Description

Demethylamino Ranitidine-D6 Acetamide Sodium is a high-purity, stable isotope-labeled internal standard critical for advanced analytical chemistry. This compound is essential for ensuring the accuracy and reliability of quantitative mass spectrometry analyses, particularly in regulated environments. It is primarily used by pharmaceutical research and development laboratories, contract research organizations (CROs), and quality control departments for method development, validation, and bioanalytical studies of ranitidine and related compounds.

Application

• Internal Standard for LC-MS/MS: Primary application as a deuterated internal standard for the precise quantification of ranitidine and its metabolites in complex biological matrices like plasma, serum, and urine.
• Pharmaceutical R&D: Used in pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) studies during drug development to ensure data integrity.
• Bioanalytical Method Development: Critical for developing and validating robust, sensitive, and specific analytical methods compliant with FDA, EMA, and ICH guidelines.
• Metabolite Identification & Profiling: Aids in the identification and structural elucidation of drug metabolites using high-resolution mass spectrometry.
• Clinical Research: Supports clinical trial sample analysis for therapeutic drug monitoring and compliance studies.
• Forensic & Doping Control Analysis: Employed in specialized laboratories for the accurate detection and quantification of pharmaceutical substances.
• Quality Control & Stability Testing: Used in pharmaceutical manufacturing QC to monitor drug substance and product stability and impurity profiles.

Basic Information

Product Name	Demethylamino Ranitidine-D6 Acetamide Sodium
CAS No.	1346606-56-1
Molecular Formula	C13H17D6N4O3S • Na
Molecular Weight	Contact for details
Synonyms	Ranitidine-d6 (N-Desmethyl) Acetamide Sodium Salt; N-Desmethyl Ranitidine-d6 Acetamide Sodium; [2-[[[5-[(Dimethylamino-d6)methyl]-2-furanyl]methyl]thio]ethyl]-N-methyl-2-nitro-1,1-ethenediamine Acetamide Sodium Salt; Deuterated Ranitidine N-Desmethyl Metabolite Standard; Ranitidine D6 Internal Standard (N-Desmethyl); Sodium;2-[2-[[[5-[(dimethylamino-d6)methyl]furan-2-yl]methyl]sulfanyl]ethyl-(methyl)amino]-N-(2-nitroethenylidene)acetamide
EINECS	Contact for details

Quality Control

Every batch of Demethylamino Ranitidine-D6 Acetamide Sodium is manufactured and analyzed under strict quality systems. We guarantee high chemical and isotopic purity to meet the exacting demands of quantitative mass spectrometry. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request, providing detailed analytical data including HPLC purity, NMR confirmation, and isotopic enrichment.

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 material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing desiccated at -20°C.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 98.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
Chemical Purity (by NMR)	Conforms
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH limits

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