Description

11-Desmethyl Rifaximin-D4 is a deuterium-labeled analog of a key rifaximin metabolite, serving as a critical internal standard for precise analytical quantification. This high-purity reference material is essential for ensuring accuracy and reliability in pharmacokinetic and metabolic studies. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities engaged in advanced bioanalytical method development and validation.

Application

• Internal Standard for LC-MS/MS Analysis: Used as a stable isotope-labeled internal standard for the accurate quantification of 11-desmethyl rifaximin and related compounds in complex biological matrices like plasma, serum, and urine.
• Drug Metabolism and Pharmacokinetics (DMPK) Studies: Facilitates precise tracking of drug metabolite formation, distribution, and elimination in preclinical and clinical research.
• Bioanalytical Method Development and Validation: Critical for developing robust, sensitive, and specific HPLC or UPLC methods coupled with mass spectrometry to meet regulatory guidelines (e.g., FDA, EMA).
• Pharmacological Research: Supports investigations into the metabolic pathways and bioavailability of rifaximin and its derivatives.
• Quality Control in Reference Material Production: Serves as a calibrant or system suitability standard in the quality control of non-labeled active pharmaceutical ingredients (APIs) and metabolites.

Basic Information

Product Name	11-Desmethyl Rifaximin-D4
CAS No.	1316302-12-1
Molecular Formula	C43H47D4N3O11
Molecular Weight	~ 793.91 g/mol
Synonyms	Rifaximin Impurity D4; 11-Desmethylrifaximin-D4; 11-Demethylrifaximin-d4; 2S,16Z,18E,20S,21S,22R,23R,24R,25S,26S,27S,28E)-5,6,21,23,25-Pentahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-2,7-(epoxypentadeca[1,11,13]trienimino)benzofuro[4,5-e]pyrido[1,2-a]benzimidazole-1,15(2H)-dione-25,27,28,29-d4; Deuterated 11-Desmethyl Rifaximin; Rifaximin metabolite D4 internal standard.
EINECS	Contact for details

Quality Control

Our 11-Desmethyl Rifaximin-D4 is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for sensitive analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing results for identity, purity (by HPLC), isotopic enrichment, and related substances. We adhere to relevant industry standards for reference materials to support your regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	Off-white to yellow powder
Identification (IR)	Conforms to structure
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Isotopic Purity (D-enrichment)	≥ 98.0 atom % D
Chemical Purity (by HPLC)	≥ 90.0%
Related Substances (HPLC)	Individual impurity ≤ 2.0%
Water Content (KF)	≤ 5.0%

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