Description

Nizatidine Sulfoxide is a key pharmaceutical intermediate and metabolite of the H₂-receptor antagonist nizatidine. This compound is of significant importance for research and development in analytical chemistry and pharmacology, particularly for method development, impurity profiling, and metabolic studies. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and academic institutions engaged in drug development and quality control.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of nizatidine and its related substances in drug products and active pharmaceutical ingredients (APIs).
• Impurity Profiling: Used as a specified impurity marker in the development and validation of stability-indicating analytical methods, such as HPLC and UPLC, to ensure drug purity and safety.
• Metabolite Research: Critical for in-vitro and in-vivo metabolic studies to understand the biotransformation pathways and pharmacokinetics of nizatidine.
• Method Development & Validation: Employed as a critical analyte in establishing analytical procedures for regulatory submissions (e.g., ICH guidelines Q2(R1), Q3B(R2)).
• Quality Control Laboratories: Essential for routine batch testing in QC labs to monitor impurity levels and comply with pharmacopoeial standards (USP, EP).
• Academic & Clinical Research: Supports fundamental research on gastric acid secretion, receptor binding studies, and the pharmacological effects of H₂-antagonists.

Basic Information

Item	Details
Product Name	Nizatidine Sulfoxide
CAS No.	129927-19-1
Molecular Formula	C12H21N5O3S2
Molecular Weight	347.46 g/mol
Synonyms	Nizatidine S-Oxide; Nizatidine Sulfoxide Impurity; N-[2-[[[2-[(Dimethylamino)methyl]-4-thiazolyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine S-Oxide; Axid Sulfoxide; LY139037 Sulfoxide; 1,1-Ethenediamine, N-[2-[[[2-[(dimethylamino)methyl]-4-thiazolyl]methyl]sulfinyl]ethyl]-N'-methyl-2-nitro-; Nizatidine Related Compound C (USP)
EINECS	Contact for details

Quality Control

Our Nizatidine Sulfoxide is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, related substance analysis, and identity confirmation (IR, NMR) to ensure it meets high-purity standards suitable for use as a reference material. A comprehensive Certificate of Analysis (COA) detailing all test results is provided with every shipment. We support compliance with ICH guidelines and relevant pharmacopoeial requirements.

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 structure
Identification (HPLC)	Retention time matches reference
Assay (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.