Description

Timolol Impurity I CAS NO 2469037-77-0 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 Timolol, a widely used β-blocker medication. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality control. The impurity standard supports method validation, stability studies, and impurity profiling to meet stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Timolol maleate and related drug substances and products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used to develop, calibrate, and validate chromatographic methods for accurate impurity detection and quantification.
• Stability and Forced Degradation Studies: Employed to identify and monitor this specific degradation product in Timolol formulations under various stress conditions.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Pharmacopeial Testing: Supports testing to comply with monographs from USP (United States Pharmacopeia), EP (European Pharmacopoeia), and other international pharmacopeias.
• Research & Development: Used in R&D laboratories to study the synthesis pathways, degradation mechanisms, and toxicological profiles of Timolol-related impurities.

Basic Information

Product Name	Timolol Impurity I
CAS No.	2469037-77-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Timolol Related Compound I; Timolol EP Impurity I; Timolol USP Impurity I; Timolol Degradation Product; (S)-1-[(1,1-Dimethylethyl)amino]-3-[[4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl]oxy]-2-propanol Impurity; 4-Morpholinecarboxamide, N-[3-[[(1,1-dimethylethyl)amino]-2-hydroxypropoxy]-1,2,5-thiadiazol-4-yl]-; UNII-Contact for details
EINECS	Contact for details

Quality Control

Every batch of Timolol Impurity I is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC and LC-MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP, ICH Q3A/B guidelines, and relevant regulatory frameworks (FDA, EMA).

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 must be kept under inert conditions or in a desiccator to maintain stability and purity. Keep the container tightly sealed when not in use.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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