Description

Phenylephrine Ep Impurity D is a critical pharmaceutical reference standard used for analytical and quality control purposes. This compound is essential for ensuring the purity, safety, and efficacy of Phenylephrine Active Pharmaceutical Ingredients (APIs) and finished drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specified impurities in Phenylephrine HCl and related drug substances.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and other chromatographic methods in QC laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Phenylephrine formulations under various stress conditions.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for submission to agencies like the US FDA and EMA.
• Pharmacopoeial Testing: Used for compliance testing against monographs in USP (United States Pharmacopeia), EP (European Pharmacopoeia), and other international pharmacopoeias.
• In-House Quality Control: Acts as a primary standard for routine batch release testing of Phenylephrine API to ensure it meets stringent purity specifications.

Basic Information

Product Name	Phenylephrine Ep Impurity D
CAS No.	1367567-95-0
Molecular Formula	C9H13NO2
Molecular Weight	167.21 g/mol
Synonyms	Phenylephrine Related Compound D; (R)-1-(3-Hydroxyphenyl)-2-(methylamino)ethanol; Phenylephrine Impurity D; 1-(3-Hydroxyphenyl)-2-(methylamino)ethanol (Impurity of Phenylephrine); Phenylephrine EP Impurity D; Phenylephrine USP Impurity D; m-Hydroxy-α-[(methylamino)methyl]benzyl alcohol (impurity); Phenylephrine Specified Impurity D
EINECS	Contact for details

Quality Control

Every batch of Phenylephrine Ep Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with pharmacopoeial standards (USP/EP) and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC, NMR, and MS analyses.

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 hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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