Description

Roxatidine Acetate Hydrochloride is a high-purity pharmaceutical intermediate and active pharmaceutical ingredient (API). This compound is a histamine H₂-receptor antagonist, primarily valued for its role in the synthesis of advanced therapeutic agents targeting gastric acid secretion. It is essential for pharmaceutical manufacturers and research institutions engaged in developing and producing treatments for peptic ulcers and gastroesophageal reflux disease (GERD). Consistent quality and reliable supply are critical for ensuring the integrity of downstream pharmaceutical formulations.

Application

• Pharmaceutical API Synthesis: Primary use as an active ingredient in the manufacture of anti-ulcer medications.
• Research & Development: Serves as a key reference standard and building block in pharmacological and clinical research for gastrointestinal disorders.
• Formulation Development: Used in the development of various dosage forms, including tablets and capsules.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for the production of finished drug products.
• Analytical Testing: Employed as a high-purity standard in quality control laboratories for HPLC and spectroscopic assays.

Basic Information

Product Name	Roxatidine Acetate Hydrochloride
CAS No.	93793-83-0
Molecular Formula	C19H28N2O4•HCl
Molecular Weight	384.90 g/mol
Synonyms	Roxatidine Acetate HCl; Roxatidine Acetate Hydrochloride Salt; 2-Acetoxy-N-[3-[3-(1-piperidinylmethyl)phenoxy]propyl]acetamide Hydrochloride; TZU-0460; Altat; Roxatidine Acetate Monohydrochloride; Roxatidine Acetate Hydrochloride (JP17); Roxatidine Acetate Hydrochloride (USP)
EINECS	Contact for details

Quality Control

Our Roxatidine Acetate Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. We provide Certificates of Analysis (COA) with detailed results for parameters including assay, related substances, and residual solvents. Our quality commitment aligns with ICH guidelines and relevant pharmacopeial standards (e.g., USP, JP).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed to minimize exposure to atmospheric moisture. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Sulfated Ash	≤ 0.1%

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