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Betamethasone Sodium Phosphate BP
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Betamethasone Sodium Phosphate BP is a synthetic corticosteroid ester in its water-soluble sodium salt form. It is widely used for its strong anti-inflammatory and immunosuppressive properties in medical and veterinary applications. It is typically formulated as an injectable or ophthalmic solution to manage acute or chronic inflammatory and autoimmune conditions, including severe allergic reactions, asthma, arthritis, and dermatological disorders. Its rapid onset of action and high potency make it valuable in emergency and systemic therapy.
Description
Primary UsesÂ
Pharmaceutical Applications
- Injectable Corticosteroid: Used in intramuscular, intravenous, intra-articular, and intralesional injections for acute and severe inflammatory disorders (e.g., rheumatoid arthritis, lupus, multiple sclerosis, anaphylaxis).
- Endocrine Disorders: Used to treat adrenal insufficiency or congenital adrenal hyperplasia.
- Dermatologic Conditions: Effective in managing severe allergic dermatoses and skin conditions such as pemphigus or psoriasis.
- Respiratory Treatment: Used in the management of asthma and severe allergic rhinitis.
- Ophthalmic & Otic Preparations: Included in eye and ear drops to reduce inflammation caused by infections or injuries.
- Gastrointestinal Disorders: Administered for inflammatory bowel disease (Crohn’s disease, ulcerative colitis).
- Hematological Disorders: Used in the management of leukemias and lymphomas.
Veterinary Use
- Administered to animals for the treatment of inflammatory and allergic conditions in dogs, cats, and horses.
Secondary Uses
- Organ Transplantation: Occasionally used as part of immunosuppressive therapy post-transplant to prevent rejection.
- Adjunct Therapy: Combined with antibiotics to manage severe infections involving inflammation.
- Diagnostic Aid: Employed in adrenal function testing due to its corticosteroid action.
PRODUCT KEY FEATURES
. Basic Identification Attributes
- Chemical Name (IUPAC): Disodium (11β,16β)-9-fluoro-11,17-dihydroxy-16-methyl-3,20-dioxopregna-1,4-dien-21-yl phosphate
- Common/Trade Names: Betamethasone Sodium Phosphate, BSP, Celestone Phosphate
- CAS Number: 151-73-5
- HS Code: 2937.29.00
- Molecular Formula: C₂₂H₂₈FNa₂O₈P
- Synonyms:
- Betamethasone disodium phosphate
- Betamethasone 21-phosphate sodium
- BSP Sodium salt
2. Physical & Chemical Properties
- Physical State: White to off-white crystalline powder
- Color & Odor: Odorless; white to cream-colored
- Solubility: Freely soluble in water, slightly soluble in alcohol
- Melting Point: 220–230°C (with decomposition)
- pH (1% solution): ~7.0–9.0
- Stability: Stable under recommended storage; moisture sensitive
- Reactivity: Stable under normal conditions; avoid strong oxidizers
3. Safety & Hazard Attributes
- Hazard Class (GHS): Not classified as hazardous in diluted pharmaceutical use
- NFPA Ratings:
- Health: 2 (may cause organ effects with prolonged exposure)
- Flammability: 0
- Reactivity: 0
- Exposure Limits: No established OSHA/ACGIH limits
- Toxicity: Can cause adrenal suppression, immunosuppression, or metabolic effects with long-term or high-dose exposure
- Carcinogenicity: Not classified as carcinogenic
4. Storage & Handling Attributes
- Storage Conditions: Store at 15–25°C in airtight, moisture-proof containers
- Container Type: HDPE bottles, amber glass vials for solutions
- Shelf Life: 2–3 years (if stored properly)
- Special Handling: Avoid moisture and direct light; wear gloves and eye protection when handling bulk material
5. Regulatory & Compliance Attributes
- BP (British Pharmacopoeia): Complies with BP specifications for purity and assay
- FDA/EMA Status: Approved active pharmaceutical ingredient (API) in various formulations
- Transport Classification: Not classified as a hazardous substance for transport
- Waste Disposal: Dispose of according to local pharmaceutical waste regulations
6. Environmental & Health Impact
- Ecotoxicity: Not expected to be harmful in low environmental concentrations
- Persistence: Not readily biodegradable
- Bioaccumulation: Low potential
- Mutagenicity: No known mutagenic effects
- Endocrine Disruption: May affect hormone levels with prolonged environmental exposure
SAFETY HANDLING PRECAUTIONS
-
Safety Handling Precautions
- PPE: Use gloves, lab coat, and eye protection; use NIOSH-approved respirator for bulk powder.
- Dust Control: Avoid generation of dust; handle in fume hood or under local exhaust ventilation.
- Hygiene Measures: Avoid ingestion, inhalation, and skin contact. Wash hands thoroughly after handling.
- Spill Management: Collect spilled powder using damp cloth or HEPA vacuum; do not dry sweep.
First Aid Measures
- Inhalation: Remove to fresh air. Seek medical attention if respiratory symptoms persist.
- Skin Contact: Wash thoroughly with soap and water. Seek medical advice if irritation develops.
- Eye Contact: Rinse immediately with water for at least 15 minutes. Get medical attention.
- Ingestion: Rinse mouth. Seek medical advice, especially if large quantities are ingested.
Firefighting Measures
- Fire Hazards: Non-flammable; may decompose under fire to produce toxic fumes (e.g., carbon monoxide, fluorinated compounds).
- Extinguishing Media: Use water spray, foam, COâ‚‚, or dry chemical extinguishers.
- Protective Equipment: Firefighters should wear self-contained breathing apparatus (SCBA).
Special Notes: Prevent contaminated runoff from entering drains or water sources.
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