Description

Phenylephrine Impurity 24 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing phenylephrine. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, impurity profiling, and stability studies. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in drug development and production.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific impurities in Phenylephrine Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Used as a critical component in developing and validating sensitive HPLC, UPLC, or GC methods for impurity detection.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Quality Control and Batch Release Testing: Acts as a system suitability standard and a quantitative marker in the routine QC testing of Phenylephrine to ensure batch-to-batch consistency and compliance with pharmacopeial limits (e.g., USP, EP).
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the impurity profile.
• Research and Development: Used in metabolic studies, pharmacokinetic research, and to understand the chemical pathways of impurity formation.

Basic Information

Product Name	Phenylephrine Impurity 24
CAS No.	2353261-33-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Phenylephrine Related Compound 24; Phenylephrine EP Impurity 24; Phenylephrine USP Impurity 24; (1R,2S)-2-Methylamino-1-(3-hydroxyphenyl)ethanol impurity 24; Phenylephrine Degradation Product 24; Phenylephrine Process Impurity 24; Desmethyl Phenylephrine Analog
EINECS	Contact for details

Quality Control

Every batch of Phenylephrine Impurity 24 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening using advanced techniques like HPLC, GC-MS, and NMR to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents. We support compliance with ICH Q3A/B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle the material under an inert atmosphere if specified to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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