Description

Phenylephrine Usp Rc G CAS NO 1094089-46-9 is a high-purity pharmaceutical-grade reference standard, specifically the G grade as per the United States Pharmacopeia (USP). This compound is critical for ensuring the accuracy, quality, and regulatory compliance of analytical methods in pharmaceutical development and quality control. It is an essential material for research laboratories, analytical service providers, and manufacturers requiring precise calibration and validation of assays for phenylephrine-based drug products.

Application

• Pharmaceutical Reference Standard: Primary use as a USP-grade certified reference material (CRM) for system suitability testing, method validation, and assay calibration in HPLC, GC, and other chromatographic analyses.
• Quality Control & Assurance: Used by QC laboratories in pharmaceutical manufacturing to verify the identity, potency, and purity of active pharmaceutical ingredients (APIs) and finished drug products containing phenylephrine.
• Pharmacopeial Testing: Essential for conducting tests and assays as mandated by USP, EP, BP, and other international pharmacopeias to ensure drug compliance.
• Analytical Method Development: Serves as a benchmark compound for developing, optimizing, and transferring new analytical methods in research and development settings.
• Regulatory Submissions: Provides the necessary traceable standard for generating data included in regulatory filings (e.g., ANDA, NDA) with agencies like the FDA, EMA, and PMDA.
• Forensic and Clinical Analysis: Used as a standard in forensic toxicology and clinical research to accurately quantify phenylephrine levels in biological matrices.

Basic Information

Product Name	Phenylephrine Usp Rc G
CAS No.	1094089-46-9
Molecular Formula	C9H13NO2
Molecular Weight	167.21 g/mol
Synonyms	(R)-(-)-Phenylephrine; L-Phenylephrine; (-)-Phenylephrine; (R)-(-)-1-(3-Hydroxyphenyl)-2-methylaminoethanol; meta-Hydroxy-α-[(methylamino)methyl]benzyl alcohol; L-(-)-m-Hydroxy-α-[(methylamino)methyl]benzyl alcohol; USP Phenylephrine Related Compound G; Phenylephrine Impurity G; Phenylephrine EP Impurity G
EINECS	Contact for details

Quality Control

This USP Reference Standard (G Grade) is manufactured and certified under strict quality systems to meet the exacting requirements of pharmacopeial standards. Each batch is accompanied by a comprehensive Certificate of Analysis (COA) that provides traceability to primary standards and documents critical parameters including identity, purity, and chromatographic profile. Our quality assurance protocols ensure compliance with relevant guidelines for reference standard materials.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Meets USP requirements
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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