Description

Ranitidine-N,S-Dioxide is a key pharmaceutical intermediate and analytical reference standard, primarily used in the research and development of active pharmaceutical ingredients (APIs). This compound is critical for quality control processes, impurity profiling, and metabolic studies related to ranitidine-based therapeutics. It serves the needs of pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories requiring high-purity chemical standards for method development and validation.

Application

• Pharmaceutical Intermediate: Synthesis of ranitidine and related histamine H2-receptor antagonist compounds.
• Analytical Reference Standard: Used as a certified reference material (CRM) for HPLC, LC-MS, and other chromatographic methods in quality control labs.
• Impurity Profiling: Critical for identifying and quantifying process-related impurities and degradation products in ranitidine API and finished drug products.
• Metabolite Studies: Employed in pharmacological and toxicological research to study the metabolic pathways of ranitidine.
• Method Development & Validation: Serves as a standard for developing and validating stability-indicating analytical methods per ICH guidelines.
• Regulatory Compliance: Supports regulatory filings (e.g., FDA, EMA) by providing necessary impurity data for drug master files (DMFs).

Basic Information

Product Name	Ranitidine-N,S-Dioxide
CAS No.	1185237-42-6
Molecular Formula	C13H22N4O4S
Molecular Weight	330.40 g/mol
Synonyms	Ranitidine N-Oxide Sulfoxide; Ranitidine Sulfoxide N-Oxide; N-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine S-Oxide N-Oxide; Ranitidine Impurity; Ranitidine Related Compound; Zantac Impurity; 1,1-Ethenediamine, N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]sulfinyl]ethyl]-N'-methyl-2-nitro-, N-oxide
EINECS	Contact for details

Quality Control

Our Ranitidine-N,S-Dioxide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identification by spectroscopic methods (IR, NMR), and control of related substances. We provide full traceability and Certificates of Analysis (COA) detailing all test results, ensuring compliance with the stringent requirements of pharmaceutical R&D and quality control applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

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% Any single unknown impurity ≤ 0.5%
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.