Amikacin Sulfate (CAS No.: 39831-55-5) - Aminoglycoside Antibacterial for Severe Gram-Negative Infections
As a professional supplier of pharmaceutical-grade antibacterial active ingredients, we provide high-purity Amikacin Sulfate that strictly complies with global pharmacopoeia standards (USP, EP, BP, CP). A semi-synthetic aminoglycoside antibiotic derived from kanamycin A, it exhibits potent bactericidal activity against multidrug-resistant Gram-negative bacteria-including strains resistant to other aminoglycosides (e.g., gentamicin, tobramycin). It is primarily used in human medicine for treating life-threatening infections and in select veterinary practice for livestock and companion animals, serving as a critical "last-line" agent against drug-resistant pathogens.
Product Basic Information
| Item | Details |
|---|---|
| Product Name | Amikacin Sulfate |
| CAS No. | 39831-55-5 |
| Synonyms | O-3-Amino-3-deoxy-α-D-glucopyranosyl-(1→6)-O-[6-amino-6-deoxy-α-D-glucopyranosyl-(1→4)]-N¹-(4-amino-2-hydroxybutanoyl)-2-deoxy-D-streptamine sulfate; Amikin® (brand name for human formulations) |
| Molecular Formula | C₂₂H₄₃N₅O₁₃·nH₂SO₄ (typically 2:1 sulfate salt, molecular weight ~781.7) |
| Molecular Weight | ~781.7 (for 2:1 sulfate salt) |
| Appearance | White to off-white crystalline powder or hygroscopic granules; Odorless |
| Specification | - Pharmaceutical Grade: Purity ≥95.0% (HPLC); Assay (as amikacin) 690–770 μg/mg (based on anhydrous, sulfate-free basis); Loss on drying ≤7.0%; Residue on ignition 19.0%–23.0% (sulfate content); Heavy metals (Pb≤10ppm, Hg≤1ppm, Cd≤1ppm); Endotoxin ≤0.3 EU/mg (for injectable use) |
| Melting Point | >250°C (with decomposition) |
| Solubility | Freely soluble in water (≥500 g/L at 25°C); Slightly soluble in methanol; Practically insoluble in ethanol, acetone, chloroform |
| Storage Conditions | Store in a cool (15–25°C), dry, light-protected container; Sealed to prevent moisture absorption (hygroscopic) and degradation; Avoid contact with strong acids/bases; Shelf life: 36 months for pharmaceutical grade, 24 months for veterinary grade |
Core Functions & Mechanism of Action
CAS #39831-55-5 exerts a bactericidal effect by targeting the bacterial ribosome-interfering with protein synthesis, which is essential for bacterial growth and survival:
Ribosome Binding: Amikacin binds irreversibly to the 30S subunit of the bacterial ribosome, specifically targeting the 16S rRNA.
Protein Synthesis Disruption: This binding blocks two critical steps:
Initiation of protein synthesis (prevents formation of the ribosome-mRNA-tRNA complex).
Proofreading of newly synthesized proteins (leads to production of non-functional, toxic proteins).
Bacterial Death: Accumulation of non-functional proteins and disruption of membrane integrity cause bacterial cell lysis.
Key advantages of amikacin over other aminoglycosides:
Resistance Evasion: Modifications to its chemical structure (addition of a 4-amino-2-hydroxybutanoyl side chain) make it resistant to most aminoglycoside-modifying enzymes (AMEs)-the primary mechanism of aminoglycoside resistance in Gram-negative bacteria.
Broad Gram-Negative Spectrum: Active against Pseudomonas aeruginosa, Acinetobacter baumannii, Klebsiella pneumoniae, Escherichia coli, and Enterobacter spp.-including carbapenem-resistant (CRE) and extended-spectrum β-lactamase (ESBL)-producing strains.
Core Applications
Amikacin Sulfate CAS #39831-55-5 is reserved for severe, life-threatening bacterial infections (often in hospitalized patients) where other antibiotics are ineffective or contraindicated. It is administered parenterally (IV or IM) due to poor oral absorption.
1. Human Pharmaceutical Field
1.1 Severe Gram-Negative Infections
Hospital-Acquired Pneumonia (HAP) & Ventilator-Associated Pneumonia (VAP): Treats infections caused by multidrug-resistant Pseudomonas aeruginosa or Acinetobacter baumannii. IV dose: 15–20 mg/kg/day (single daily dose or divided into 2 doses) for 7–14 days, adjusted for renal function.
Septicemia & Bacteremia: For bloodstream infections caused by CRE or ESBL-producing Klebsiella pneumoniae / E. coli. IV dose: 15–20 mg/kg/day for 10–14 days, often combined with a β-lactam antibiotic (synergistic effect).
Complicated Urinary Tract Infections (cUTIs): Treats cUTIs resistant to other antibiotics (e.g., fluoroquinolones). IV/IM dose: 15 mg/kg/day for 7–10 days.
1.2 Other Infections
Skin & Soft Tissue Infections (SSTIs): For severe SSTIs (e.g., necrotizing fasciitis) caused by multidrug-resistant Gram-negative bacteria. IV dose: 15–20 mg/kg/day for 10–14 days, paired with surgical debridement.
Bone & Joint Infections: Treats osteomyelitis or septic arthritis caused by Pseudomonas aeruginosa. IV dose: 15–20 mg/kg/day for 4–6 weeks.
2. Veterinary Field (Livestock & Companion Animals)
Amikacin Sulfate CAS #39831-55-5 is used in cattle, pigs, dogs, and cats for treating severe Gram-negative infections, often when other antibiotics fail:
Bovine Respiratory Disease (BRD): Caused by multidrug-resistant Mannheimia haemolytica or Pasteurella multocida. IM dose: 7.5–10 mg/kg body weight once daily for 3–5 days.
Porcine Septicemia: For E. coli or Salmonella-induced septicemia in piglets. IM dose: 10–15 mg/kg once daily for 3–5 days.
Canine/Feline Urinary Tract & Skin Infections: For resistant E. coli (UTIs) or Pseudomonas aeruginosa (skin infections). IM dose: 5–10 mg/kg twice daily for 7–14 days.
Contraindications: Avoid use in neonates (nephrotoxicity risk) or animals with pre-existing renal impairment; not approved for poultry or dairy cattle (residue and toxicity risks).
Quality & Safety Assurance
As a critical "last-line" antibiotic, CAS #39831-55-5 requires strict quality control to ensure potency, purity, and safety-especially given its narrow therapeutic index (risk of nephrotoxicity and ototoxicity):
1. Manufacturing & Purity Control
Synthesis: Produced via semi-synthetic modification of kanamycin A (acylation with 4-amino-2-hydroxybutyric acid), followed by sulfation and purification via ion-exchange chromatography. The process ensures:
Minimal impurities (e.g., kanamycin A, degradation products) ≤2.0%;
Consistent sulfate content (19.0%–23.0%), critical for uniform potency.
GMP Compliance: Manufactured in Grade C/D cleanrooms (per ICH Q7 guidelines) for injectable-grade products, with strict control over endotoxin levels (≤0.3 EU/mg) to avoid sepsis.
2. Comprehensive Testing Protocol
| Test Item | Method | Acceptance Criterion |
|---|---|---|
| Purity & Assay | HPLC (C18 column, 205 nm detection) | Purity ≥95.0%; Assay 690–770 μg/mg (anhydrous, sulfate-free) |
| Related Substances | HPLC (gradient elution) | Kanamycin A ≤1.0%; Total impurities ≤2.0% |
| Endotoxin (Injectable Grade) | LAL (Limulus Amebocyte Lysate) Test | ≤0.3 EU/mg |
| Heavy Metals | ICP-MS (Inductively Coupled Plasma-Mass Spectrometry) | Pb≤10ppm, Hg≤1ppm, Cd≤1ppm |
| Solubility & Clarity | Gravimetric method (water, 25°C) | ≥500 g/L solubility; Clear solution (no turbidity) |
| Loss on Drying | Gravimetric method (105°C for 3 hours) | ≤7.0% |
3. Safety Reminders
Human Use:
Contraindications: Hypersensitivity to aminoglycosides; severe renal impairment (CrCl <30 mL/min); pre-existing hearing loss or tinnitus (ototoxicity risk).
Adverse Effects: Dose-dependent nephrotoxicity (monitor serum creatinine, BUN) and ototoxicity (monitor hearing/vestibular function); rare but serious: neuromuscular blockade (risk of respiratory depression in patients with myasthenia gravis).
Therapeutic Drug Monitoring (TDM): Required for patients with renal impairment, prolonged therapy (>7 days), or high doses-target peak concentration 20–30 μg/mL, trough concentration <10 μg/mL.
Veterinary Use:
Withdrawal Periods: Cattle: 28 days (meat); Pigs: 21 days (meat); Dogs/Cats: No withdrawal period (non-food animals).
Residue Warning: Prohibited in dairy cattle and laying hens-residues in milk/eggs pose human health risks.
Cooperation & Contact
We supply Amikacin Sulfate in grades tailored to injectable use for humans and animals:
Pharmaceutical Grade: Fine powder for IV/IM formulations (1kg–100kg per order, sealed aluminum foil bags with desiccants).
Veterinary Grade: Powder for livestock/companion animal injectables (10kg–500kg per order; monthly production capacity of 1500kg).
Value-added services include:
Providing DMF (Drug Master File) and CEP (Certificate of Suitability) for pharmaceutical-grade products to support EU/US/Asia registration.
Technical support for TDM protocols (human use) and veterinary formulation stability testing.
Batch-specific COA with endotoxin, purity, and assay results to ensure compliance.
If you are a pharmaceutical manufacturer, hospital supplier, or veterinary drug enterprise, please contact us for detailed cooperation:
Contact Information:
Email: sales@huarongpharma.com
Phone/WhatsApp: +86 13751168070
We adhere to the principles of "last-line quality, resistance management, and patient/animal safety" and look forward to partnering with global healthcare and animal health industries!
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