Description

Ranitidine-D6 Impurity B is a stable isotope-labeled deuterated compound, specifically designed as a certified reference material (CRM) for analytical applications. This high-purity impurity standard is critical for ensuring the accuracy and reliability of mass spectrometry and chromatography methods in pharmaceutical development and quality control. It is an essential tool for researchers and quality assurance professionals in the pharmaceutical industry who require precise quantification of impurities and metabolites during method validation and stability studies.

Application

• Primary use as a certified reference standard for the quantification of Ranitidine-related impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Critical component in analytical method development and validation for HPLC, UPLC, and LC-MS/MS systems to ensure regulatory compliance.
• Used in pharmacokinetic and metabolic studies as an internal standard for the accurate tracing and analysis of Ranitidine and its metabolites.
• Essential for stability-indicating assays to monitor impurity profiles and degradation pathways in drug substance and product stability programs.
• Supports quality control (QC) laboratories in pharmaceutical manufacturing for batch release testing and impurity specification compliance.
• Valuable for regulatory submissions (e.g., to FDA, EMA) to demonstrate robust analytical control strategies for drug substances.

Basic Information

Product Name	Ranitidine-D6 Impurity B
CAS No.	1189903-94-3
Molecular Formula	C13H16D6N4O3S
Molecular Weight	314.42 g/mol
Synonyms	Ranitidine-d6 Impurity B; N-[2-[[[5-[(Dimethylamino-d6)methyl]-2-furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine; Deuterated Ranitidine Impurity B; Ranitidine EP Impurity B-d6; Ranitidine Related Compound B-d6; 1,1-Ethenediamine, N-[2-[[[5-[(dimethyl-d6-amino)methyl]-2-furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-; Ranitidine-d6 (Impurity B)
EINECS	Contact for details

Quality Control

Every batch of Ranitidine-D6 Impurity B is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and isotopic enrichment meet the highest standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity (by HPLC), isotopic purity (by MS), and other critical parameters. Our quality commitment aligns with the needs of cGMP/GLP-compliant laboratories.

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. This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Isotopic Purity (MS)	≥ 98.0 atom % D
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.