Description

Timolol Impurity 1 is a specified impurity of the β-blocker drug Timolol, used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of Timolol-based drug products through rigorous analytical method development and validation. It is an essential reference standard for pharmaceutical manufacturers, quality control laboratories, and regulatory affairs professionals involved in the production and approval of cardiovascular and ophthalmic medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Timolol Impurity 1 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, or GC methods to monitor impurities in Timolol maleate during stability studies and batch release testing.
• Quality Control & Assurance: Used in-house by QC laboratories to establish acceptance criteria and ensure batches comply with pharmacopeial standards (USP, EP, ICH Q3A/B).
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing impurity profiles and qualification data as per ICH guidelines.
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions (heat, light, humidity).
• Process Chemistry & Optimization: Aids chemists in identifying and minimizing the formation of this impurity during the synthesis and purification of Timolol.

Basic Information

Product Name	Timolol Impurity 1
CAS No.	75014-25-4
Molecular Formula	C13H24N4O3S
Molecular Weight	316.42 g/mol
Synonyms	Timolol Related Compound A; Timolol EP Impurity A; Timolol USP Impurity; 1-(tert-Butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol; (S)-Timolol Impurity 1; 3-Morpholino-4-[[(1,1-dimethylethyl)amino]methyl]oxy-1,2,5-thiadiazole; Timolol Degradation Product
EINECS	Contact for details

Quality Control

Every batch of Timolol Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic techniques (HPLC, GC) and spectroscopic methods (NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is 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). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Assay (HPLC)	97.0% - 103.0% (on anhydrous basis)

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