Description

Ranitidine Impurity 23 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of ranitidine-based drug products by enabling accurate identification and quantification of this specific impurity. It is essential for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in research, development, and compliance testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for calibrating analytical instruments and validating testing methods.
• Impurity Profiling and Identification: Used in HPLC, LC-MS, and GC-MS analyses to identify and quantify Ranitidine Impurity 23 in active pharmaceutical ingredients (APIs) and finished drug formulations.
• Method Development and Validation: Serves as a critical component in developing, optimizing, and validating chromatographic methods for impurity detection in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure drug substance and product specifications are met.
• Stability Studies: Used to track the formation of this impurity over time under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to demonstrate control of impurities.

Basic Information

Product Name	Ranitidine Impurity 23
CAS No.	82301-45-9
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; 1,1-Ethenediamine, N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-; Ranitidine Related Compound; Ranitidine EP Impurity C; Ranitidine USP Related Compound C; Nitroethenediamine derivative of Ranitidine
EINECS	Contact for details

Quality Control

Our Ranitidine Impurity 23 is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for a pharmaceutical reference standard. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary standards where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-30°C (59-86°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

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%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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