Description

n-Monodemethyldiltiazem is a key pharmaceutical intermediate and metabolite of the calcium channel blocker diltiazem. This compound is of significant importance for research and development in cardiovascular pharmacology and drug metabolism studies. It is primarily utilized by pharmaceutical manufacturers and analytical laboratories for the synthesis of novel therapeutic agents and as a reference standard in bioanalytical testing.

Application

• Pharmaceutical Intermediate: Critical building block in the synthesis of diltiazem analogs and related cardiovascular drugs.
• Metabolite Reference Standard: Used as a certified reference material (CRM) in pharmacokinetic and bioequivalence studies for diltiazem.
• Analytical Research: Serves as a high-purity standard for method development and validation in HPLC, LC-MS, and other chromatographic techniques.
• Biochemical Research: Employed in studies investigating the metabolic pathways and enzymatic interactions of benzothiazepine derivatives.
• Quality Control: Essential for impurity profiling and ensuring the purity of bulk diltiazem API (Active Pharmaceutical Ingredient) in GMP manufacturing.

Basic Information

Product Name	n-Monodemethyldiltiazem
CAS No.	85100-17-0
Molecular Formula	C21H26N2O4S
Molecular Weight	402.51 g/mol
Synonyms	Desmethyldiltiazem; N-Desmethyldiltiazem; Diltiazem Metabolite M1; 3-(Acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one; (+)-cis-3-Acetoxy-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one; MA (Metabolite A); BAY a 1040 Metabolite
EINECS	Contact for details

Quality Control

Our n-Monodemethyldiltiazem is produced under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for pharmaceutical research and development. Certificates of Analysis (COA) with detailed chromatographic data are provided for every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Single Maximum Impurity	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 0.5%

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