Description

Timolol Hemihydrate is a potent, non-selective β-adrenergic receptor blocking agent, widely recognized for its therapeutic efficacy. This high-purity active pharmaceutical ingredient (API) is critical for ensuring the safety and consistency of finished pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers and research institutions for the development and production of ophthalmic solutions and oral medications targeting cardiovascular and ocular conditions.

Application

• Ophthalmic Solutions: Primary active ingredient in eye drops for the management of elevated intraocular pressure in conditions like glaucoma and ocular hypertension.
• Oral Pharmaceutical Formulations: Used in tablet or capsule form for the treatment of systemic hypertension (high blood pressure) and angina pectoris.
• Cardiovascular Research: Serves as a key reference standard and tool compound in pharmacological studies investigating β-blocker mechanisms and cardiovascular physiology.
• API Synthesis: Employed as a critical intermediate or final compound in the synthesis and scale-up of β-blocker drug products under Good Manufacturing Practice (GMP) conditions.
• Analytical Standard: Used as a certified reference material (CRM) in quality control laboratories for HPLC, UV, and other analytical method development and validation.

Basic Information

Product Name	Timolol Hemihydrate
CAS No.	91524-16-2
Molecular Formula	C13H24N4O3S · ½H2O
Molecular Weight	316.41 g/mol (anhydrous basis)
Synonyms	Timolol Hemihydrate; (S)-Timolol Hemihydrate; (-)-Timolol Hemihydrate; Timolol Maleate Related Compound A (Hemihydrate); (S)-1-(tert-Butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol Hemihydrate; Blocadren (base); Timoptic (base); MK-950
EINECS	Contact for details

Quality Control

Our Timolol Hemihydrate is manufactured and tested to meet stringent pharmacopeial standards, including USP and EP monographs where applicable. Every batch undergoes comprehensive analytical testing to ensure identity, potency, purity, and the control of specified impurities. A Certificate of Analysis (COA) detailing all test results is provided with each shipment to guarantee traceability and compliance with your quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	2.0% - 3.5% (theoretical for hemihydrate: ~2.8%)
Related Substances (HPLC)	Individual impurity: ≤0.5%; Total impurities: ≤2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Specific Rotation	-11.5° to -13.5° (c = 5 in water)
Heavy Metals	≤20 ppm
Sulfated Ash	≤0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.