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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Category: Active Pharmaceutical Ingredients (APIs) Tags: Antiglaucoma Agent, Beta-Blocker API, Pharmaceutical Raw Material, Timolol Maleate, Timolol Maleate BP

Description

Table of Contents

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.

KEY PRODUCT FEATURES

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

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