Description

Timolol Ep Impurity H is a specified impurity and degradation product of the β-blocker drug Timolol, used in analytical and pharmaceutical development. This compound is critical for ensuring the quality, safety, and efficacy of Timolol-based pharmaceutical products by serving as a reference standard for impurity identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in quality control, method validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Timolol impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to ensure the accuracy and precision of impurity assays.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability profiling.
• Regulatory Submissions: Provides necessary data on impurity characterization for regulatory filings with agencies like the FDA, EMA, and other global health authorities.
• Research & Development: Used in R&D to study the degradation pathways and chemical behavior of Timolol, aiding in the formulation of more stable drug products.

Basic Information

Product Name	Timolol Ep Impurity H
CAS No.	158636-97-6
Molecular Formula	C13H24N4O3S
Molecular Weight	316.42 g/mol
Synonyms	Timolol Impurity H; Timolol Related Compound H; Timolol Degradation Product H; (S)-1-[(1,1-Dimethylethyl)amino]-3-[[4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl]oxy]-2-propanol Impurity; 3-[(2-{[(1,1-Dimethylethyl)amino]methyl}-4-morpholinyl)methyl]-4-(4-morpholinyl)-1,2,5-thiadiazole; Timolol EP Impurity H
EINECS	Contact for details

Quality Control

Every batch of Timolol Ep Impurity H is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including relevant pharmacopoeial guidelines (e.g., EP, USP). Comprehensive characterization is performed using advanced analytical techniques. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request.

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) and should be handled under anhydrous conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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