Description

Propranolol Impurity CAS NO 77252-87-0 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Propranolol. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, impurity profiling, and quality control testing. The availability of a well-characterized impurity standard is essential for maintaining the stringent purity standards demanded in modern pharmaceutical production.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity during the manufacturing and stability testing of Propranolol API.
• Analytical Method Development and Validation: Serves as a critical standard for developing, validating, and verifying HPLC, UPLC, and GC analytical methods to ensure accuracy and specificity in impurity detection.
• Quality Control and Assurance (QC/QA): Employed in routine quality control laboratories to confirm the impurity levels in Propranolol batches comply with pharmacopeial limits (e.g., USP, EP, ICH guidelines).
• Regulatory Compliance and Submissions: Essential for generating data required for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough understanding and control of the drug substance impurity profile.
• Stability Studies: Used to assess the formation of degradation products in Propranolol formulations under various stress conditions (heat, light, humidity) as per ICH Q1A(R2) guidelines.
• Research and Development: Utilized in pharmaceutical R&D for studying the metabolic pathways, synthesis pathways, and degradation mechanisms of Propranolol.

Basic Information

Product Name	Propranolol Impurity
CAS No.	77252-87-0
Molecular Formula	C16H21NO2
Molecular Weight	259.34 g/mol
Synonyms	1-(Isopropylamino)-3-(naphthalen-1-yloxy)propan-2-ol; 1-Naphthol, 1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-2-propanol; Propranolol Related Compound; Propranolol EP Impurity; Propranolol USP Impurity; Naphthyloxypropranolol; 1-(1-Naphthyloxy)-2-hydroxy-3-isopropylaminopropane
EINECS	Contact for details

Quality Control

Every batch of Propranolol Impurity CAS 77252-87-0 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B guidelines and can supply materials suitable for use in regulated environments.

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 must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an 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 individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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