Description

Phenylephrine Ep Impurity D is a critical reference standard and impurity used in the pharmaceutical development and quality control of Phenylephrine, a widely used α-1 adrenergic receptor agonist. This compound is essential for ensuring the safety, efficacy, and regulatory compliance of Phenylephrine-based drug products by enabling accurate identification, quantification, and control of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, method validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the qualitative and quantitative analysis of Phenylephrine Ep Impurity D in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Used to develop, optimize, and validate analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and Ultra-Performance Liquid Chromatography (UPLC), for impurity profiling.
• Quality Control and Batch Release: A critical component in the quality control (QC) testing of Phenylephrine to monitor and control impurity levels, ensuring compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed as a marker to track the formation of degradation products during forced degradation and long-term stability studies of Phenylephrine formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, MAA) to demonstrate thorough impurity characterization and control strategies to agencies like the FDA and EMA.
• Research and Development: Used in synthetic chemistry R&D to understand impurity formation pathways and to develop robust purification processes for Phenylephrine API.

Basic Information

Product Name	Phenylephrine Ep Impurity D
CAS No.	286426-31-1
Molecular Formula	C9H13NO2
Molecular Weight	167.21 g/mol
Synonyms	1-(3-Hydroxyphenyl)-2-(methylamino)ethanol; Phenylephrine Related Compound D; (R)-1-(3-Hydroxyphenyl)-2-methylaminoethanol; Phenylephrine Impurity D; Phenylephrine EP Impurity D; Phenylephrine USP Impurity D; m-Hydroxy-α-[(methylamino)methyl]benzyl alcohol; Norphenylephrine
EINECS	Contact for details

Quality Control

Every batch of Phenylephrine Ep Impurity D is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and assay testing using validated analytical methods, including HPLC, NMR, and Mass Spectrometry, to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to prevent potential oxidation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w
Assay (HPLC)	97.0% - 103.0% (on anhydrous basis)

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