Description

Ranitidine Impurity C is a specified impurity and a critical reference standard used in the pharmaceutical quality control process. This compound is essential for ensuring the purity, safety, and efficacy of ranitidine hydrochloride, a widely used histamine H2-receptor antagonist. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch analysis.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in ranitidine hydrochloride active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and other chromatographic methods to establish specificity, linearity, and detection limits for impurity profiling.
• Quality Control & Batch Release Testing: Critical for compliance with pharmacopeial monographs (USP, EP, BP) which set strict limits for specified impurities in ranitidine.
• Stability Studies: Employed to monitor the formation of degradation products in ranitidine formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to demonstrate control over the manufacturing process.
• Research & Development: Used in studies to understand the degradation pathways and chemical behavior of ranitidine.

Basic Information

Product Name	Ranitidine Impurity C
CAS No.	73851-70-4
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; 1,1-Ethenediamine, N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-; Ranitidine Impurity C (EP); Ranitidine Related Compound C (USP); Nitroethenediamine impurity of Ranitidine; Ranitidine Nitroso Impurity Precursor
EINECS	Contact for details

Quality Control

Our Ranitidine Impurity C is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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