Description

Roxatidine is a selective histamine H2-receptor antagonist, a well-established active pharmaceutical ingredient (API) used to inhibit gastric acid secretion. This compound is valued for its therapeutic efficacy in treating and preventing gastrointestinal disorders associated with hyperacidity. It is primarily required by pharmaceutical manufacturers for the formulation of prescription medications targeting ulcers and gastroesophageal reflux disease (GERD).

Application

• Pharmaceutical API: Core active ingredient in prescription drugs for the treatment of gastric and duodenal ulcers.
• Acid Suppression Therapy: Used in medications for the management of gastroesophageal reflux disease (GERD) and Zollinger-Ellison syndrome.
• Preventative Formulations: Incorporated into prophylactic treatments to prevent stress-induced ulcers and NSAID-associated gastric damage.
• Clinical Research: Serves as a reference standard and key intermediate in pharmacological studies and new drug development.
• Generic Drug Manufacturing: Essential for producing cost-effective generic versions of established acid-reducing medications.

Basic Information

Product Name	Roxatidine
CAS No.	78273-80-0
Molecular Formula	C19H28N2O4
Molecular Weight	348.44 g/mol
Synonyms	Roxatidine Acetate Hydrochloride; TZU-0460; Altat; Roxatidine HCl; 2-Acetoxy-N-[3-[m-(1-piperidinylmethyl)phenoxy]propyl]acetamide Hydrochloride; 2-(Acetyloxy)-N-[3-[3-(1-piperidinylmethyl)phenoxy]propyl]acetamide Hydrochloride; Pifatidine
EINECS	Contact for details

Quality Control

Our Roxatidine is manufactured under strict quality management systems, ensuring it meets the rigorous standards required for pharmaceutical applications. Each batch is tested against comprehensive specifications, including identity, purity, and impurity profiles, typically referencing pharmacopeial guidelines. Certificates of Analysis (COA) documenting full compliance are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (typically 15-25°C). The product is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Heavy Metals	≤ 20 ppm

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