Chloramphenicol Palmitate Micronised

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Chloramphenicol Palmitate Micronised is a micronized, lipophilic ester derivative of chloramphenicol, designed for improved solubility and bioavailability compared to the parent drug. It appears as a fine, white to off-white powder with enhanced surface area due to micronization. This antibiotic is widely used for oral formulations, particularly pediatric suspensions, due to its palatability and controlled release properties. Chloramphenicol Palmitate exhibits broad-spectrum antibacterial activity against both Gram-positive and Gram-negative bacteria. Its ester form offers better stability and reduced bitterness, making it a preferred choice in pharmaceutical preparations.

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Category: Active Pharmaceutical Ingredients (APIs) Tags: Antibiotic ester, Broad-spectrum antibiotic, Chloramphenicol palmitate micronised, Micronized pharmaceutical ingredient, Pharmaceutical active ingredient, White to off-white fine powder

Description

Table of Contents

Chloramphenicol Palmitate Micronised

Primary Uses

Pharmaceutical Industry

Used as an active pharmaceutical ingredient (API) in oral antibiotic formulations such as suspensions and syrups.
Preferred for pediatric use due to improved taste and ease of administration.
Employed for treatment of serious bacterial infections including typhoid fever, meningitis, and respiratory tract infections.
Used in veterinary medicine for similar bacterial infections in animals.

Formulation Benefits

Micronization improves dissolution rate and bioavailability.
The palmitate ester enhances lipophilicity and prolongs drug release, allowing sustained therapeutic levels.

Secondary Uses

Research & Development

Used in pharmaceutical research for developing novel delivery systems and improving drug stability.

Veterinary Medicine

Occasionally used in topical formulations for wound infections in animals.

KEY PRODUCT FEATURES

1. Basic Identification Attributes

Chemical Name (IUPAC): 2,2-Dichloro-N-[(1R,2R)-2-hydroxy-1-(hydroxymethyl)-2-(4-nitrophenyl)ethyl]acetamide palmitate
Common/Trade Name: Chloramphenicol Palmitate Micronised
CAS Number: 552-94-3
HS Code: 2941.90.90
Molecular Formula: C32H48Cl2N2O6
Molecular Weight: 502.65 g/mol
Synonyms:
- Chloramphenicol palmitate
- Chloramphenicol palmitate powder

2. Physical & Chemical Properties

Physical State: Fine white to off-white powder
Color & Odor: White to off-white; odorless or faint medicinal smell
Particle Size: Micronized, typically below 10 microns
Melting Point: ~120–125°C
Solubility:
- Slightly soluble in water
- Soluble in organic solvents like ethanol, chloroform, and acetone
Stability: Stable under recommended storage conditions; sensitive to light and moisture

3. Safety & Hazard Attributes

Hazard Class (GHS): Harmful if swallowed; may cause blood disorders (use with medical supervision)
NFPA Ratings:
- Health: 2
- Flammability: 1
- Reactivity: 0
Exposure Limits: Use with proper ventilation; avoid inhalation of powder
Toxicity: Can cause serious adverse effects including aplastic anemia; restricted for medical use only
Reactivity: Chemically stable; avoid strong oxidizing agents

4. Storage & Handling Attributes

Storage Conditions: Store in a cool, dry place, protected from light and moisture
Container Type: Sealed, airtight containers, preferably amber-colored to protect from light
Shelf Life: 2–3 years if stored properly
Special Handling: Use PPE to avoid inhalation; handle in controlled environments to prevent contamination

5. Regulatory & Compliance Attributes

FDA Status: Approved for specific pharmaceutical uses under prescription
Pharmacopoeia Compliance: USP, BP, EP standards for identity, purity, and potency
REACH Status: Registered
Transportation: Classified as non-hazardous for transport under pharmaceutical regulations
Waste Disposal: Dispose as per medical/pharmaceutical waste regulations

6. Environmental & Health Impact

Ecotoxicity: Low environmental persistence; handle pharmaceutical waste responsibly
Persistence: Biodegradable under environmental conditions
Bioaccumulation: Not expected to bioaccumulate significantly
Carcinogenicity/Mutagenicity: Not classified as carcinogenic; use with medical guidance
Biodegradability: Biodegradable

SAFETY HANDLING PRECAUTIONS

Safety Handling Precautions

PPE: Gloves, lab coat, dust mask or respirator during handling
Handling: Avoid inhalation and contact with skin or eyes; use in well-ventilated areas
Storage: Keep containers tightly closed and protected from light and moisture
Hygiene: Wash hands thoroughly after handling; no eating or drinking during handling

First Aid Measures

Inhalation: Move to fresh air immediately; seek medical advice if symptoms develop
Skin Contact: Wash affected area with soap and water; seek medical advice if irritation occurs
Eye Contact: Rinse thoroughly with water for at least 15 minutes; consult a doctor if irritation persists
Ingestion: Do not induce vomiting; seek immediate medical attention

Firefighting Measures

Fire Hazards: Combustible powder; may decompose to toxic gases when heated
Extinguishing Media: Use water spray, foam, dry chemical, or CO₂
Special Precautions: Firefighters should wear protective gear and respiratory protection
Decomposition Products: May release hydrogen chloride, nitrogen oxides, and carbon monoxide upon burning