Amprolium Hydrochloride BP USP
Amprolium Hydrochloride is a white, odorless, crystalline powder used primarily as a coccidiostat, which means it inhibits the growth of Eimeria species (protozoan parasites) responsible for coccidiosis in poultry and other animals. It works by mimicking thiamine (vitamin B1), thereby competitively inhibiting thiamine uptake by the parasite, disrupting its metabolism, and preventing its proliferation. Amprolium HCl is widely used in veterinary medicine, especially in poultry farming, and is often included in feed or drinking water. It complies with BP 2008 and USP 32 pharmacopeial standards.
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Uses
Primary Uses
Veterinary Medicine – Coccidiostat
- Poultry (chickens, turkeys, ducks):
- Used for prevention and treatment of coccidiosis, a major parasitic disease affecting intestinal health and feed efficiency.
- Administered via feed or drinking water either continuously or in specific programs.
- Effective against Eimeria tenella, E. necatrix, E. acervulina, and other species.
- Calves, Lambs, Goats, Rabbits, and other livestock:
- Used to prevent or treat protozoal infections, especially in young or weaning animals.
Veterinary Formulations
- Incorporated into premixes, soluble powders, oral solutions, and sometimes injectables.
- Can be used alone or in combination with other agents (e.g., sulfonamides, vitamins).
- Included in preventive health protocols in large-scale farming systems.
Secondary Uses
Pharmaceutical Ingredient in Animal Drug Manufacturing
- Used as an API (Active Pharmaceutical Ingredient) in licensed veterinary medicinal products (VMPs).
- Sometimes incorporated in multi-component formulations with electrolytes or other antiparasitic agents.
Agricultural & Research Applications
- Used in parasitological studies for inducing or preventing coccidial infections in laboratory settings.
- Employed in diagnostic research to evaluate coccidia resistance or drug efficacy.
Ornamental Birds & Game Birds
- Occasionally used under veterinary supervision in aviaries, pet birds, and game birds like quail and pheasants.
1. Basic Identification Attributes
- Chemical Name (IUPAC): 1-[(4-Amino-2-propylpyrimidin-5-yl)methyl]-2-methylpyridinium chloride
- Common/Trade Names: Amprolium HCl, Amprolium Hydrochloride
- CAS Number: 137-88-2
- HS Code: 2933.59.95
- Molecular Formula: C₁₄H₁₉ClN₄
- Molecular Weight: 278.78 g/mol
- Synonyms: Amprolium monohydrochloride, Amprol, Coccidiostat HCl
2. Physical & Chemical Properties
- Appearance: White to off-white crystalline powder
- Odor: Odorless
- Solubility: Freely soluble in water; practically insoluble in ethanol or ether
- Melting Point: 165–170°C (decomposes)
- pH (1% solution): 4.5–5.5
- Stability: Stable under recommended storage conditions; may degrade under strong light or humidity
- Particle Size: Can be micronized for uniform feed mixing
- Bulk Density: ~0.45–0.60 g/cm³
3. Safety & Hazard Attributes
- GHS Classification: Not classified as hazardous
- NFPA Ratings:
- Health: 1 (low hazard)
- Flammability: 0 (non-flammable)
- Reactivity: 0 (stable)
- Toxicity:
- Oral LD₅₀ (rat): ~3,000 mg/kg (low acute toxicity)
- Non-teratogenic, non-mutagenic in standard tests
- Reactivity: Stable under normal conditions; avoid mixing with oxidizers
- Incompatibilities: Strong oxidizing agents, strong acids or bases
4. Storage & Handling Attributes
- Storage Conditions:
- Store in tightly sealed containers
- Keep in a cool, dry, well-ventilated place
- Protect from light and moisture
- Shelf Life: 3–5 years under proper storage
- Packaging Types:
- HDPE drums, fiber drums with PE liners, laminated foil bags
- Handling Precautions:
- Avoid inhalation of dust; use appropriate PPE (gloves, goggles, dust mask)
5. Regulatory & Compliance Attributes
- Pharmacopoeia Standards:
- BP 2008 Compliant
- USP 32 Compliant
- Veterinary Approval:
- Approved by FDA (USA), EMA (EU), and other international veterinary authorities
- Residue Limits (MRLs):
- MRLs vary by species and jurisdiction; withdrawal periods required before slaughter
- Transportation:
- Not classified as hazardous for transport
- Waste Disposal:
- Dispose of in accordance with local environmental and pharmaceutical regulations
6. Environmental & Health Impact
- Ecotoxicity:
- Low toxicity to aquatic life at typical usage levels
- Must avoid direct discharge into water bodies
- Persistence:
- Biodegradable under aerobic conditions
- Bioaccumulation:
- Low potential for bioaccumulation
- Public Health Risk:
- Requires veterinary supervision to avoid resistance or misuse
- Carcinogenicity/Mutagenicity:
- Not classified as carcinogenic or mutagenic
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Safety Handling Precautions
- PPE Requirements:
- Wear protective gloves, lab coat, goggles, and dust mask or respirator when handling powders.
- Hygiene Measures:
- Do not eat, drink, or smoke while handling.
- Wash hands thoroughly after use.
First Aid Measures
- Inhalation:
- Move to fresh air. Seek medical attention if symptoms persist.
- Skin Contact:
- Wash with soap and water. Remove contaminated clothing.
- Eye Contact:
- Rinse thoroughly with water for at least 15 minutes.
- Ingestion:
- Rinse mouth with water. Do not induce vomiting. Seek medical help.
Firefighting Measures
- Flammability:
- Non-flammable solid
- Extinguishing Media:
- Use dry chemical, CO₂, water spray, or foam
- Special Precautions:
- Avoid dust inhalation; use SCBA in confined areas
- Thermal Decomposition:
- May release nitrogen oxides, carbon monoxide