3-(Acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one hydrochloride; Herbesser; Cardizem; Tiazac; Altiazem; Dilacor
EINECS	Contact for details

Quality Control

Our Diltiazem Hydrochloride is manufactured under strict quality management systems. Each batch is tested to ensure compliance with major pharmacopoeial standards such as USP, EP, and JP. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing parameters including assay, related substances, residual solvents, and microbiological quality. We ensure traceability and batch-to-batch consistency for our global pharmaceutical partners.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White or almost white, crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.5% - 101.5% (on anhydrous basis)
Related Substances (HPLC)	Total impurities: NMT 1.0% Any individual impurity: NMT 0.5%
Water (KF Titration)	NMT 1.0%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm
Microbiological Enumeration	Meets Ph. Eur. requirements

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