Amprolium Hydrochloride BP USP

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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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Categories: Active Pharmaceutical Ingredients (APIs), AGRICULTURAL CHEMICALS, Animal Feed Additives, PHARMACEUTICAL CHEMICALS Tags: Amprolium HCL, Amprolium hydrochloride, Anticoccidial agent, Livestock feed additive, Pharmaceutical intermediate, Poultry medicine additive

Description

Table of Contents Toggle
- Uses
  - Primary Uses
  - Secondary Uses
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.

PRODUCT KEY FEATURES

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

SAFETY HANDLING PRECAUTIONS

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.