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Miconazole Nitrate BP
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Miconazole Nitrate BP is a high-purity, pharmaceutical-grade antifungal agent conforming to British Pharmacopoeia (BP) specifications. It is widely used in the formulation of topical and oral pharmaceutical products for the treatment of fungal infections caused by dermatophytes and yeasts, including Candida species. Miconazole Nitrate functions by inhibiting the biosynthesis of ergosterol, a vital component of fungal cell membranes, leading to cell death.
This white to off-white crystalline powder is highly effective and exhibits broad-spectrum antifungal and some antibacterial activity. It is commonly utilized in creams, ointments, powders, and gel formulations.
Description
Miconazole Nitrate BP
Primary UsesÂ
- Antiprotozoal Therapy
- Treatment of amoebiasis (intestinal and hepatic).
- Management of giardiasis (Giardia lamblia infections).
- Used in trichomoniasis (vaginal and urethral infections).
- Antibacterial Therapy
- Active against anaerobic bacteria (e.g., Bacteroides, Clostridium).
- Used in bacterial vaginosis and pelvic inflammatory disease (PID).
- Prophylaxis in colorectal and gynecological surgeries.
- Helicobacter pylori Eradication
- Part of triple/quadruple therapy for peptic ulcers.
Secondary UsesÂ
- Veterinary Medicine
- Treatment of anaerobic infections in dogs and cats.
- Used in fish farming to control protozoan parasites.
- Dermatology
- Topical formulations for rosacea and acneiform eruptions.
- Dental Infections
- Adjunct therapy for acute necrotizing ulcerative gingivitis (ANUG).
KEY PRODUCT FEATURES
Key Attributes
Basic Identification Attributes
- Chemical Name (IUPAC): 2-Methyl-5-nitro-1H-imidazole-1-ethanol benzoate
- Common/Trade Name: Metronidazole Benzoate BP
- CAS Number: 13182-89-3
- HS Code: 2933.29.90 (Other heterocyclic compounds)
- Synonyms: Metronidazole benzoate ester; Flagyl benzoate
Physical & Chemical Properties
- Physical State: White to pale yellow crystalline powder
- Color & Odor: Odorless or faint characteristic odor
- Melting Point: ~98–102°C
- Solubility:
- Slightly soluble in water
- Freely soluble in methanol, ethanol, chloroform
- pH: Neutral (~6.0–7.5 in suspension)
Safety & Hazard Attributes
- GHS Classification:
- H302 (Harmful if swallowed)
- H315 (Causes skin irritation)
- H319 (Causes serious eye irritation)
- H335 (May cause respiratory irritation)
- Toxicity: Low acute toxicity; avoid prolonged exposure
- Exposure Limits: No specific OEL; handle as pharmaceutical powder
Storage & Handling Attributes
- Storage Conditions:
- Store in tightly sealed containers at ≤25°C.
- Protect from light and moisture.
- Container Type: Amber glass or HDPE containers.
- Shelf Life: Typically 24–36 months if stored properly.
- Handling Precautions:
- Use gloves, mask, and goggles.
- Avoid dust formation.
Regulatory & Compliance Attributes
- Complies with:
- British Pharmacopoeia (BP) standards.
- USP/NF (if applicable for formulations).
- ICH Q7 (GMP for APIs).
- Regulatory Status:
- Prescription-only drug in most countries.
SAFETY HANDLING PRECAUTIONS
Environmental & Health Impact
- Biodegradability: Readily biodegradable.
- Ecotoxicity: Low risk; no significant bioaccumulation.
- Carcinogenicity/Mutagenicity:
- Not classified (metronidazole is a possible carcinogen with chronic exposure).
Safety Handling Precautions
- PPE Required:
- Nitrile gloves, dust mask, lab coat, safety goggles.
- Handling Guidelines:
- Use in well-ventilated areas.
- Avoid contact with skin/eyes.
- Storage Measures:
- Keep away from strong oxidizers.
First Aid Measures
- Inhalation: Move to fresh air; seek medical help if irritation persists.
- Skin Contact: Wash with soap and water; remove contaminated clothing.
- Eye Contact: Rinse with water for 15 mins; consult ophthalmologist.
- Ingestion: Rinse mouth; do NOT induce vomiting; seek medical attention.
Firefighting Measures
- Fire Hazards: Non-flammable but may decompose at high temperatures.
- Extinguishing Media: Use water spray, COâ‚‚, or dry chemical.
- Hazardous Combustion Products: Nitrogen oxides (NOx), CO, COâ‚‚.
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Metronidazole Benzoate BP is a benzoate ester derivative of metronidazole, used primarily as an antiprotozoal and antibacterial agent. It is a prodrug that hydrolyzes in the body to release metronidazole, making it more palatable for pediatric and geriatric oral suspensions. It complies with the British Pharmacopoeia (BP) standards for purity and efficacy.
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