Tiamulin Fumarate

Tiamulin Fumarate (CAS 55297-95-5) is a high-purity, semi-synthetic pleuromutilin antibiotic raw material produced through controlled fermentation and chemical purification processes. It is designed for commercial veterinary pharmaceutical manufacturing and provides consistent physicochemical properties, controlled impurity profiles, and reliable batch-to-batch quality for downstream formulation and quality evaluation.

Molecular Identity: Molecular formula: C28H47NO4 · C4H4O4; molecular weight: 609.78. The molecule contains a pleuromutilin diterpenoid core and an active side chain.

Mechanism of Action: Tiamulin acts primarily by binding to the bacterial 50S ribosomal subunit and interfering with bacterial protein synthesis.

Antimicrobial Spectrum: It demonstrates activity against Mycoplasma species, Brachyspira hyodysenteriae, and selected Gram-positive bacterial pathogens relevant to veterinary applications.

Pharmacokinetics: Tiamulin is absorbed following oral administration and undergoes systemic distribution, with pharmacokinetic characteristics that support its use in veterinary pharmaceutical formulations.

Stereochemical Purity: Controlled manufacturing processes are used to maintain the required stereochemical profile and minimize unwanted optical isomers.

Thermal Profile: Thermal analysis can be used to evaluate the material's stability and behavior during pharmaceutical processing.

Powder Flowability: Bulk density may range from approximately 0.45 to 0.60 g/cm³, depending on particle size and processing conditions.

Hygroscopic Behavior: Moisture uptake is monitored during quality evaluation to support appropriate packaging, handling, and storage conditions.

Swine Feed Premixes: Used as an active ingredient in veterinary feed formulations for applications involving susceptible bacterial pathogens in swine.

Soluble Granule Systems: Suitable for development of water-soluble veterinary formulations intended for controlled administration through drinking-water systems.

Combination Formulations: Can be evaluated for compatibility with other veterinary pharmaceutical ingredients according to specific formulation requirements.

Batch Uniformity: Controlled particle size and powder characteristics support consistent blending and distribution during commercial premix manufacturing.
 

Process-Related Impurities: Multi-stage purification and crystallization processes are used to control process-related impurities and maintain consistent product quality.

Residual Solvents: Residual solvents are monitored using gas chromatography to ensure compliance with applicable pharmaceutical quality requirements.

Elemental Impurities: Elemental impurities are evaluated using appropriate analytical techniques such as inductively coupled plasma mass spectrometry.

Degradation Monitoring: Stability and forced-degradation studies can be used to identify and monitor potential degradation products under relevant stress conditions.

Chromatographic Purity: Each production lot is tested using validated HPLC methods to determine assay and chromatographic purity.

Microbial Limits: Microbiological quality is controlled according to applicable veterinary pharmaceutical and raw-material specifications.

Lot Traceability: Production and packaging records provide traceability from raw materials and processing stages through to the finished commercial batch.

Analytical Validation: Quality-control methods are evaluated for parameters such as specificity, linearity, accuracy, precision, and robustness where applicable.

Certificate of Analysis: Each commercial shipment can be supplied with a lot-specific Certificate of Analysis containing assay, impurity, physical, and other applicable quality results.

Technical Documentation: Product documentation can be provided to support customer qualification, formulation development, quality assessment, and regulatory review.

Safety Data Sheet: A current Safety Data Sheet can be supplied with information covering product identification, handling, storage, hazards, and emergency measures.

Quality Documentation: Relevant manufacturing and quality-control documentation can be provided according to customer qualification and regulatory requirements.

Temperature Control: Store in tightly closed containers under the storage conditions specified in the product documentation, typically in a cool and dry environment.

Light Protection: Protect the material from direct sunlight and excessive light exposure.

Humidity Management: Keep containers properly sealed and protect the product from excessive moisture to minimize caking and changes in physical properties.

Shelf Life: Shelf life is determined according to stability data and the manufacturer's validated storage conditions. Refer to the product label or Certificate of Analysis for the applicable shelf-life period.

Primary Container: Double-layer polyethylene bags or other suitable pharmaceutical-grade inner packaging can be used to protect the material from moisture and contamination.

Secondary Protection: Fiber drums or suitable rigid containers provide additional protection during storage and international transportation.

Standard Unit Size: Commercial packaging is commonly available in 25 kg net units, subject to customer requirements and order specifications.

Transport Conditions: Transportation requirements are determined according to product stability, destination regulations, packaging specifications, and customer requirements.

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