Description

Rifaximin Impurity B 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 the antibiotic Rifaximin during its development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) units, and regulatory affairs departments. The material serves as an essential tool for method validation, impurity profiling, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Rifaximin Impurity B in active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to monitor and control impurity levels.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure Rifaximin API and formulations meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Used to track the formation and growth of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf life.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research & Development: Supports synthetic chemistry research aimed at understanding impurity formation pathways and developing purification processes.

Basic Information

Product Name	Rifaximin Impurity B
CAS No.	1351775-04-6
Molecular Formula	C43H51N3O11
Molecular Weight	785.88 g/mol
Synonyms	(2S,16Z,18E,20S,21S,22R,23R,24R,25S,26R,27S,28E)-5,6,21,23,25-Pentahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-1,7-dioxo-1,2-dihydro-3H-2,6-epoxypyrido[2',1':11,12][1]oxazacyclotetracosine-3,13,19-trione; Rifaximin Related Compound B; Rifaximin EP Impurity B; Rifaximin USP Impurity B; (3R,4R,5S,6R,8R,9R,10R,11R,12S,13R,14S)-6-[[(2S,5R,6S)-5-(dimethylamino)-6-methyloxan-2-yl]oxy]-14-ethyl-12,13-dihydroxy-4-[(1E)-1-hydroxy-3-methylbut-1-en-2-yl]-7-methoxy-3,5,7,9,11,13-hexamethyl-1-oxacyclotetradecane-2,8,10-trione
EINECS	Contact for details

Quality Control

Our Rifaximin Impurity B is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identification by spectroscopic methods (IR, MS, NMR), and control of related substances, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and compliance.

Storage

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

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
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.