Description

Roxatidine Acetate CAS NO 78628-28-1 is a high-purity pharmaceutical intermediate and active pharmaceutical ingredient (API) of significant commercial importance. It serves as the key precursor for the synthesis of Roxatidine, a potent and selective histamine H₂-receptor antagonist used to inhibit gastric acid secretion. This compound is essential for manufacturers in the pharmaceutical industry engaged in the production of anti-ulcer and gastroprotective medications, requiring reliable supply of materials that meet stringent pharmacopeial standards for purity and consistency.

Application

• Pharmaceutical API Synthesis: Primary use as the direct precursor in the commercial manufacturing of Roxatidine acetate hydrochloride, the active drug substance.
• Anti-Ulcer Medication Production: Critical intermediate for formulating finished dosage forms (e.g., tablets, capsules) used in the treatment of gastric ulcers, duodenal ulcers, and gastroesophageal reflux disease (GERD).
• Research & Development: Serves as a reference standard and building block in medicinal chemistry research for developing new H₂-receptor antagonists or related therapeutic agents.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for cGMP production of generic and proprietary pharmaceutical products.
• Regulatory Submissions: Used to generate batches for stability studies, bioequivalence testing, and documentation required for ANDA (Abbreviated New Drug Application) and other global regulatory filings.

Basic Information

Product Name	Roxatidine Acetate
CAS No.	78628-28-1
Molecular Formula	C19H28N2O4
Molecular Weight	348.44 g/mol
Synonyms	2-Acetoxy-N-[3-[3-(1-piperidinylmethyl)phenoxy]propyl]acetamide; Roxatidine Acetate Ester; (RS)-2-(Acetyloxy)-N-[3-[3-(piperidin-1-ylmethyl)phenoxy]propyl]acetamide; TZU-0460 Acetate; Roxatidine precursor; Roxatidine base acetate
EINECS	Contact for details

Quality Control

Our Roxatidine Acetate is manufactured under strict quality management systems, targeting specifications suitable for pharmaceutical use. Each batch is subjected to comprehensive analytical testing, including identification, assay, and impurity profiling via HPLC, to ensure compliance with in-house standards aligned with ICH guidelines. A Certificate of Analysis (COA) documenting purity, related substances, residual solvents, and other critical parameters is provided with every shipment to guarantee traceability and consistency for our global B2B clients.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed after opening to prevent degradation from atmospheric moisture. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥98.5%
Related Substances (HPLC)	Total impurities ≤1.5% Any single unknown impurity ≤0.5%
Loss on Drying	≤1.0%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm

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