Description

Phenylephrine Impurity 12 is a designated reference standard used in the analytical profiling and quality control of Phenylephrine, a widely used pharmaceutical agent. This compound is critical for ensuring the purity, safety, and efficacy of Phenylephrine-based drug products by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Phenylephrine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development: Essential for developing and validating High-Performance Liquid Chromatography (HPLC) and Ultra-High-Performance Liquid Chromatography (UPLC) methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing necessary impurity data for drug approval processes.
• Stability Studies: Employed to monitor the formation of degradation products in Phenylephrine formulations under various stress conditions over time.
• Pharmacopoeial Testing: Used to comply with testing requirements specified in pharmacopoeias such as USP (United States Pharmacopeia) and EP (European Pharmacopoeia).
• Research & Development: Facilitates impurity characterization and route scouting during the synthetic process development of Phenylephrine.

Basic Information

Product Name	Phenylephrine Impurity 12
CAS No.	2575516-52-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Phenylephrine Related Compound 12; Phenylephrine EP Impurity J; Phenylephrine USP Impurity; (1R,2S)-2-Methylamino-1-(3-hydroxyphenyl)ethanol impurity; Phenylephrine Process Impurity; Norphenylephrine derivative; Decongestant Impurity Standard
EINECS	Contact for details

Quality Control

Every batch of Phenylephrine Impurity 12 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards for reference materials. Comprehensive characterization is performed using advanced techniques including HPLC, GC-MS, and NMR. Certificates of Analysis (COA) are available upon request, providing detailed information on purity, identity, and chromatographic profile.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines
Water Content (KF)	≤ 5.0%

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