Description

Ranitidine is a selective histamine H₂-receptor antagonist widely recognized for its therapeutic efficacy. This active pharmaceutical ingredient (API) is crucial for the formulation of medications that effectively manage and treat gastric acid-related disorders. It is essential for pharmaceutical manufacturers and research institutions engaged in developing treatments for ulcers, gastroesophageal reflux disease (GERD), and other hypersecretory conditions. Consistent quality and reliable supply are paramount for ensuring the safety and efficacy of the final drug product.

Application

• Pharmaceutical API: Primary use as the active ingredient in prescription and over-the-counter anti-ulcer and antacid medications.
• Tablet Formulation: Used in the production of solid oral dosage forms, including standard and effervescent tablets.
• Capsule Manufacturing: Incorporated into hard gelatin or vegetarian capsules for oral delivery.
• Syrup and Oral Solution Production: Utilized in the development of liquid formulations for pediatric or geriatric patients.
• Veterinary Pharmaceuticals: Applied in veterinary medicine for treating similar gastric conditions in animals.
• Reference Standard: Serves as a high-purity chemical standard for quality control and analytical testing in laboratories.
• Research and Development: Used in biochemical research to study H₂-receptor mechanisms and for the development of novel therapeutic agents.

Basic Information

Product Name	Ranitidine
CAS No.	117846-02-3
Molecular Formula	C₁₃H₂₂N₄O₃S
Molecular Weight	314.40 g/mol
Synonyms	Ranitidine Hydrochloride; Zantac; AH 19065; N-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine; 1,1-Ethenediamine, N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-; Ranitidin; Ranitidina; Ranitidinum
EINECS	Contact for details

Quality Control

Our Ranitidine is manufactured under strict quality management systems, targeting compliance with major pharmacopoeial standards such as USP, EP, and BP. Every batch undergoes a comprehensive suite of analytical tests including identification, assay, impurity profiling, and residual solvent analysis. A Certificate of Analysis (COA) documenting all test results is provided to ensure full traceability and compliance with your quality requirements.

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 protect contents from moisture. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on dried basis)
Loss on Drying	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Residual Solvents (GC)	Complies with ICH Q3C
Microbial Enumeration	Complies with EP/USP

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