Description

Timolol Impurity E 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. The precise characterization of this impurity is essential for maintaining the highest standards in pharmaceutical production and quality control.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Timolol Impurity E in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods for impurity detection in Timolol maleate and related formulations.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to monitor batch-to-batch consistency and impurity levels against ICH guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific degradation product under various stress conditions.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the degradation pathways and safety profile of Timolol.

Basic Information

Product Name	Timolol Impurity E
CAS No.	1026075-53-5
Molecular Formula	C13H24N4O3S
Molecular Weight	316.42 g/mol
Synonyms	Timolol EP Impurity E; Timolol Related Compound E; 5-[3-(tert-Butylamino)-2-hydroxypropoxy]-3,4-dihydro-2H-thieno[3,2-e][1,2]thiazine-6-sulfonamide 1,1-dioxide; Timolol Sulfone Impurity; Timolol Degradation Product; Timolol Maleate Impurity E; (S)-Timolol Sulfone
EINECS	Contact for details

Quality Control

Every batch of Timolol Impurity E is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters. We are committed to supplying reference materials that meet the exacting requirements of pharmaceutical analysis and regulatory compliance.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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