Quick Facts
| CAS Number | 1405-54-5 |
|---|---|
| Molecular Formula | C46H77NO17 |
| Molecular Weight | 916.112 |
| Pharmacopoeia | EP, CEP |
| Packaging | 25 KG/DRUM |
Product Story
Tylosin was discovered in the late 1950s by researchers at Eli Lilly and Company during a systematic soil-screening program. A soil sample collected in Thailand yielded a strain of Streptomyces fradiae (NRRL 2702) that produced a novel macrolide antibiotic with remarkable activity against Mycoplasma species — pathogens that were notoriously difficult to treat with existing antibiotics. Eli Lilly patented tylosin in 1960 (US Patent 2,965,547) and commercialized it under the brand name Tylan, which became one of the most important veterinary antibiotics of the 20th century. Tylosin is a 16-membered macrolide — structurally related to erythromycin (14-membered) but with a larger lactone ring that confers a distinct binding orientation at the 50S ribosomal subunit.
Tylosin's mechanism of action is bacteriostatic inhibition of bacterial protein synthesis. It binds to the 23S rRNA of the 50S ribosomal subunit, physically blocking the exit tunnel through which the growing polypeptide chain emerges, thereby arresting translation. Its spectrum covers the key respiratory and enteric pathogens in livestock: Mycoplasma gallisepticum and M. synoviae (chronic respiratory disease in poultry), Mycoplasma hyopneumoniae, Brachyspira hyodysenteriae (swine dysentery), Clostridium perfringens, and most Gram-positive bacteria. Notably, tylosin's coverage of spirochetes ( Brachyspira species) distinguishes it from most other macrolides and makes it one of the few effective treatments for swine dysentery.
The two commercial salt forms — tylosin tartrate and tylosin phosphate — serve entirely separate routes of administration. Tylosin tartrate is the water-soluble salt, providing high aqueous solubility (>500 mg/mL) that enables administration via drinking water to entire poultry flocks or swine herds. This is critical in acute disease outbreaks, where individual animal injection is impractical and in-feed medication takes days to ramp up. Tylosin phosphate, in contrast, is virtually water-insoluble and is formulated exclusively as a feed additive premix for growth promotion and sub-therapeutic disease prevention. The two salts are not interchangeable — a poultry producer facing a CRD outbreak requires tartrate salt for water medication; a feed mill formulating a growth-promotion premix uses phosphate salt. The tartrate salt typically commands a premium price reflecting both its higher value proposition in acute treatment scenarios and the additional manufacturing complexity of the tartrate salt conversion.
As of mid-2026, the global tylosin market is valued at approximately USD 1 billion, driven by expanding poultry and swine production in Asia, Latin America, and Africa. China dominates tylosin API manufacturing, with production concentrated in Shandong, Ningxia, and Inner Mongolia. Market trends include tightening regulatory restrictions on macrolide antibiotics as growth promoters (EU ban, WHO AGP reduction guidelines) and rising demand in emerging markets where livestock production is intensifying. CEP certification confirms full compliance with EP monograph and European veterinary GMP standards. KingWish supplies CEP-certified tylosin tartrate supporting veterinary pharmaceutical manufacturers in regulated and emerging markets.
Quality Specifications
| Potency (microbiological assay, dried basis) | ≥ 800 IU/mg, per EP monograph |
|---|---|
| Related Substances (HPLC) | Tylosin A ≥ 80%; tylosin B ≤ 10%; tylosin C ≤ 7%; tylosin D ≤ 6%; any individual unspecified ≤ 3% |
| pH (2.5% aqueous solution) | 5.0 - 7.4 |
| Water Content (Karl Fischer) | ≤ 4.5% |
| Residual Solvents | Compliant with ICH Q3C; methanol ≤ 3,000 ppm |
| Regulatory Filing | CEP (Certificate of Suitability, EDQM) — valid and active |
| GMP Status | Manufactured under ICH Q7 GMP conditions, CEP confirmed |
Veterinary Applications
Poultry — Drinking Water Medication
Chronic respiratory disease (CRD) from Mycoplasma gallisepticum/synoviae. Standard dosage: 0.5 g tylosin/L drinking water for 3-5 consecutive days. Also effective for necrotic enteritis (Clostridium perfringens). Mass medication advantage: entire flock treated simultaneously.
Swine — Swine Dysentery & Respiratory Disease
Swine dysentery (Brachyspira hyodysenteriae): 0.25 g/L drinking water for 3-10 days. Enzootic pneumonia (M. hyopneumoniae). Proliferative enteropathy (ileitis). Tylosin is one of few effective antibiotics against Brachyspira.
Additional Applications
- Soluble powder formulations: Tylosin tartrate is used as the active ingredient in veterinary soluble powder products, either as a mono-component (Tylosin 50%/100% WSP) or in combination with other compatible APIs.
- Injectable preparations: Tylosin base (from tartrate) reconstituted as tylosin 200 mg/mL injectable for cattle and swine. Intramuscular, 8-10 mg/kg body weight, 2-3 times daily.
- Feed additive via premix: While phosphate salt is preferred for feed, tartrate can be formulated into feed premixes for strategic medication programs in some jurisdictions.
Frequently Asked Questions
Sourcing Tylosin Tartrate: Key Checks
Documentation
Request CoA with microbiological potency (IU/mg, NOT just weight-based assay), HPLC chromatographic purity (tylosin A/B/C/D profile), pH of solution, water content (KF), residual solvents, and heavy metals. For EU/EEA, confirm active CEP status directly with the EDQM database. Verify the CEP covers the specific manufacturing site — site transfers without updated CEP are a compliance gap. Request batch-specific endotoxin data if the API is intended for injectable formulations.
Red Flags
Tylosin A below 80% with elevated B, C, or D components indicates fermentation process problems or product degradation. Potency reported only as "passes" without IU/mg value — especially suspicious for a fermentation product where batch-to-batch variability is inherent. CEP claims that cannot be verified on the EDQM database. Prices below the China FOB benchmark for CEP-certified material — tylosin tartrate commands a premium over phosphate, and non-CEP material should cost less.
Packaging & Logistics
Standard: 25 KG/DRUM with inner food-grade PE liner. Tylosin tartrate is hygroscopic — confirm air-tight seal and consider aluminium barrier bags for long-distance or tropical shipments. Store at controlled room temperature, protect from moisture. Standard lead time 4-8 weeks. Tylosin tartrate is relatively stable under proper storage (shelf life 3 years), but moisture ingress accelerates degradation and reduces potency.
Market Context
Global tylosin market valued at approximately USD 1 billion, growing modestly driven by poultry/swine production expansion in Asia and Africa. China accounts for dominant API production share. Key trend: EU ban on antibiotic growth promoters and WHO AGP reduction guidelines are shifting demand from phosphate (feed-grade) to tartrate (therapeutic-grade) as producers pivot from prevention to treatment. CEP certification is the key market-access differentiator. Market report