Description

25-Desacetyl Rifapentine is a key pharmaceutical intermediate and metabolite of the antibiotic rifapentine, playing a critical role in the development and quality control of anti-tuberculosis medications. Its primary value lies in its use as a reference standard for analytical testing, ensuring the purity, potency, and safety of the parent drug substance. This high-purity compound is essential for research institutions, pharmaceutical manufacturers, and analytical laboratories focused on infectious disease treatment and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of rifapentine and its related substances in drug products and active pharmaceutical ingredients (APIs).
• Metabolite Studies: Critical for pharmacokinetic and pharmacodynamic research to understand the metabolism, distribution, and efficacy of rifapentine.
• Impurity Profiling: Serves as a specified impurity standard in the development and validation of analytical methods (e.g., HPLC, LC-MS) to monitor drug purity.
• Process Development & Validation: Employed in the optimization and quality assurance of rifapentine synthesis and manufacturing processes.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing essential data for drug master files (DMFs) and new drug applications (NDAs).
• Academic & Clinical Research: Facilitates studies on tuberculosis treatment mechanisms, drug resistance, and the development of novel therapeutic regimens.

Basic Information

Item	Details
Product Name	25-Desacetyl Rifapentine
CAS No.	79039-56-8
Molecular Formula	C45H58N4O11
Molecular Weight	830.97 g/mol
Synonyms	25-Desacetylrifapentine; 3-[[(4-Cyclopentyl-1-piperazinyl)imino]methyl]rifamycin SV; Rifapentine Impurity C; Rifapentine Metabolite; 25-O-Desacetyl Rifapentine; 25-Deacetyl Rifapentine; Rifapentine Related Compound C
EINECS	Contact for details

Quality Control

Our 25-Desacetyl Rifapentine is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and MS, and residual solvent analysis to ensure it meets stringent standards for use as a reference material. Certificates of Analysis (COA) with detailed chromatographic data are provided to support your research and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	Reddish-brown powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
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.