Description

Propranolol Impurity 6 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 β-blocker drug Propranolol. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality control. The material is supplied with comprehensive analytical data to support method validation and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Propranolol-related impurities in active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods (e.g., HPLC, UPLC, GC) in quality control laboratories.
• Stability Studies & Forced Degradation: Employed to monitor and characterize degradation products formed during drug stability testing under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for submission to agencies like the FDA, EMA, and PMDA.
• Pharmacopoeial Testing: Used to verify compliance with purity specifications outlined in pharmacopoeias such as USP, EP, BP, and JP.
• Research & Development: Serves as a key intermediate or marker in synthetic chemistry research and the study of Propranolol's metabolic pathways.

Basic Information

Product Name	Propranolol Impurity 6
CAS No.	27827-19-6
Molecular Formula	C16H21NO2
Molecular Weight	259.35 g/mol
Synonyms	1-(Isopropylamino)-3-(naphthalen-1-yloxy)propan-2-ol; 1-[(1-Methylethyl)amino]-3-(1-naphthalenyloxy)-2-propanol; N-Isopropyl-1-naphthoxy-2-hydroxy-3-propylamine; Propranolol Related Compound; Propranolol EP Impurity; Propranolol USP Impurity
EINECS	Contact for details

Quality Control

Every batch of Propranolol Impurity 6 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and traceability meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory 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). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

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)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.