Description

o-Desacetyl-n-Desmethyl Diltiazem is a key pharmaceutical intermediate and metabolite of the calcium channel blocker diltiazem. This compound is of significant importance for analytical and research purposes, particularly in the development and quality control of cardiovascular drugs. It is primarily required by pharmaceutical R&D laboratories, contract manufacturing organizations (CMOs), and analytical service providers for use as a reference standard and in metabolic studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of diltiazem and its related substances in drug substances and finished products.
• Metabolite Studies: Critical for in-vitro and in-vivo pharmacokinetic and pharmacodynamic research to understand the metabolic pathway of diltiazem.
• Impurity Profiling: Employed in the identification and quantification of process-related impurities and degradation products during drug development and stability testing.
• Method Development & Validation: Serves as a critical component in developing and validating analytical methods, such as HPLC and LC-MS/MS, for regulatory submissions.
• Bioequivalence Testing: Used in studies to compare the metabolic profiles of generic diltiazem formulations against the innovator product.

Basic Information

Product Name	o-Desacetyl-n-Desmethyl Diltiazem
CAS No.	81353-09-5
Molecular Formula	C20H24N2O4S
Molecular Weight	388.48 g/mol
Synonyms	Diltiazem Impurity G; Diltiazem Related Compound G; Desacetyldesmethyldiltiazem; 5-[2-(Dimethylamino)ethyl]-2,3,4,5-tetrahydro-2-(4-methoxyphenyl)-4-thioxo-1,5-benzothiazepin-3-yl acetate (deprotected form); Diltiazem Metabolite; D 888; (2S,3S)-5-[2-(Dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-4-thioxo-1,5-benzothiazepin-3-yl alcohol
EINECS	Contact for details

Quality Control

Our o-Desacetyl-n-Desmethyl Diltiazem is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5%

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