Description

Tildipirosin is a semi-synthetic macrolide antibiotic belonging to the 16-membered ring subclass. This compound is valued for its potent and long-acting efficacy against key respiratory pathogens in veterinary medicine. It is primarily required by manufacturers in the animal health sector for the formulation of injectable solutions to treat bovine and swine respiratory diseases. The product is supplied as a high-purity active pharmaceutical ingredient (API) suitable for veterinary drug manufacturing.

Application

• Primary active ingredient in injectable veterinary formulations for the treatment of Bovine Respiratory Disease (BRD).
• Key component in medications targeting Swine Respiratory Disease (SRD).
• Used in the development of long-acting antibiotic preparations for livestock.
• Employed in veterinary pharmaceutical research and development for new antibiotic therapies.
• Potential use in aquaculture health management (subject to regional regulatory approvals).
• Reference standard for analytical and quality control laboratories.

Basic Information

Product Name	Tildipirosin
CAS No.	328898-40-4
Molecular Formula	C₄₁H₇₉N₅O₁₂
Molecular Weight	833.1 g/mol
Synonyms	4''-O-Acetyl-3,5-bis-O-demethyltylosin; Zuprevo (Veterinary Brand Name); Tildipirosinum; Tildipirosin (USAN); 20-Deoxy-20-{[(2R,3S,4R,5S)-5-(dimethylamino)-3,4-dihydroxytetrahydro-2-furanyl]methylamino}-4''-O-acetyl-5-O-demethyltylonolide; (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-11-{[(2S,3R,4S,6R)-4-(Dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy}-2-ethyl-3,4,10-trihydroxy-13-{[(2R,4R,5S,6S)-5-hydroxy-4-methoxy-4,6-dimethyloxan-2-yl]oxy}-3,5,8,10,12,14-hexamethyl-9-oxo-1-oxacyclotetradecane-4-carboxylic acid
EINECS	Contact for details

Quality Control

Our Tildipirosin is manufactured under a quality management system compliant with GMP principles for active pharmaceutical ingredients (APIs). Each batch undergoes rigorous analytical testing to meet stringent purity and identity specifications. A comprehensive Certificate of Analysis (COA) is provided with every shipment, detailing results for assay, related substances, residual solvents, and microbiological quality.

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 material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. Keep the container tightly sealed when not in use.

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% (on anhydrous basis)
Water Content (KF)	≤ 2.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Microbial Limits	Complies with Ph. Eur. 2.6.12/2.6.13

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