Description

Timolol Impurity 2 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of Timolol, a widely used β-blocker medication. It is an essential tool for pharmaceutical manufacturers and analytical laboratories engaged in method development, validation, and regulatory compliance. The precise characterization of this impurity is fundamental to maintaining the highest standards in drug substance and finished product quality.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Timolol Impurity 2 in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling of Timolol.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing to ensure impurity levels are within International Council for Harmonisation (ICH) guidelines.
• Regulatory Compliance & Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH stability guidelines.
• Research & Development (R&D): Used in synthetic chemistry research to study the formation pathways and chemical behavior of this impurity.

Basic Information

Product Name	Timolol Impurity 2
CAS No.	75014-26-5
Molecular Formula	C13H24N4O3S
Molecular Weight	316.42 g/mol
Synonyms	Timolol Related Compound B; (S)-1-(tert-Butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol; Timolol EP Impurity B; Timolol USP Related Compound B; 3-[(4-Morpholinyl)-1,2,5-thiadiazol-3-yl]oxy-1-[(1,1-dimethylethyl)amino]-2-propanol; (S)-Timolol Impurity 2; Timolol Impurity B; L-714,465 (base)
EINECS	Contact for details

Quality Control

Every batch of Timolol Impurity 2 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques including HPLC, GC, MS, and NMR to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality systems are designed to support compliance with cGMP, ICH Q3A/B, and relevant pharmacopoeial guidelines (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive); ensure the container is kept in a dry environment. For long-term storage, consider storing under an inert atmosphere to prevent potential oxidation.

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)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 0.5% w/w
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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