Description

Rifaximin Impurity 2 CAS NO 1351775-03-5 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the antibiotic Rifaximin by serving as a benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical quality control laboratories, research institutions, and manufacturers engaged in the development and production of Rifaximin-based medications.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Rifaximin active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical component in developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, for quality control testing.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity standards necessary for establishing specification limits and stability studies.
• Research & Development: Utilized in metabolic studies, degradation pathway analysis, and forced degradation studies to understand the stability profile of Rifaximin.
• Quality Assurance/Quality Control (QA/QC): Employed in routine batch release testing and stability monitoring to ensure product consistency and compliance with pharmacopeial standards (USP, EP).
• Calibration Standard: Acts as a precise calibration standard for analytical instrumentation to ensure accurate and reproducible analytical results.

Basic Information

Item	Details
Product Name	Rifaximin Impurity 2
CAS No.	1351775-03-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rifaximin Related Compound 2; Rifaximin Impurity B; Rifaximin EP Impurity B; Rifaximin USP Impurity; (11S,12R,13S,14R,15S,16R,17S,18R,19S,20R,21S,22R)-2,16-Diacetyl-8-ethoxy-1,6,10,15,19-pentahydroxy-5,11,13,17,21-pentamethyl-9-oxo-3,7,18,22-tetraoxatetracyclo[17.3.1.14,8.112,16]tetracosa-4,23-diene-14-carboxylic acid (IUPAC-based); Rifamycin SV Impurity related to Rifaximin; Antibiotic XF-73 Impurity
EINECS	Contact for details

Quality Control

Our Rifaximin Impurity 2 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity analysis, identity confirmation by spectroscopic methods, and stringent control of residual solvents and moisture content. We provide comprehensive Certificates of Analysis (COA) with batch-specific data, ensuring traceability and compliance with current industry and regulatory expectations for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	Off-white to light yellow powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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