Description

Tiamulin Related Compound A is a high-purity chemical reference standard essential for analytical and quality control processes. This compound is critical for ensuring the purity, safety, and efficacy of the veterinary antibiotic Tiamulin, which is widely used in animal health. It serves as a vital tool for researchers, analytical laboratories, and pharmaceutical manufacturers involved in method development, validation, and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Tiamulin and its related substances in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: A critical component in developing and validating High-Performance Liquid Chromatography (HPLC), LC-MS, and other chromatographic methods for purity analysis.
• Quality Control & Assurance (QC/QA): Used in routine batch testing within pharmaceutical manufacturing to monitor impurities and ensure product specifications are met according to pharmacopeial standards (e.g., USP, EP).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of analytical method specificity and impurity profiling.
• Research & Development (R&D): Employed in stability studies, degradation pathway elucidation, and metabolic research related to Tiamulin.
• Contract Research Organizations (CROs): Essential for laboratories providing outsourced analytical testing services to the animal health industry.

Basic Information

Product Name	Tiamulin Related Compound A
CAS No.	31716-01-5
Molecular Formula	C28H47NO4S
Molecular Weight	493.75 g/mol
Synonyms	14-Deoxy-14-[(2-diethylaminoethyl)mercaptoacetoxy]mutilin; Tiamulin Impurity A; Tiamulin EP Impurity A; Tiamulin Related Substance A; (3aS,4R,5S,6S,8R,9R,9aR,10R)-6-Ethenyl-5-hydroxy-4,6,9,10-tetramethyl-1-oxodecahydro-3a,9-propano-3aH-cyclopentacycloocten-8-yl 2-[(2-diethylaminoethyl)sulfanyl]acetate
EINECS	Contact for details

Quality Control

Our Tiamulin Related Compound A is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity assay by HPLC, and control of specific impurities. We provide full traceability and Certificates of Analysis (COA) that detail all test results against stringent in-house specifications, supporting compliance with pharmacopeial guidelines for reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to maintain stability and purity. Handle with appropriate laboratory safety procedures.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.