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Chloramphenicol Palmitate Micronised
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.
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.
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
- 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
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