Description

Phenylephrine Impurity 51 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 required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for maintaining stringent quality control in drug substance and drug product manufacturing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Phenylephrine Hydrochloride API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods in quality control laboratories.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., ANDA, NDA) by providing necessary impurity data to agencies like the US FDA, EMA, and PMDA.
• Stability Studies: Employed to monitor the formation of this specific degradant during forced degradation and long-term stability testing of phenylephrine products.
• Pharmacopoeial Testing: Used to verify compliance with monographs in USP, EP, BP, or other international pharmacopoeias.
• Research & Development: Serves as a key intermediate or degradant marker in synthetic chemistry and degradation pathway studies.

Basic Information

Product Name	Phenylephrine Impurity 51
CAS No.	1007885-60-0
Molecular Formula	C9H13NO2
Molecular Weight	167.21 g/mol
Synonyms	1-(3-Hydroxyphenyl)-2-(methylamino)ethanol impurity 51; Phenylephrine Related Compound 51; (R)-1-(3-Hydroxyphenyl)-2-(methylamino)ethanol impurity; Phenylephrine EP Impurity I; Phenylephrine USP Impurity; Phenylephrine Degradant; 3-Hydroxy-α-[(methylamino)methyl]benzenemethanol impurity
EINECS	Contact for details

Quality Control

Every batch of Phenylephrine Impurity 51 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards. Comprehensive characterization is performed using advanced techniques including HPLC, GC-MS, NMR, and IR spectroscopy. Certificates of Analysis (COA) are available upon request, providing detailed batch-specific data on purity, identity, and impurity 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 compound is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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