Ampicillin Sodium (Sterile, CAS No.: 69-52-3) - Broad-Spectrum Penicillin Antibacterial for Parenteral Therapy

As a professional supplier of pharmaceutical-grade sterile antibacterial active ingredients, we provide high-purity Sterile Ampicillin Sodium that strictly complies with global pharmacopoeia standards (USP, EP, BP, CP). A first-generation semi-synthetic penicillin, it exhibits broad-spectrum bactericidal activity against Gram-positive and Gram-negative bacteria. The sterile grade is specifically formulated for parenteral administration (IV injection, IM injection)-critical for treating severe bacterial infections where oral therapy is impractical or ineffective. It is widely used in human medicine for acute infections and in select veterinary practice for livestock and companion animals, serving as a foundational agent in antibacterial therapy.

Product Basic Information

Core Functions & Mechanism of Action

Sterile Ampicillin Sodium exerts a bactericidal effect by interfering with bacterial cell wall synthesis-its mechanism is characteristic of penicillin-class antibiotics:

Target Binding: Ampicillin binds to penicillin-binding proteins (PBPs) on the bacterial cell membrane. PBPs are enzymes critical for cross-linking peptidoglycan (the structural component of bacterial cell walls).

Cell Wall Disruption: By inhibiting PBP activity, ampicillin prevents peptidoglycan cross-linking, leading to weakened cell walls.

Bacterial Lysis: Weakened cell walls cannot withstand osmotic pressure, causing bacterial cells to swell and lyse (die).

Key advantages of ampicillin over natural penicillins (e.g., penicillin G):

Broadened spectrum: Active against Gram-positive bacteria (e.g., Streptococcus pneumoniae, Staphylococcus aureus [MSSA]) and Gram-negative bacteria (e.g., Escherichia coli, Haemophilus influenzae, Salmonella spp.).

Activity against enteric Gram-negatives: Effective against common gut bacteria, making it useful for urinary tract and gastrointestinal infections.

Core Applications

Sterile Ampicillin Sodium CAS#69-52-3 is reserved for moderate-to-severe bacterial infections requiring parenteral delivery (e.g., patients with sepsis, inability to swallow, or severe dehydration). It is not active against viral infections (e.g., cold/flu) or β-lactamase-producing bacteria (requires combination with a β-lactamase inhibitor like sulbactam).

1. Human Pharmaceutical Field

1.1 Respiratory Tract Infections

Community-Acquired Pneumonia (CAP): Treats CAP caused by penicillin-sensitive S. pneumoniae or H. influenzae (non-β-lactamase-producing strains). IV/IM dose: 0.5–1 g every 6 hours for 7–14 days.

Acute Bronchitis Exacerbation: For bacterial superinfection in patients with chronic obstructive pulmonary disease (COPD). IV dose: 1 g every 6 hours for 5–7 days.

1.2 Urinary Tract Infections (UTIs)

Complicated UTIs & Pyelonephritis: Treats kidney or urinary tract infections caused by susceptible E. coli, Klebsiella pneumoniae, or Enterococcus faecalis. IV dose: 1–2 g every 6 hours for 10–14 days.

Septicemia from UTI: For bloodstream infections secondary to UTIs. IV dose: 2 g every 4–6 hours for 14–21 days, adjusted for renal function.

1.3 Gastrointestinal & Intra-Abdominal Infections

Typhoid Fever: Treats typhoid caused by Salmonella typhi. IV dose: 2 g every 6 hours for 14 days (alternative to fluoroquinolones in drug-sensitive cases).

Biliary Tract Infections (Cholecystitis, Cholangitis): For susceptible E. coli or Klebsiella spp. IV dose: 1–2 g every 6 hours for 7–10 days.

1.4 Other Infections

Meningitis: Treats meningitis caused by penicillin-sensitive S. pneumoniae or Neisseria meningitidis (in combination with other antibiotics). IV dose: 2–4 g every 4 hours for 14 days.

Septic Arthritis: For joint infections caused by Streptococcus spp. IV dose: 1–2 g every 6 hours for 3–4 weeks.

2. Veterinary Field (Livestock & Companion Animals)

Sterile Ampicillin Sodium CAS#69-52-3 is used for injectable treatment of bacterial infections in cattle, pigs, sheep, and dogs:

Bovine Respiratory Disease (BRD): Caused by susceptible Pasteurella multocida or Mannheimia haemolytica. IM dose: 7–10 mg/kg body weight once daily for 3–5 days.

Porcine Neonatal Diarrhea: For E. coli-induced scours in piglets. IM dose: 5–10 mg/kg once daily for 3 days.

Canine Pyoderma & UTIs: For susceptible Staphylococcus pseudintermedius (skin) or E. coli (UTIs). IM dose: 10–20 mg/kg twice daily for 7–14 days.

Contraindications: Never use in poultry (high residue risk) or animals with penicillin hypersensitivity.

Quality & Safety Assurance

As a sterile parenteral antibiotic, CAS#69-52-3 undergoes rigorous quality control to ensure sterility, efficacy, and safety:

1. Manufacturing & Sterility Control

Synthesis & Sterilization: Produced via semi-synthetic modification of penicillin G, followed by aseptic processing or terminal sterilization (autoclaving, validated to maintain potency). The process ensures:

No microbial contamination (sterility test compliant with USP <71> / EP 2.6.1);

Low endotoxin levels (≤0.25 EU/mg, critical for parenteral use to avoid sepsis).

GMP Compliance: Manufactured in Grade A/B cleanrooms (per ICH Q7 guidelines) with HEPA filtration, strict gowning protocols, and environmental monitoring (air/surface microbial counts).

2. Comprehensive Testing Protocol

3. Safety Reminders

Human Use:

Contraindications: Hypersensitivity to penicillins or cephalosporins (cross-allergy risk); severe renal impairment (CrCl <30 mL/min-dose reduction required); infectious mononucleosis (risk of rash).

Adverse Effects: Common: rash, nausea, diarrhea. Rare but serious: anaphylactic shock (administer epinephrine immediately), pseudomembranous colitis (caused by Clostridioides difficile), and hematologic abnormalities (e.g., thrombocytopenia).

Veterinary Use:

Withdrawal Periods: Cattle: 14 days (meat), 48 hours (milk); Pigs: 7 days (meat); Sheep: 10 days (meat).

Residue Warning: Avoid use in lactating dairy cattle beyond the withdrawal period to prevent antibiotic residues in milk.

Cooperation & Contact

We supply Sterile Ampicillin Sodium in sterile packaging tailored to parenteral use:

Pharmaceutical Sterile Grade: 1g, 2g, 5g, or 10g vials (amber glass, rubber stoppers, aluminum seals) for hospital IV/IM formulations (1kg–100kg per order).

Veterinary Sterile Grade: 50g, 100g, or 500g sterile bags for livestock injectables (10kg–500kg per order; monthly production capacity of 3000kg).

Value-added services include:

Providing DMF (Drug Master File) and CEP (Certificate of Suitability) for pharmaceutical-grade products to support EU/US/Asia registration.

Sterility validation documentation (for regulatory compliance) and technical support for injectable formulation development (e.g., reconstitution stability).

Batch-specific COA (Certificate of Analysis) with endotoxin and sterility test results.

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 "sterile quality, parenteral safety, and antibacterial efficacy" and look forward to partnering with global healthcare and animal health industries!

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