Description

Diltiazem Ep Impurity B CAS NO 87447-47-0 is a high-purity reference standard used for the analytical profiling and quality control of the cardiovascular drug Diltiazem Hydrochloride. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards such as the European Pharmacopoeia (EP). It is primarily utilized in research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Diltiazem Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) in quality control laboratories.
• Critical component in stability studies and forced degradation studies to monitor impurity profiles over time.
• Used for pharmacopeial compliance testing, specifically for meeting European Pharmacopoeia (EP) and other international regulatory specifications.
• Supports research and development of new synthetic routes and purification processes for Diltiazem.
• Employed in regulatory submissions (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.

Basic Information

Product Name	Diltiazem Ep Impurity B
CAS No.	87447-47-0
Molecular Formula	C22H26N2O4S
Molecular Weight	414.52 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; Diltiazem Impurity B (EP); Diltiazem Related Compound B; Diltiazem Acetyl Impurity; 3-Acetoxy-2,3-dihydro-5-[2-(dimethylamino)ethyl]-2-(p-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one; 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-, (2S,3S)-; Diltiazem EP Impurity B
EINECS	Contact for details

Quality Control

Our Diltiazem Ep Impurity B is manufactured under strict quality systems to ensure it meets the highest standards for use as a reference material. Each batch undergoes comprehensive analytical testing, including HPLC purity determination, identity confirmation by spectroscopic methods (IR, NMR, MS), and control of related substances. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data and traceability information. Our quality commitment aligns with the requirements of cGMP for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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