Description

Ranitidine Impurity B (Pheur) is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of ranitidine hydrochloride, a widely used pharmaceutical substance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The product is supplied with comprehensive analytical data to support stringent quality control protocols.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in ranitidine hydrochloride active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Essential for developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in ranitidine formulations under various stress conditions, supporting shelf-life determination.
• Regulatory Compliance & Documentation: Provides necessary data for regulatory filings (e.g., ANDA, NDA) with agencies like the US FDA and EMA, fulfilling ICH Q3A(R2) and Q3B(R2) guidelines on impurities.
• Pharmacopoeial Testing: Used in testing to meet the specifications outlined in pharmacopoeias such as USP (United States Pharmacopeia), EP (European Pharmacopoeia), and BP (British Pharmacopoeia).
• Research & Development: Serves as a key reagent in pharmaceutical R&D for studying the degradation pathways and chemical behavior of ranitidine.

Basic Information

Product Name	Ranitidine Impurity B (Pheur)
CAS No.	256948-32-0
Molecular Formula	C13H22N4O3S
Molecular Weight	314.41 g/mol
Synonyms	N-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine; Ranitidine Impurity B; Ranitidine Related Compound B; 1,1-Ethenediamine, N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-; PHEUR impurity B of ranitidine; EP Impurity B of Ranitidine; USP Ranitidine Related Compound B
EINECS	Contact for details

Quality Control

Every batch of Ranitidine Impurity B (Pheur) is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and Mass Spectrometry to ensure compliance with pharmacopoeial standards (USP/EP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to guarantee traceability and reliability for your critical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F), in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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