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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.

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Category: Active Pharmaceutical Ingredients (APIs) Tags: Albendazole raw material, Human medicine API, Parasite control drug component, Pharmaceutical Manufacturing, Veterinary drug API

Description

Table of Contents

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).

KEY PRODUCT FEATURES

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 PRECAUTIONS

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).

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).

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.