Description

Ranitidine Impurity 21 is a high-purity chemical 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 studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of this specific impurity in ranitidine hydrochloride Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate sensitive analytical methods, primarily High-Performance Liquid Chromatography (HPLC) and LC-MS.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing in pharmaceutical manufacturing to monitor and control impurity levels against ICH guidelines.
• Regulatory Compliance & Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for impurity identification in drug dossiers.
• Stability Studies: Employed to track the formation and increase of this impurity over time under various stress conditions as part of drug stability testing programs.
• Research & Development (R&D): Used in synthetic chemistry and pharmaceutical R&D to study degradation pathways and the formation mechanisms of ranitidine-related impurities.

Basic Information

Product Name	Ranitidine Impurity 21
CAS No.	113224-25-2
Molecular Formula	C13H22N4O3S
Molecular Weight	314.40 g/mol
Synonyms	N-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine; Ranitidine Nitroso Impurity; Ranitidine Nitrosamine Impurity; Ranitidine Related Compound 21; NDMA Precursor Impurity; Nitrosodimethylamine (NDMA) Related Substance; 1,1-Ethenediamine, N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-
EINECS	Contact for details

Quality Control

Every batch of Ranitidine Impurity 21 is manufactured and analyzed under strict quality systems. The product undergoes rigorous identity confirmation, purity assessment, and impurity screening using advanced techniques like HPLC, LC-MS, and NMR to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

Item	Specification
Appearance	White to Off-white Solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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