Description

(S)-Isotimolol (Timolol Impurity B) is a high-purity chiral impurity standard critical for pharmaceutical research and quality control. This compound is essential for the accurate identification, quantification, and control of stereochemical impurities in Timolol maleate, a widely used β-blocker medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug safety, efficacy, and compliance with stringent pharmacopeial standards such as USP and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the calibration of analytical instruments in method development and validation.
• Impurity Profiling & Control: Critical for identifying and quantifying the (S)-enantiomer impurity in Timolol maleate active pharmaceutical ingredient (API) batches to meet ICH Q3A/B guidelines.
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies of Timolol formulations to monitor impurity formation.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability standard in HPLC and LC-MS methods to ensure the accuracy and precision of impurity testing protocols.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Chiral Separation Research: Used in the development and optimization of chiral chromatography methods for β-blocker analysis.

Basic Information

Product Name	(S)-Isotimolol (Timolol Impurity B)
CAS No.	158636-96-5
Molecular Formula	C13H24N4O3S
Molecular Weight	316.42 g/mol
Synonyms	(S)-1-(tert-Butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol; (S)-Timolol Impurity B; (S)-Isotimolol; L-Isotimolol; Timolol EP Impurity B; Timolol Related Compound B; (S)-3-[4-(4-Morpholinyl)-1,2,5-thiadiazol-3-yl]oxy-1-(1,1-dimethylethyl)amino-2-propanol
EINECS	Contact for details

Quality Control

Every batch of (S)-Isotimolol is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including chiral purity and related substance data, is provided with each shipment to support your regulatory and research needs.

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 must be kept in a desiccated environment to maintain stability and purity. Avoid prolonged exposure to air during handling.

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%
Chiral Purity (Chiral HPLC)	≥ 99.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
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.