Description

Phenylephrine Impurity 30 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 pharmaceutical products containing phenylephrine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The CAS number for this material is 2724689-62-5.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Phenylephrine Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurities during manufacturing.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure drug substances and products meet stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to track the formation of degradation products in phenylephrine formulations under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports metabolic studies, pharmacokinetic research, and the synthesis of related compounds in pharmaceutical R&D.

Basic Information

Product Name	Phenylephrine Impurity 30
CAS No.	2724689-62-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Phenylephrine Related Compound 30; Phenylephrine EP Impurity 30; Phenylephrine USP Impurity 30; (1R,2S)-2-Methylamino-1-(3-hydroxyphenyl)ethanol impurity 30; Phenylephrine Process Impurity; Phenylephrine Degradant; Phenylephrine Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Phenylephrine Impurity 30 is manufactured and controlled under a strict quality management system. Our products undergo rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results against validated specifications. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated place. Handle and store in accordance with good laboratory practices.

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%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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