Sulbactam Sodium (CAS No.: 69388-84-7) - β-Lactamase Inhibitor for Enhancing Penicillin/ Cephalosporin Efficacy
As a professional supplier of pharmaceutical-grade antibacterial adjuvant active ingredients, we provide high-purity Sulbactam Sodium that strictly complies with global pharmacopoeia standards (USP, EP, BP, CP). A synthetic β-lactamase inhibitor, it has no meaningful intrinsic antibacterial activity but plays a critical role in restoring the efficacy of β-lactam antibiotics (e.g., ampicillin, cefoperazone) against drug-resistant bacteria. By irreversibly inhibiting bacterial β-lactamase enzymes (which break down β-lactam antibiotics), it expands the spectrum of these antibiotics to include β-lactam-resistant strains-making it a key component in combating multidrug-resistant bacterial infections in human medicine and select veterinary practice.
Product Basic Information
| Item | Details |
|---|---|
| Product Name | Sulbactam Sodium |
| CAS No. | 69388-84-7 |
| Synonyms | (2S,5R)-3,3-Dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid 4,4-dioxide sodium salt; β-Lactamase inhibitor adjuvant |
| Molecular Formula | C₈H₁₀NNaO₅S |
| Molecular Weight | 255.22 |
| Appearance | White to off-white crystalline powder; Odorless or with a slight characteristic odor |
| Specification | - Pharmaceutical Grade: Purity ≥98.0% (HPLC); Assay (as sulbactam) 97.0%–103.0%; Specific optical rotation [α]²⁰D +223° to +237° (in water, c=1); Loss on drying ≤1.0%; Residue on ignition 18.0%–20.0% (sodium content); Heavy metals (Pb≤10ppm, Hg≤1ppm, Cd≤1ppm); Residual solvents (ethanol ≤500ppm, acetone ≤500ppm) |
| Melting Point | 196–200°C (with decomposition) |
| Solubility | Freely soluble in water (≥200 g/L at 25°C); Soluble in methanol, ethanol; Slightly soluble in acetone; Insoluble in chloroform, ether |
| Storage Conditions | Store in a cool (15–25°C), dry, light-protected container; Sealed to prevent moisture absorption and hydrolysis (β-lactam ring is moisture-sensitive); Avoid contact with strong acids/bases; Shelf life: 36 months for pharmaceutical grade, 24 months for veterinary grade |
Core Functions & Mechanism of Action
Bacterial resistance to β-lactam antibiotics (e.g., penicillins, cephalosporins) primarily arises from the production of β-lactamase enzymes-these enzymes cleave the β-lactam ring of antibiotics, rendering them inactive. Sulbactam Sodium addresses this resistance by acting as a suicide inhibitor of β-lactamases:
Irreversible Binding: Sulbactam's β-lactam ring binds covalently to the active site of β-lactamase enzymes (especially Class A enzymes, e.g., penicillinase, TEM, SHV).
Enzyme Inactivation: This binding forms a stable, inactive complex, permanently blocking the enzyme from degrading co-administered β-lactam antibiotics.
Spectrum Expansion: By inhibiting β-lactamases, Sulbactam restores the activity of β-lactam antibiotics against strains that would otherwise be resistant (e.g., β-lactam-resistant Staphylococcus aureus, Haemophilus influenzae, Escherichia coli).
Notably, Sulbactam has weak intrinsic antibacterial activity only against Neisseria gonorrhoeae and Haemophilus influenzae-its clinical value lies almost entirely in its adjuvant role with β-lactam antibiotics.
Core Applications (Human & Veterinary Medicine)
Sulbactam Sodium CAS#69388-84-7 is never used alone; it is always combined with β-lactam antibiotics in fixed-dose formulations to treat β-lactam-resistant bacterial infections.
1. Human Pharmaceutical Field
Commonly paired with ampicillin, cefoperazone, or piperacillin, with the most widely used combination being Ampicillin-Sulbactam (1:1 or 2:1 ratio) and Cefoperazone-Sulbactam (1:1 ratio).
1.1 Respiratory Tract Infections
Community-Acquired Pneumonia (CAP): Treats CAP caused by β-lactam-resistant Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis. IV/oral dose (Ampicillin-Sulbactam): 1.5–3 g every 6 hours for 7–14 days.
Chronic Bronchitis Exacerbation: For infections unresponsive to single-agent β-lactams. IV dose (Cefoperazone-Sulbactam): 2–4 g every 12 hours for 5–7 days.
1.2 Skin & Soft Tissue Infections
Cellulitis, Abscesses: Treats infections caused by β-lactam-resistant Staphylococcus aureus (MSSA) or Streptococcus pyogenes. IV/oral dose (Ampicillin-Sulbactam): 1.5–3 g every 6 hours for 7–10 days, paired with surgical debridement if needed.
1.3 Intra-Abdominal & Pelvic Infections
Peritonitis, Cholecystitis: Combats mixed infections (aerobic + anaerobic) with β-lactam-resistant strains (e.g., E. coli, Bacteroides fragilis). IV dose (Piperacillin-Sulbactam): 3.375 g every 6 hours for 10–14 days.
Pelvic Inflammatory Disease (PID): Treats PID caused by β-lactam-resistant Neisseria gonorrhoeae or Chlamydia trachomatis. IV dose (Ampicillin-Sulbactam): 3 g every 6 hours, combined with doxycycline.
1.4 Urinary Tract Infections (UTIs)
Complicated UTIs: For β-lactam-resistant E. coli or Klebsiella pneumoniae. IV/oral dose (Ampicillin-Sulbactam): 1.5–3 g every 6 hours for 7–14 days.
2. Veterinary Field (Livestock & Companion Animals)
Sulbactam Sodium CAS#69388-84-7 is used in combination with ampicillin or amoxicillin for treating bacterial infections in cattle, pigs, and dogs (avoid use in poultry due to residue risks):
Bovine Respiratory Disease (BRD): Caused by β-lactam-resistant Mannheimia haemolytica or Pasteurella multocida. Injectable dose (Ampicillin-Sulbactam): 15–20 mg/kg (based on combined weight) once daily for 3–5 days.
Porcine Respiratory Disease Complex (PRDC): For β-lactam-resistant Actinobacillus pleuropneumoniae. Injectable/oral dose (Amoxicillin-Sulbactam): 10–15 mg/kg once daily for 5–7 days.
Canine Skin Infections (Pyoderma): Caused by β-lactam-resistant Staphylococcus pseudintermedius. Oral dose (Amoxicillin-Sulbactam): 12.5–25 mg/kg twice daily for 7–14 days.
Quality & Safety Assurance
As a critical adjuvant for β-lactam antibiotics, CAS#69388-84-7 requires strict quality control to ensure inhibitor activity, stability, and safety:
1. Manufacturing & Purity Control
Synthesis: Produced via semi-synthetic modification of penicillin G (via oxidation, ring expansion, and salt formation with sodium hydroxide). The process is optimized to:
Preserve the β-lactam ring (critical for inhibitor activity);
Minimize impurities (e.g., penicillin derivatives, oxidation byproducts) to ≤0.5%.
GMP Compliance: Manufactured in Grade C/D cleanrooms (per ICH Q7 guidelines) for pharmaceutical grade, with strict control over moisture levels (to prevent β-lactam ring hydrolysis) during production and packaging.
2. Comprehensive Testing Protocol
| Test Item | Method | Acceptance Criterion |
|---|---|---|
| Purity & Assay | HPLC (C18 column, 220 nm detection) | Purity ≥98.0%; Assay 97.0%–103.0% (as sulbactam) |
| β-Lactamase Inhibitor Activity | Microbiological assay (using β-lactam-resistant S. aureus) | Restores ampicillin activity to resistant strains (zone of inhibition ≥15 mm) |
| Related Substances | HPLC (gradient elution) | Single impurity ≤0.2%; Total impurities ≤0.5% |
| Heavy Metals | ICP-MS (Inductively Coupled Plasma-Mass Spectrometry) | Pb≤10ppm, Hg≤1ppm, Cd≤1ppm |
| Residual Solvents | GC (headspace sampling, FID detector) | Class 2 solvents ≤500ppm; Class 1 solvents not detected |
| Sterility (Injectable Grade) | Membrane filtration method | No bacterial/fungal growth |
3. Safety Reminders
Human Use:
Contraindications: Hypersensitivity to sulbactam, penicillins, or cephalosporins (cross-allergy risk); severe renal impairment (CrCl <30 mL/min-dose reduction required).
Adverse Effects: Common: nausea, diarrhea, rash. Rare but serious: anaphylactic reactions (monitor for wheezing, hypotension), liver enzyme elevation, and hematologic abnormalities (e.g., leukopenia).
Veterinary Use:
Withdrawal Periods: Cattle: 14 days (meat), 48 hours (milk); Pigs: 7 days (meat); Dogs: No withdrawal period (non-food animals).
Residue Warning: Avoid use in laying hens or dairy cattle beyond the withdrawal period to prevent antibiotic residues in eggs/milk.
Cooperation & Contact
We supply Sulbactam Sodium in formulations tailored to combination drug manufacturing:
Pharmaceutical Grade: Fine powder for injectable/oral fixed-dose combinations (1kg–100kg per order, sealed aluminum foil bags with desiccants).
Veterinary Grade: Powder for livestock injectables/oral premixes (10kg–500kg per order; monthly production capacity of 2000kg).
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 fixed-dose combination development (e.g., optimizing ampicillin-sulbactam ratio, ensuring formulation stability).
Inhibitor activity testing (microbiological assays) to validate efficacy against β-lactam-resistant strains.
If you are a pharmaceutical manufacturer, generic drug company, 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 "quality compliance, resistance management, and adjuvant excellence" and look forward to partnering with global healthcare and animal health industries!
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