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Timolol Maleate BP

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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.

 

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Description

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.

 

 

PRODUCT KEY FEATURES

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)

 

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

 

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

 

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

 

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

 

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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