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Albendazole Raw Material
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Albendazole Raw Material is a broad-spectrum benzimidazole anthelmintic drug substance used as the active pharmaceutical ingredient (API) in human and veterinary medicine. This white to off-white crystalline powder exhibits potent activity against a wide range of parasitic worms including nematodes, cestodes, and trematodes. As a raw material, it meets pharmacopeial standards (USP/EP) with typical purity ≥99.0%. Albendazole works by selectively binding to parasite β-tubulin, inhibiting microtubule polymerization and causing energy depletion in helminths.
Description
Table of Contents
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Albendazole Raw Material
Primary Uses
- Manufacturing of Human Anthelmintic (Deworming) Medication
- Treats intestinal parasites (e.g., roundworms, tapeworms, hookworms).
- Used for neurocysticercosis (brain tapeworm infection) and hydatid disease (liver/lung cysts).
- Manufacturing of Veterinary Medicine
- Deworming livestock (cattle, sheep, goats) and pets (dogs, cats).
- Controls gastrointestinal nematodes and lungworms.
- Pharmaceutical Manufacturing
- Raw material for albendazole tablets, suspensions, and chewables.
Secondary Uses
- Aquaculture
- Occasionally used to treat parasitic infections in fish.
- Research & Development
- Studied for anti-cancer properties (inhibits microtubule formation).
- Agriculture (Limited Use)
- Experimental use as a plant anti-parasitic agent (not widely adopted).
PRODUCT KEY ATTRIBUTES
1. Basic Identification Attributes
- Chemical Name: Methyl [5-(propylthio)-1H-benzimidazol-2-yl]carbamate (IUPAC)
- CAS Number: 54965-21-8
- HS Code: 2933.99.90 (Other heterocyclic compounds)
- Molecular Formula: C₁₂H₁₅N₃O₂S
- Synonyms:
- Albendazol (INN)
- Zentel® (brand name)
- Valbazen® (veterinary brand)
- 5-(Propylthio)-2-carbomethoxyaminobenzimidazole
2. Physical & Chemical Properties
- Physical State: White to off-white crystalline powder
- Color & Odor: White; odorless or faint characteristic odor
- Melting Point: 208-210°C (decomposes)
- Boiling Point: Not applicable (decomposes before boiling)
- Density: ~1.3 g/cm³ (estimated)
- Solubility:
- Water: Practically insoluble (<0.1 mg/mL at 25°C)
- DMSO: Soluble (~50 mg/mL)
- Methanol: Slightly soluble
- Chloroform: Slightly soluble
- pH Level: Neutral (in suspension)
- Vapor Pressure: Negligible at room temperature
- Partition Coefficient (log P): 3.5 (octanol/water)
- Dissociation Constant (pKa): 4.6 (weak base)
3. Safety & Hazard Attributes
- Hazard Class:
- GHS Classification: Harmful if swallowed (H302)
- Not classified as mutagenic or carcinogenic (per IARC)
- NFPA Ratings:
- Health: 2
- Flammability: 1
- Reactivity: 0
- Exposure Limits:
- OSHA PEL: Not established
- ACGIH TLV: Not established
- Reactivity:
- Stable under normal conditions
- Incompatible with strong oxidizing agents
4. Storage & Handling Attributes
- Storage Conditions:
- Store in tightly closed containers
- Temperature: 15-30°C
- Protect from light and moisture
- Incompatible Materials:
- Strong oxidizers
- Strong acids/bases
- Container Type:
- Well-closed glass or polyethylene containers
- Aluminum foil bags for bulk quantities
- Shelf Life:
- Typically 24-36 months when stored properly
- Special Handling:
- Use appropriate PPE (gloves, dust mask, eye protection)
- Avoid dust formation
- Handle in well-ventilated area
5. Regulatory & Compliance Attributes
- Regulatory Status:
- WHO Essential Medicine
- FDA Approved (veterinary and human use)
- EP/JP/USP compliant
- Listed in many national pharmacopeias
- Hazard Symbols:
- GHS07 (Exclamation mark)
- Transportation Restrictions:
- Not classified as dangerous goods for transport
- No UN number required
- Waste Disposal:
- Dispose as pharmaceutical waste
- Incineration recommended
6. Environmental & Health Impact
- Ecotoxicity:
- LC50 (fish): >100 mg/L (practically non-toxic)
- EC50 (daphnia): >100 mg/L
- Persistence:
- Moderately persistent in environment
- DT50 in soil: ~30-60 days
- Carcinogenicity:
- IARC: Not classified
- NTP: Not listed
- EPA: Not classified
- Biodegradability:
- Not readily biodegradable
- Potential to persist in aquatic environments
SAFETY HANDLING
1. Safety Precautions
Personal Protective Equipment (PPE)
- Respiratory Protection: Use an N95 mask or half-face respirator when handling powder to avoid inhalation.
- Eye Protection: Wear safety goggles to prevent eye contact.
- Skin Protection: Use nitrile or chemical-resistant gloves and a lab coat/apron.
- Hygiene Measures: Avoid eating, drinking, or smoking in the work area. Wash hands thoroughly after handling.
Handling & Storage
- Storage: Keep in a cool, dry, well-ventilated area, away from direct sunlight and moisture.
- Avoid Dust Formation: Use closed systems or local exhaust ventilation when transferring powder.
- Incompatibilities: Keep away from strong oxidizers, acids, and bases.
Spill Management
- Small Spills: Dampen with water and collect with an absorbent material (e.g., paper towels).
- Large Spills: Use a HEPA vacuum (do not sweep dry powder).
2. First Aid Measures
Inhalation
- Move to fresh air immediately.
- If breathing is difficult, administer oxygen and seek medical attention.
Skin Contact
- Remove contaminated clothing.
- Wash skin with soap and water for at least 15 minutes.
- If irritation persists, consult a doctor.
Eye Contact
- Rinse immediately with plenty of water for at least 15 minutes (hold eyelids open).
- Seek medical attention if irritation continues.
Ingestion
- Do NOT induce vomiting.
- Rinse mouth and drink plenty of water.
- Seek immediate medical help (albendazole can cause systemic toxicity if ingested in large amounts).
3. Firefighting Measures
Flammability
- Albendazole powder is not highly flammable, but organic dust can combust under certain conditions.
- Auto-Ignition Temperature: Not well-documented, but avoid high heat.
Extinguishing Media
- Small Fires: Use water spray, dry chemical powder, or CO₂.
- Large Fires: Use alcohol-resistant foam or water fog.
Firefighting Precautions
- Wear self-contained breathing apparatus (SCBA) due to potential toxic fumes (e.g., nitrogen oxides, carbon monoxide).
- Cool containers with water spray to prevent rupture.
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