Description

Phenylephrine Impurity 32 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 utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling.

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 & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurities in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure batch-to-batch consistency and that impurity levels remain within specified regulatory limits.
• Stability Studies: Used to track the formation of degradation products in phenylephrine formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Research & Development: Supports synthetic chemistry research aimed at understanding degradation pathways and improving the synthesis of phenylephrine.

Basic Information

Item	Details
Product Name	Phenylephrine Impurity 32
CAS No.	1312706-19-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Phenylephrine Related Compound 32; Phenylephrine EP Impurity 32; Phenylephrine USP Impurity 32; (1R,2S)-2-(3-Hydroxyphenyl)-1-(methylamino)ethanol impurity 32; Phenylephrine Degradation Product 32; Phenylephrine Process Impurity 32; Phenylephrine Specified Impurity 32
EINECS	Contact for details

Quality Control

Every batch of Phenylephrine Impurity 32 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request, providing detailed results for identity, purity, and impurity content. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 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
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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