Description

Timolol Impurity 5 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the ophthalmic β-blocker drug Timolol. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Timolol maleate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurity levels.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure Timolol products meet stringent pharmacopeial specifications (USP, EP, ICH Q3A/B).
• Stability Studies: Used to track the formation of degradation products in Timolol formulations under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Research & Development: Utilized in R&D to study the degradation pathways and chemical behavior of Timolol.

Basic Information

Product Name	Timolol Impurity 5
CAS No.	75045-22-6
Molecular Formula	C13H24N4O3S
Molecular Weight	316.42 g/mol
Synonyms	Timolol Related Compound 5; Timolol EP Impurity B; Timolol USP Impurity; (S)-3-(3-tert-Butylamino-2-hydroxypropoxy)-4-morpholino-1,2,5-thiadiazole; 1,2,5-Thiadiazole-3-carboxamide, N-(1,1-dimethylethyl)-4-morpholinyl-; Timolol Degradation Product; Timolol Maleate Impurity 5
EINECS	Contact for details

Quality Control

Every batch of Timolol Impurity 5 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis, to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and methods.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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