Description

Phenylephrine Impurity CAS NO 2292095-11-3 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development. This compound is critical for ensuring the safety and efficacy of phenylephrine-based drug products by enabling the accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, method validation, and compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in phenylephrine 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, to meet ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control and Stability Studies: Employed in routine QC testing and forced degradation studies to monitor impurity levels and ensure product stability and shelf-life.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control and adherence to pharmacopeial standards (USP, EP).
• Research and Development: Supports synthetic route optimization and process chemistry research by helping to understand and control the formation of process-related impurities.

Basic Information

Item	Detail
Product Name	Phenylephrine Impurity
CAS No.	2292095-11-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Phenylephrine Related Compound; Phenylephrine Impurity Standard; Phenylephrine Process Impurity; (1R,2S)-2-(methylamino)-1-(3-hydroxyphenyl)ethanol impurity; Phenylephrine HCl Impurity; Norphenylephrine derivative; Adrenergic impurity reference
EINECS	Contact for details

Quality Control

Every batch of Phenylephrine Impurity CAS NO 2292095-11-3 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 industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and other critical parameters.

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 must be kept in a dry environment and sealed immediately after use to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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