Quick Facts
| CAS Number | 1405-41-0 |
|---|---|
| Molecular Formula | C21H43N5O7 |
| Molecular Weight | ~575.67 (Mixture of C1, C1a, C2) |
| Pharmacopoeia | EP,BP,USP |
| Packaging | 25 KG/DRUM |
Product Overview
Gentamicin was discovered in 1963 by Dr. Marvin J. Weinstein and colleagues at Schering Corporation from the soil actinobacterium Micromonospora purpurea (later renamed M. echinospora). It was the first aminoglycoside discovered from a Micromonospora species rather than from Streptomyces — a breakthrough that opened an entirely new microbial genus for antibiotic discovery. Gentamicin entered human clinical use in 1969 and quickly became a workhorse injectable aminoglycoside for serious Gram-negative infections. Its veterinary adoption followed rapidly and it remains the most widely prescribed aminoglycoside antibiotic in veterinary medicine worldwide.
Unlike spectinomycin, which is a pure aminocyclitol compound, gentamicin is a complex mixture of structurally related components — primarily C1, C1a, and C2 — each contributing a slightly different antimicrobial profile. This complexity is both a strength and a quality-control challenge: the component ratio is the single most critical parameter when evaluating gentamicin API quality. Gentamicin binds irreversibly to the 30S ribosomal subunit, causing codon misreading and bactericidal protein synthesis inhibition. It exhibits concentration-dependent killing, meaning higher peak concentrations produce more rapid bacterial eradication — a principle that guides both dosing regimens and therapeutic drug monitoring in clinical practice.
Gentamicin's defining clinical advantage is its activity against Pseudomonas aeruginosa, a pathogen that few other veterinary antibiotics reliably cover. Combined with potent activity against Enterobacteriaceae (E. coli, Klebsiella, Proteus, Salmonella), this makes gentamicin the drug of choice for serious Gram-negative sepsis, complicated urinary tract infections, and hospital-acquired infections in veterinary patients. In food animals, it is formulated as oral solutions for enteric infections in piglets and calves, injectable solutions for systemic therapy, intramammary preparations for mastitis, and topical formulations for wound and ophthalmic infections.
As of mid-2026, the global gentamicin API market is valued in the hundreds of millions of USD, driven by both human and veterinary demand. China is the dominant producer, with fermentation facilities concentrated in Zhejiang, Fujian, and Shandong provinces. However, gentamicin fermentation is technically demanding — achieving the correct component ratio and potency requires strict process control — making reliable supply from GMP-certified facilities a genuine differentiator. KingWish supplies gentamicin sulphate meeting EP, BP, and USP monographs, with full component-ratio HPLC data on every CoA.
Quality Specifications
| Component Ratio (HPLC) | C1: 25-50%; C1a: 10-35%; C2+C2a: 25-55% per USP monograph |
|---|---|
| Potency (Microbiological Assay) | ≥ 590 IU/mg (dried basis), per USP/EP |
| Sulphate Content | 32.0-37.0% (USP specification) |
| Methanol (Residual Solvent) | ≤ 3,000 ppm, per ICH Q3C |
| Water Content (Karl Fischer) | ≤ 15.0% (USP) |
| Heavy Metals | ≤ 20 ppm |
| GMP Status | Manufactured under ICH Q7 GMP conditions |
Veterinary Applications
Oral Solution (Swine & Poultry)
Gentamicin 5-10% oral solution for E. coli and Salmonella enteritis in piglets and calves. Drinking water: 50-100 mg/L for 3-5 days in poultry. Negligible oral absorption confines action to the gut lumen.
Injectable (All Species)
4% or 10% injectable solution. IM/SC: 4-6 mg/kg once or twice daily for systemic Gram-negative infections. Requires therapeutic drug monitoring in at-risk patients due to nephrotoxicity potential.
Therapeutic Areas
- Swine: E. coli enteritis, Salmonella enteritis, Gram-negative septicemia in piglets
- Poultry: Colibacillosis, salmonellosis (drinking water medication, gut-localized)
- Dairy Cattle: Mastitis (intramammary), metritis (intrauterine), calf enteritis
- Companion Animals: Serious Gram-negative infections, UTI, wound infections, ophthalmic infections
Sourcing Gentamycin Sulphate: Key Checks
Documentation
The most critical document is the CoA with component-ratio HPLC data. Verify C1, C1a, and C2+C2a percentages fall within USP/EP limits. Also request microbiological potency assay (IU/mg), residual methanol analysis, and sulphate content.
Red Flags
Component ratios outside pharmacopoeia limits (e.g., C1 > 50% or C1a > 35%), potency below 590 IU/mg, methanol above 3,000 ppm, reluctance to share HPLC chromatogram, and prices significantly below market — gentamicin fermentation has a real cost floor.
Packaging & Logistics
Standard: 25 KG/DRUM. Custom packaging available. Gentamicin sulphate is hygroscopic — store in tightly sealed containers at controlled room temperature (15-30°C), protected from moisture. Standard lead time 4-8 weeks.
Market Context
Global gentamicin market is among the largest veterinary aminoglycoside segments, driven by dual human and veterinary demand. China dominates API fermentation. Capacity consolidation in Zhejiang province has tightened supply; working with an established supplier ensures batch-to-batch consistency. Market report