Description

Oxymetazoline Hydrochloride Impurity (CAS NO 55699-13-3) is a high-purity reference standard critical for analytical and regulatory purposes in the pharmaceutical industry. This compound is essential for the accurate identification, quantification, and control of impurities during the development and manufacturing of Oxymetazoline HCl, a widely used nasal decongestant. It serves as a vital tool for quality assurance and compliance teams in pharmaceutical companies and contract research organizations (CROs) to ensure drug safety and meet stringent regulatory standards set by agencies like the FDA and EMA.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for method development, validation, and routine quality control testing of Oxymetazoline Hydrochloride API and finished drug products.
• Impurity Profiling and Identification: Critical for characterizing the impurity profile of Oxymetazoline HCl, aiding in stability studies and forced degradation studies to understand drug degradation pathways.
• Regulatory Compliance and Filing: Supports the preparation of regulatory submission documents (e.g., CMC sections for FDA, EMA) by providing definitive impurity identification and specification data.
• Analytical Method Development: Serves as a key component in developing and optimizing chromatographic methods, such as HPLC and UPLC, for precise impurity separation and analysis.
• Pharmacopoeial Testing: Used to verify compliance with purity specifications outlined in pharmacopoeias like USP (United States Pharmacopeia) and EP (European Pharmacopoeia).
• Stability-Indicating Studies: Employed in assays to demonstrate the specificity of analytical methods for the accurate measurement of the active pharmaceutical ingredient (API) in the presence of its degradation products.
• Contract Research and Manufacturing (CRO/CMO): Essential for third-party testing laboratories and manufacturers to ensure batch-to-batch consistency and quality for their clients.

Basic Information

Product Name	Oxymetazoline Hydrochloride Impurity
CAS No.	55699-13-3
Molecular Formula	C16H24N2O·HCl
Molecular Weight	296.84 g/mol
Synonyms	6-tert-Butyl-3-(2-imidazolin-2-ylmethyl)-2,4-dimethylphenol hydrochloride; 2-[(4-tert-Butyl-2,6-dimethyl-3-hydroxyphenyl)methyl]-4,5-dihydro-1H-imidazole hydrochloride; Oxymetazoline Related Compound; Oxymetazoline HCl Impurity; Oxymetazoline Hydrochloride Related Substance; Afrin Impurity
EINECS	Contact for details

Quality Control

Every batch of Oxymetazoline Hydrochloride Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for purity, related substances, residual solvents, and other critical parameters. We support compliance with cGMP guidelines and relevant pharmacopoeial standards.

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 product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a dry environment and protected from light exposure to maintain stability and purity.

Specification

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