Description

Propranolol Ep Impurity B Hcl (Mixture Of Diastereomers) is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the analysis and quality control of Propranolol Hydrochloride, a widely used β-blocker medication. It is an essential material for analytical chemists and quality assurance professionals working to ensure drug safety, efficacy, and regulatory compliance. The product is supplied with a Certificate of Analysis to guarantee its identity and purity for its intended use.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify this specific diastereomeric impurity in Propranolol Hydrochloride active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, for impurity detection.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine batch testing within pharmaceutical QC laboratories to monitor impurity levels against International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Used to track the formation of this impurity over time under various stress conditions, supporting drug shelf-life determination.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Facilitates chemical and metabolic studies related to Propranolol, aiding in the understanding of its degradation pathways.

Basic Information

Product Name	Propranolol Ep Impurity B Hcl (Mixture Of Diastereomers)
CAS No.	2172495-51-9
Molecular Formula	C16H22ClNO2 • HCl
Molecular Weight	332.27 g/mol (for free base: 295.80)
Synonyms	1-(Isopropylamino)-3-(naphthalen-1-yloxy)propan-2-ol Ep Impurity B Hydrochloride; Propranolol Related Compound B HCl; Propranolol EP Impurity B (Diastereomer Mixture) Hydrochloride; 1-[(1-Methylethyl)amino]-3-(1-naphthalenyloxy)-2-propanol Ep Impurity B Hydrochloride; Propranolol Diastereomeric Impurity B HCl; (RS)-1-(Isopropylamino)-3-(1-naphthyloxy)propan-2-ol Impurity B Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of Propranolol Ep Impurity B Hcl (Mixture Of Diastereomers) is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing to ensure identity, purity, and consistency, aligning with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including identification, assay, and related substances analysis by HPLC. We support compliance with ICH Q3A, Q3B, and relevant EP/USP guidelines for impurities in new drug substances and products.

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); ensure the container is kept tightly sealed in a dry environment to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0% (Sum of diastereomers)
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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