Description

Phenylephrine Glucuronide is a crucial metabolite and reference standard of the common decongestant phenylephrine. This high-purity compound is essential for pharmaceutical research, development, and quality control, enabling precise metabolic profiling and analytical method validation. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in drug metabolism and pharmacokinetics (DMPK) studies, bioanalytical testing, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for the quantitative and qualitative analysis of phenylephrine and its metabolites in biological matrices.
• Drug Metabolism Studies (DMPK): Critical for investigating the glucuronidation pathway, metabolic stability, and clearance mechanisms of phenylephrine.
• Bioanalytical Method Development & Validation: Serves as a key analyte for developing and validating LC-MS/MS, HPLC, and other chromatographic assays in pharmacokinetic studies.
• Impurity Profiling and Characterization: Employed to identify and quantify related substances and degradation products in active pharmaceutical ingredient (API) and finished product quality control.
• Clinical and Pre-clinical Research: Facilitates accurate measurement of phenylephrine exposure in plasma and urine samples during clinical trials and toxicology assessments.
• Regulatory Submissions: Provides essential data to support Investigational New Drug (IND) and New Drug Application (NDA) filings with agencies like the FDA and EMA.

Basic Information

Product Name	Phenylephrine Glucuronide
CAS No.	2021255-73-0
Molecular Formula	C16H23NO8
Molecular Weight	357.36 g/mol
Synonyms	(1R,2S)-1-(3-Hydroxyphenyl)-2-(methylamino)ethanol 3-O-β-D-Glucuronide; Phenylephrine 3-O-β-D-Glucuronide; Phenylephrine Glucuronide Metabolite; m-Hydroxy-α-[(methylamino)methyl]benzyl alcohol glucuronide; PHE-Gluc; Phenylephrine D6 Glucuronide (related stable isotope); Phenylephrine β-D-Glucuronide
EINECS	Contact for details

Quality Control

Our Phenylephrine Glucuronide is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. A detailed Certificate of Analysis (COA) is provided, confirming compliance with in-house specifications tailored for research and analytical use. We support compliance with cGMP and ICH Q7 guidelines for active pharmaceutical ingredients (APIs) and reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as specified on the label or COA. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (MS)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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