Description

Tiamulin Impurity E (Tiamulone, 11-Oxo Tiamulin) is a high-purity chemical reference standard, specifically identified as a key impurity and degradation product of the pleuromutilin antibiotic Tiamulin. This compound is essential for pharmaceutical research and development, serving as a critical marker for ensuring the purity, safety, and efficacy of Tiamulin-based veterinary and pharmaceutical products. It is primarily utilized by analytical chemists, quality control laboratories, and regulatory affairs professionals in the pharmaceutical and animal health industries for method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Tiamulin Impurity E in active pharmaceutical ingredient (API) and finished product analysis.
• Method Development & Validation: Critical for developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS, to monitor impurities in Tiamulin.
• Quality Control & Assurance (QC/QA): Enables precise impurity profiling to ensure Tiamulin batches meet stringent pharmacopeial (e.g., USP, EP) and internal specification limits.
• Stability Studies: Employed in forced degradation and long-term stability studies to understand the degradation pathways of Tiamulin and establish appropriate shelf-life.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary data on impurity levels for drug master files (DMFs) and marketing authorization applications.
• Research on Degradation Chemistry: Serves as a tool in research to investigate the formation mechanisms and chemical behavior of Tiamulin under various conditions.

Basic Information

Product Name	Tiamulin Impurity E
CAS No.	113323-39-0
Molecular Formula	C28H47NO4S
Molecular Weight	493.75 g/mol
Synonyms	Tiamulone; 11-Oxo Tiamulin; 11-Oxotiamulin; (3aS,4R,5S,6S,8R,9R,9aR,10R)-6-Ethenyl-5-hydroxy-4,6,9,10-tetramethyl-1-oxo-5,6,8,9,9a,10-hexahydro-3aH-cyclopenta[b]naphtho[2,1-d]furan-8-yl 2-diethylaminoethylsulfanylacetate; Tiamulin Related Compound E; Tiamulin EP Impurity E; Tiamulin USP Impurity E
EINECS	Contact for details

Quality Control

Every batch of Tiamulin Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your regulatory and quality requirements.

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) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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