Description

Ranitidine-n-Oxide is a key pharmaceutical intermediate and metabolite of the widely used H2-receptor antagonist, ranitidine. This compound is of significant importance for research and development in pharmacology and analytical chemistry, particularly in studies related to drug metabolism, pharmacokinetics, and impurity profiling. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and academic institutions engaged in advanced drug development and quality control processes.

Application

• Pharmaceutical Intermediate: Critical synthesis component for the development and production of ranitidine and related therapeutic agents.
• Metabolite Reference Standard: Essential for use as a certified reference material (CRM) in bioanalytical studies to understand drug metabolism and excretion pathways.
• Impurity Profiling: Used as a known impurity standard in HPLC and LC-MS methods to ensure the purity and safety of ranitidine API and finished dosage forms.
• Pharmacological Research: Serves as a tool compound in preclinical and clinical research to investigate the pharmacological activity and safety profile of ranitidine metabolites.
• Quality Control & Assurance: Employed in analytical laboratories for method development, validation, and routine testing to comply with ICH and pharmacopeial guidelines.

Basic Information

Product Name	Ranitidine-n-Oxide
CAS No.	73857-20-2
Molecular Formula	C13H22N4O4S
Molecular Weight	330.40 g/mol
Synonyms	Ranitidine N-Oxide; Ranitidine N-Oxyde; N-Oxide Ranitidine; Ranitidine Impurity F (EP); Ranitidine Related Compound F (USP); 1,1-Dimethyl-2-[(5-[(dimethylamino)methyl]-2-furanyl)methylthio]ethylamine N-Oxide; Zantac N-Oxide; N-Oxide of N-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine
EINECS	Contact for details

Quality Control

Our Ranitidine-n-Oxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via IR and MS, to ensure it meets high-purity standards suitable for research and reference applications. Certificates of Analysis (COA) with detailed chromatographic data are provided to support regulatory submissions and internal quality assurance protocols.

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 corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.