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Timolol Maleate BP
Timolol Maleate BP is the British Pharmacopoeia-grade salt form of Timolol, a non-selective beta-adrenergic receptor blocker. It is primarily used in ophthalmic and systemic formulations to manage elevated intraocular pressure and cardiovascular conditions. As a pharmaceutical active ingredient, it is recognized for its potency, stability, and wide applicability in glaucoma treatment, hypertension, and migraine prophylaxis. The maleate salt improves solubility and stability for formulation in eye drops and tablets.
Timolol Maleate BP
Primary Uses
- Pharmaceutical Industry
- Ophthalmic Solutions:
- Glaucoma Treatment: Reduces intraocular pressure by decreasing aqueous humor production in the eye.
- Ocular Hypertension: Used in managing elevated intraocular pressure in patients without glaucoma.
- Chronic Open-Angle Glaucoma: Widely used in first-line and adjunct therapy to prevent optic nerve damage.
- Cardiovascular Medications:
- Hypertension Management: Systemic formulations used to lower blood pressure by reducing cardiac output.
- Arrhythmias: Helps control heart rate in certain cardiac arrhythmias such as atrial fibrillation.
- Angina Pectoris: Reduces myocardial oxygen demand by decreasing heart rate and contractility.
- Post-Myocardial Infarction: Used to improve survival and reduce the risk of further cardiac events.
- Neurological Uses:
- Migraine Prophylaxis: Effective in preventing vascular headaches through beta-blockade of cerebral vessels.
Secondary Uses
- Veterinary Medicine
- Glaucoma in Pets: Used off-label in veterinary ophthalmology to treat glaucoma in dogs and cats.
- Combination Therapies
- Fixed-Dose Combinations: Frequently combined with other agents (e.g., dorzolamide, brimonidine) for enhanced efficacy in ocular hypertension and glaucoma.
- Research & Development
- Pharmacodynamic and Pharmacokinetic Studies: Used in laboratory research on beta-blockers, receptor selectivity, and ophthalmic drug delivery.
1. Basic Identification Attributes
- Chemical Name (IUPAC): (S)-1-[(1,1-dimethylethyl)amino]-3-[(4-morpholinyl)-1,2,5-thiadiazol-3-yl]propan-2-ol maleate
- Common/Trade Name: Timolol Maleate BP
- CAS Number: 26921-17-5
- HS Code: 3004.90.00 (Finished form), or 2933.39.90 (API/intermediate)
- Synonyms: Timolol hydrogen maleate, Timoptic (as brand name), Blocadren (oral form)
2. Physical & Chemical Properties
- Physical State: Crystalline powder
- Color & Odor: White to off-white; odorless
- Melting Point: Approx. 200–205 °C
- Solubility: Freely soluble in water and alcohol
- Molecular Formula: C₁₃H₂₄N₄O₃S·C₄H₄O₄
- Molecular Weight: 432.50 g/mol
- pH (1% solution): Typically around 5.5–7.5
3. Safety & Hazard Attributes
- GHS Classification: Not classified as hazardous under standard pharmaceutical handling
- Toxicity: Low to moderate systemic toxicity; use strictly under medical supervision
- LD50: Approx. 1050 mg/kg (oral, rat)
- Exposure Limits: Handle in accordance with pharmaceutical safety protocols; occupational exposure limits may apply in manufacturing settings
4. Storage & Handling Attributes
- Storage Conditions: Store in a tightly closed container, in a dry and cool place, protected from light
- Container Type: Double-lined fiber drums or HDPE containers for API; sterile bottles for finished products
- Shelf Life: Typically 36 months when stored under recommended conditions
- Handling Precautions: Avoid dust generation; wear protective gear in manufacturing environments
5. Regulatory & Compliance Attributes
- Complies with British Pharmacopoeia (BP) specifications
- Also meets or aligns with USP, EP, and JP standards depending on manufacturer
- Listed on WHO Essential Medicines List (as Timolol eye drops for glaucoma)
- Manufactured under GMP, ICH Q7, and FDA guidelines
- Registered under REACH (if imported into the EU for manufacturing)
- Subject to Controlled Substance Monitoring in some countries due to cardiovascular action
6. Environmental & Health Impact
- Biodegradability: Moderate; pharmaceutical compounds may persist in aquatic environments
- Ecotoxicity: Can affect aquatic organisms at very low concentrations; must be properly disposed
- Bioaccumulation: Not expected to significantly bioaccumulate
- Disposal: Should be incinerated or disposed of per pharmaceutical waste guidelines
Safety Handling Precautions
- PPE Required: Gloves, lab coat, dust mask or respirator in manufacturing areas
- Handling Guidelines: Avoid inhalation and direct contact with skin or eyes
- Storage Measures: Store under controlled conditions; segregate from incompatible substances
First Aid Measures
- Inhalation: Move to fresh air; seek medical attention if symptoms occur
- Skin Contact: Wash with plenty of soap and water
- Eye Contact: Rinse thoroughly with water; consult a physician if irritation persists
- Ingestion: Do not induce vomiting; seek immediate medical attention
Firefighting Measures
- Fire Hazards: Not highly flammable; may burn at high temperatures
- Extinguishing Media: Water spray, foam, CO₂, dry chemical
- Hazardous Combustion Products: Carbon oxides, nitrogen oxides, and sulfur compounds
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