Description

Penbutolol Impurity A is a designated impurity of the β-blocker pharmaceutical, Penbutolol. This compound is critical for analytical reference and quality control processes in pharmaceutical development and manufacturing. It is primarily used by research institutions, quality assurance laboratories, and API producers to ensure the purity, safety, and efficacy of the final drug product.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Penbutolol Impurity A in drug substances and products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity specifications and justify safety thresholds.
• Process Chemistry Research: Used to study and optimize synthetic pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Penbutolol Impurity A
CAS No.	112160-87-9
Molecular Formula	C18H31NO3
Molecular Weight	309.45 g/mol
Synonyms	1-(tert-Butylamino)-3-(2-cyclopentylphenoxy)propan-2-ol; (RS)-1-(tert-Butylamino)-3-(o-cyclopentylphenoxy)-2-propanol; Penbutolol Related Compound A; Penbutolol EP Impurity A; Penbutolol USP Impurity A; Penbutolol Process Impurity; o-Cyclopentylphenoxy analogue of Penbutolol
EINECS	Contact for details

Quality Control

Every batch of Penbutolol Impurity A is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with pharmacopeial standards (USP/EP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing all test results, including HPLC purity, is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure maximum stability.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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