Description

Oxymetazoline Hydrochloride Ep Impurity A is a high-purity reference standard critical for analytical and regulatory purposes in the pharmaceutical industry. This compound is specifically used for the identification, qualification, and quantification of related substances in Oxymetazoline Hydrochloride drug substances and finished products. It is an essential tool for quality control laboratories, research institutions, and manufacturers engaged in the development and production of nasal decongestant medications to ensure product safety, efficacy, and compliance with stringent pharmacopoeial standards such as the European Pharmacopoeia (EP).

Application

• Pharmaceutical Reference Standard: Primary application as a certified reference material (CRM) for system suitability, method validation, and impurity profiling in accordance with EP, USP, and ICH guidelines.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to establish retention times, calibration curves, and detection limits for impurity A.
• Quality Control & Assurance: Critical for routine batch testing of Oxymetazoline Hydrochloride Active Pharmaceutical Ingredients (APIs) and finished dosage forms to monitor and control impurity levels.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., CMC sections of ANDA, NDA) by providing definitive characterization and specification data for this specified impurity.
• Stability Studies: Employed to track the formation and increase of this impurity over time under various stress conditions, supporting shelf-life determination.
• Research & Development: Used in synthetic chemistry R&D to understand degradation pathways and optimize manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Oxymetazoline Hydrochloride Ep Impurity A
CAS No.	1391194-44-7
Molecular Formula	C16H24N2O·HCl
Molecular Weight	296.84 g/mol
Synonyms	6-tert-Butyl-3-(2-imidazolin-2-ylmethyl)-2,4-dimethylphenol hydrochloride; Oxymetazoline Impurity A; Oxymetazoline Related Compound A; EP Impurity A of Oxymetazoline HCl; 2-[(4-(1,1-Dimethylethyl)-2,6-dimethyl-3-hydroxyphenyl)methyl]-2-imidazoline hydrochloride; Afrin Impurity A
EINECS	Contact for details

Quality Control

Every batch of Oxymetazoline Hydrochloride Ep Impurity A is manufactured and handled under strict quality management systems. The material undergoes comprehensive analytical testing, including HPLC purity assay, identification by IR and NMR spectroscopy, residual solvent analysis, and precise quantification to ensure it meets the exacting standards required for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with each lot, confirming compliance with specified identity, purity, and strength parameters suitable for pharmacopoeial applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unspecified impurity ≤ 0.5%
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.