Description

Deacetyl-o-Demethyl Diltiazem Hydrochloride is a key pharmaceutical intermediate and reference standard used in the synthesis and analytical verification of cardiovascular drugs. This compound is critical for ensuring the quality, purity, and consistency of active pharmaceutical ingredients (APIs) derived from the diltiazem chemical pathway. It is primarily required by pharmaceutical manufacturers, research institutions, and quality control laboratories engaged in the development and production of calcium channel blockers and related therapeutic agents.

Application

• Pharmaceutical Intermediate: A crucial building block in the multi-step synthesis of diltiazem hydrochloride and its structural analogs.
• Reference Standard: Used as a certified reference material (CRM) for identity confirmation and purity assessment in analytical methods like HPLC and LC-MS.
• Process Development & Validation: Essential for research and development (R&D) scientists optimizing synthetic routes and scaling up production processes.
• Quality Control & Assurance: Employed in in-house laboratory testing to verify the specifications of raw materials and finished APIs against pharmacopeial standards.
• Metabolite Studies: Used in pharmacological and pharmacokinetic research to study drug metabolism pathways.
• Regulatory Submissions: Serves as a characterized impurity or intermediate standard in regulatory documentation for drug approval (e.g., FDA, EMA).

Basic Information

Product Name	Deacetyl-o-Demethyl Diltiazem Hydrochloride
CAS No.	96252-32-3
Molecular Formula	C20H26N2O4S • HCl
Molecular Weight	426.96 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 hydrochloride; Desacetyl desmethyl diltiazem HCl; Diltiazem Impurity G (Hydrochloride); Diltiazem Related Compound G; 3-Acetoxy-5-[2-(dimethylamino)ethyl]-2-(4-methoxyphenyl)-2,3-dihydro-1,5-benzothiazepin-4(5H)-one hydrochloride
EINECS	Contact for details

Quality Control

Our Deacetyl-o-Demethyl Diltiazem Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and NMR, and residual solvent analysis, to ensure it meets stringent specifications for pharmaceutical use. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
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.