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.

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Category: Active Pharmaceutical Ingredients (APIs) Tags: Anti-inflammatory treatment, Betamethasone sodium phosphate, Injectable formulations, Pharmaceutical ingredient, Topical corticosteroid, White to off-white powder

Description

Primary Uses

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, CO₂, 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.