Description

Phenoxybenzamine Impurity 5 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 Phenoxybenzamine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling in accordance with ICH guidelines.

Application

• Pharmaceutical Impurity Reference Standard for quality control and release testing of Phenoxybenzamine API.
• Analytical Method Development and Validation (HPLC, GC, LC-MS) in R&D and QC laboratories.
• Stability Studies and degradation pathway elucidation for pharmaceutical formulations.
• Pharmacological and Toxicological Research to study metabolite profiles and safety.
• Regulatory Documentation and Submission to agencies like the FDA and EMA.
• Calibration and Qualification of analytical instruments and systems.

Basic Information

Item	Detail
Product Name	Phenoxybenzamine Impurity 5
CAS No.	57619-17-7
Molecular Formula	C17H21Cl2NO
Molecular Weight	326.26 g/mol
Synonyms	N-(2-Chloroethyl)-N-(1-methyl-2-phenoxyethyl)benzylamine; N-Benzyl-N-(2-chloroethyl)-1-methyl-2-phenoxyethylamine; Phenoxybenzamine Related Compound; Phenoxybenzamine EP Impurity; Phenoxybenzamine USP Impurity; Dibenzyline Impurity; 1-(Benzyl(2-chloroethyl)amino)-3-phenoxy-2-methylpropane
EINECS	Contact for details

Quality Control

Our Phenoxybenzamine Impurity 5 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity, identity confirmation, and residual solvent analysis, to ensure it meets the stringent requirements for a pharmaceutical reference standard. A Certificate of Analysis (COA) detailing all test results is provided with every shipment.

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 should be handled in a dry environment to prevent degradation.

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%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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