Description

Timolol Ep Impurity G is a specified impurity of the β-blocker drug Timolol, used in pharmaceutical research and development. This compound is critical for analytical method development, stability studies, and ensuring the quality and safety of the final active pharmaceutical ingredient (API). It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for quality control and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Timolol-related impurities in drug substances and products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Stability Indicating Studies: Employed in forced degradation studies to understand the degradation pathways of Timolol and to establish stability-indicating methods.
• Quality Control & Batch Release: Essential for routine quality control testing to ensure Timolol API and finished drug products meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Research on Degradation Chemistry: Aids in studying the formation mechanisms and chemical behavior of this specific impurity under various conditions.

Basic Information

Product Name	Timolol Ep Impurity G
CAS No.	75202-36-7
Molecular Formula	C13H24N4O3S
Molecular Weight	316.42 g/mol
Synonyms	Timolol Impurity G; Timolol EP Impurity G; (S)-1-(tert-Butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]propan-2-ol; (S)-3-[4-(4-Morpholinyl)-1,2,5-thiadiazol-3-yl]oxy-1-(1,1-dimethylethyl)amino-2-propanol; Timolol Related Compound G; Timolol Impurity 7; Timolol EP Impurity 7
EINECS	Contact for details

Quality Control

Our Timolol Ep Impurity G is manufactured and tested under strict quality management systems. Each batch undergoes comprehensive analytical characterization to ensure identity, purity, and traceability, meeting the requirements for use as a reference standard. A detailed Certificate of Analysis (COA) is provided, which includes data from HPLC purity assay, related substance analysis, and structural confirmation (e.g., by NMR and MS).

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 in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.