Description

Phenylephrine Impurity 33 is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the safety and efficacy of pharmaceutical products containing phenylephrine by enabling accurate identification and quantification of this specific impurity. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies focused on method development, validation, and compliance testing.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material to identify and quantify Phenylephrine Impurity 33 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or GC methods in quality control laboratories.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Compliance and Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate control over potential impurities as per ICH Q3A and Q3B guidelines.
• Quality Control and Batch Release Testing: Acts as a primary standard in routine QC testing to ensure impurity levels in commercial batches of phenylephrine are within specified limits.
• Research and Development: Utilized in R&D to study the degradation pathways of phenylephrine and to synthesize purer API forms.

Basic Information

Product Name	Phenylephrine Impurity 33
CAS No.	1312706-18-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Phenylephrine Related Compound 33; Phenylephrine EP Impurity 33; Phenylephrine USP Impurity 33; (1R,2S)-2-Methylamino-1-(3-hydroxyphenyl)ethanol impurity 33; Phenylephrine Degradation Product; Phenylephrine Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Phenylephrine Impurity 33 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

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 unknown 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.