Product Basic Information
| Item | Details |
|---|---|
| Product Name | Metronidazole |
| CAS No. | 443-48-1 |
| Synonyms | 2-Methyl-5-nitroimidazole-1-ethanol; Flagyl® (brand name for human oral/IV formulations) |
| Molecular Formula | C₆H₉N₃O₃ |
| Molecular Weight | 171.15 |
| Appearance | White to pale yellow crystalline powder; Odorless or with a slight characteristic odor |
| Specification | - Pharmaceutical Grade: Purity ≥98.5% (HPLC); Melting point 159-163°C; Loss on drying ≤0.5%; Residue on ignition ≤0.1%; Heavy metals (Pb≤10ppm, Hg≤1ppm, Cd≤1ppm)- Veterinary Grade: Purity ≥95.0% (HPLC); Compliant with EP Vet/USP Vet; No detectable nitroimidazole impurities (≤0.1%) |
| Melting Point | 159-163°C |
| Solubility | Slightly soluble in water (≈1 g/L at 25°C); Soluble in ethanol, methanol, and dilute acids/bases; Sparingly soluble in chloroform |
| Storage Conditions | Store in a cool (15-25°C), dry, light-protected container; Sealed to prevent moisture absorption and photodegradation (nitro group is light-sensitive); Shelf life: 36 months for pharmaceutical grade, 24 months for veterinary grade |
Core Functions & Applications
Metronidazole CAS#443-48-1 exerts its antimicrobial effect by entering anaerobic bacteria or protozoa, where its nitro group is reduced by microbial nitroreductase enzymes (active only in anaerobic environments). The reduced form damages microbial DNA (via formation of reactive oxygen species and DNA cross-linking), leading to cell death. It has no activity against aerobic or facultative anaerobic bacteria, making it highly specific for anaerobic pathogens. It is used in both human medicine and veterinary practice:
1. Human Pharmaceutical Field
1.1 Anaerobic Bacterial Infections
Intra-Abdominal Infections: First-line treatment for peritonitis, abscesses (liver, pelvic), and appendicitis caused by Bacteroides fragilis (the most common anaerobic pathogen in the gut). Administered as IV infusion (500 mg every 8 hours) or oral tablets (500 mg every 6 hours) for 7-14 days, often combined with a Gram-negative aerobic antibiotic (e.g., ceftriaxone).
Skin & Soft Tissue Infections: Treats necrotizing fasciitis, diabetic foot ulcers, and wound infections with anaerobic involvement (e.g., Clostridium perfringens, Peptostreptococcus spp.). Oral/IV dose: 500 mg every 6-8 hours for 10-14 days, paired with surgical debridement if needed.
Respiratory Tract Infections: Used for aspiration pneumonia and lung abscesses caused by anaerobic oral flora (e.g., Prevotella spp.). IV dose: 500 mg every 8 hours for 7-10 days, switching to oral once clinical improvement occurs.
1.2 Parasitic Infections
Trichomoniasis: The gold standard for treating genital trichomoniasis (caused by Trichomonas vaginalis), a common sexually transmitted infection (STI). Single oral dose of 2 g (or 500 mg twice daily for 7 days) for both partners, with cure rates >95%.
Giardiasis: Treats intestinal giardiasis (caused by Giardia lamblia)-a leading cause of traveler's diarrhea. Oral dose: 250 mg three times daily for 5-7 days (adults) or 15 mg/kg/day divided into 3 doses (children), resolving diarrhea and abdominal cramps.
Amebiasis: Effective for intestinal amebiasis (diarrhea caused by Entamoeba histolytica) and extraintestinal amebiasis (liver abscess). Oral dose: 500-750 mg three times daily for 5-10 days (intestinal) or 7-14 days (liver abscess).
1.3 Other Infections
Helicobacter pylori Eradication: Part of triple/quadruple therapy for H. pylori (causes peptic ulcers, gastric cancer). Typical dose: 500 mg twice daily for 7-14 days, combined with a proton pump inhibitor (e.g., omeprazole) and a penicillin (e.g., amoxicillin).
2. Veterinary Field
2.1 Companion Animals (Dogs, Cats)
Anaerobic Infections:
Canine pyoderma (skin infections) and feline oral abscesses caused by Bacteroides spp. or Clostridium spp. Oral tablets: 10-20 mg/kg body weight twice daily for 7-14 days.
Canine inflammatory bowel disease (IBD) with anaerobic overgrowth: Low-dose oral administration (5-10 mg/kg once daily) for 4-6 weeks to reduce intestinal inflammation.
Parasitic Infections:
Canine giardiasis (caused by Giardia duodenalis): Oral dose (25 mg/kg body weight twice daily for 5 days) to eliminate cysts and resolve diarrhea.
Feline trichomoniasis (intestinal, caused by Tritrichomonas foetus): Oral dose (10-15 mg/kg twice daily for 14 days), though resistance may require combination therapy.
2.2 Livestock (Cattle, Pigs)
Anaerobic Infections:
Bovine foot rot (caused by Fusobacterium necrophorum) and porcine necrotic enteritis (caused by Clostridium perfringens). Injectable solution (10 mg/kg body weight once daily for 3-5 days) or oral premixes (20-40 mg/kg feed) for group prevention.
Parasitic Infections:
Bovine trichomoniasis (genital, caused by Tritrichomonas foetus-a cause of abortion). Injectable dose (5 mg/kg body weight once) for bulls, reducing pathogen shedding.
Quality & Safety Assurance
Metronidazole's specificity and widespread use require strict quality control to ensure efficacy, minimize toxicity, and prevent residue risks in food animals:
Raw Material & Synthesis: Produced via chemical synthesis (condensation of 2-methylimidazole with ethylene oxide, followed by nitration) and purified via recrystallization. Raw materials meet USP/EP standards for impurity limits (e.g., 2-methylimidazole ≤0.1%, a starting material impurity).
Production Process:
Pharmaceutical Grade: Manufactured in GMP-certified workshops (Class D cleanroom for final processing) with photoprotective equipment to avoid light-induced degradation of the nitro group.
Veterinary Grade: Undergoes additional testing for residue markers (e.g., metronidazole metabolites ≤0.01 ppm in edible tissues) and complies with veterinary pharmacopoeia standards.
Comprehensive Testing Protocol:
| Test Item | Method | Acceptance Criterion |
|---|---|---|
| Purity & Assay | HPLC (C18 column, 277 nm detection) | Pharmaceutical grade: ≥98.5% purity; Veterinary grade: ≥95.0% purity |
| Related Substances | HPLC (gradient elution) | Single impurity ≤0.5%, total impurities ≤1.0% |
| Heavy Metals | ICP-MS (Inductively Coupled Plasma-Mass Spectrometry) | Pb≤10ppm, Hg≤1ppm, Cd≤1ppm |
| Residue Solvents | GC (headspace sampling) | Ethanol ≤5000ppm, Acetone ≤500ppm |
| Sterility (Injectable Grade) | Membrane filtration method | No bacterial/fungal growth |
Safety Reminders:Human Use:
Contraindications: Hypersensitivity to nitroimidazoles; first trimester of pregnancy (Category B in second/third trimester-avoid if possible); alcohol use (disulfiram-like reaction: flushing, vomiting, hypotension).
Adverse Effects: Gastrointestinal discomfort (nausea, metallic taste), headache, and rare neurotoxicity (peripheral neuropathy, seizures-discontinue if symptoms occur).
Veterinary Use:
Withdrawal Periods: Cattle: 28 days (meat), 96 hours (milk); Pigs: 14 days (meat); Dogs/Cats: No withdrawal period (non-food animals).
Contraindications: Avoid in pregnant animals (may cause fetal harm) and animals with hepatic impairment (reduced metabolism increases toxicity).
Cooperation & Contact
We supply Metronidazole CAS#443-48-1 in multiple grades and formulations to meet diverse needs:
Pharmaceutical Grade: Raw powder for oral tablets, capsules, IV injections, and topical gels (1kg-100kg per order).
Veterinary Grade: Raw powder for injectables, oral suspensions, and premixes (10kg-500kg per order; monthly production capacity of 800kg).
Value-added services include:
Providing DMF (Drug Master File) and CEP (Certificate of Suitability) for pharmaceutical-grade products to support registration in the EU, US, and Asia.
Customized formulation support (e.g., taste masking for companion animal oral suspensions, solubility enhancement for IV solutions).
Technical guidance on anaerobic infection management (human/veterinary clients) and residue avoidance in food animals.
If you are a pharmaceutical manufacturer, veterinary drug enterprise, or companion animal health company, please contact us for detailed cooperation:
Contact Information:
Email: sales@huarongpharma.com
Phone/WhatsApp: +86 13751168070
We adhere to the principles of "quality compliance, safety priority, and targeted therapy" and look forward to partnering with global healthcare and animal health enterprises!
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