Colistin Sulphate BP

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Colistin Sulphate BP is an antibiotic belonging to the polymyxin class, derived from the bacterium Paenibacillus polymyxa. It is a white to pale yellow powder, soluble in water, and used primarily for its potent bactericidal activity against Gram-negative bacteria, including multidrug-resistant strains. Colistin Sulphate BP is used in both human and veterinary medicine, often as a last-resort treatment for serious infections caused by multidrug-resistant Pseudomonas, Acinetobacter, and Klebsiella species. Due to its efficacy and narrow therapeutic index, its use is carefully monitored. The “BP” denotes compliance with the British Pharmacopoeia standards.

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Category: Active Pharmaceutical Ingredients (APIs) Tags: Antibiotic API, Broad-spectrum antimicrobial, Colistin sulphate BP, Pharmaceutical ingredient, White to off-white powder

Description

Table of Contents

Colistin Sulphate BP

Primary Uses

Human Medicine

Used as a critical antibiotic for treating serious infections caused by multidrug-resistant Gram-negative bacteria, including pneumonia, bloodstream infections, urinary tract infections, and sepsis.
Administered orally or by inhalation for intestinal decontamination and respiratory infections, respectively, and by injection or nebulization under clinical supervision.
Often reserved for cases where other antibiotics have failed due to its toxicity profile and potential for resistance development.

Veterinary Medicine

Employed to treat infections in livestock and poultry caused by Gram-negative bacteria.
Used as a feed additive or therapeutic agent under strict regulations to manage bacterial infections and promote animal health.
Plays a role in preventing and controlling enteric infections, especially in pigs and poultry farming.

Secondary Uses

Research & Development

Utilized in microbiological research as a selective agent in culture media to isolate and study Gram-negative bacteria.
Investigated for novel drug delivery systems and combination therapies to enhance efficacy and reduce toxicity.

Agricultural Applications

Occasionally explored for soil treatment to manage bacterial contamination, though use is limited due to environmental and resistance concerns.

KEY PRODUCT FEATURES

1. Basic Identification Attributes

Chemical Name (IUPAC): Mixture of polymyxin E1 and E2 sulfate salts
Common/Trade Name: Colistin Sulphate BP
CAS Number: 1264-72-8
HS Code: 2941.00.00
Molecular Formula: Variable mixture (complex cyclic peptides)
Synonyms:
- Polymyxin E Sulfate
- Colistin

2. Physical & Chemical Properties

Physical State: Fine, white to pale yellow powder
Color & Odor: Pale yellow; almost odorless
Melting Point: Decomposes before melting
Solubility: Soluble in water (freely soluble in dilute acids)
pH (1% solution): Typically 4.5–7.5
Stability: Stable under recommended storage; sensitive to light and moisture

3. Safety & Hazard Attributes

Hazard Class (GHS): Harmful if swallowed, skin irritant, eye irritant
NFPA Ratings:
- Health: 2
- Flammability: 0
- Reactivity: 0
Exposure Limits: No specific occupational exposure limit, but use with caution to avoid inhalation or skin contact
Toxicity: Nephrotoxic and neurotoxic at high doses; monitor therapeutic levels strictly
Reactivity: Stable under normal conditions

4. Storage & Handling Attributes

Storage Conditions: Store in a cool, dry place away from light and moisture
Container Type: Airtight, moisture-proof containers or pharmaceutical-grade packaging
Shelf Life: Typically 2–3 years under proper storage
Special Handling: Use gloves and mask; avoid inhalation of powder; handle in well-ventilated areas

5. Regulatory & Compliance Attributes

BP Compliance: Meets British Pharmacopoeia quality standards
FDA Status: Approved for specific medical uses; strictly prescription-based
Veterinary Regulations: Use regulated by authorities to limit resistance development
Transportation: Classified as non-hazardous for transport under normal conditions
Waste Disposal: Dispose as pharmaceutical waste per local regulations

6. Environmental & Health Impact

Ecotoxicity: Potentially toxic to aquatic organisms; avoid environmental contamination
Persistence: Moderately persistent in the environment
Bioaccumulation: Low potential for bioaccumulation
Carcinogenicity/Mutagenicity: Not classified as carcinogenic or mutagenic
Biodegradability: Biodegradable under controlled conditions

SAFETY HANDLING PRECAUTIONS

Safety Handling Precautions

Personal Protective Equipment (PPE):

Gloves, lab coat, and dust mask or respirator when handling powder
Eye protection to avoid dust contact

Handling Measures:

Avoid inhalation of dust and contact with skin or eyes
Use in well-ventilated areas or fume hoods

Storage Measures:

Keep container tightly closed
Store away from incompatible substances such as strong oxidizers

Hygiene Practices:

Wash hands thoroughly after handling
Do not eat, drink, or smoke in areas where product is handled

First Aid Measures

Inhalation: Move to fresh air immediately; seek medical attention if breathing difficulty occurs
Skin Contact: Wash skin thoroughly with soap and water; remove contaminated clothing; seek medical advice if irritation persists
Eye Contact: Rinse eyes with plenty of water for 15 minutes; seek immediate medical attention
Ingestion: Do not induce vomiting; seek emergency medical care immediately

Firefighting Measures

Fire Hazards: Non-flammable; however, may decompose at high temperatures producing toxic fumes
Extinguishing Media: Use water spray, foam, dry chemical, or CO₂ extinguisher
Special Precautions: Firefighters should wear self-contained breathing apparatus and protective gear
Decomposition Products: Carbon oxides, nitrogen oxides, sulfur oxides, and other toxic gases