Description

Naphazoline Impurity D CAS NO 22126-67-6 is a specified impurity of the active pharmaceutical ingredient Naphazoline, a vasoconstrictor used in ophthalmic and nasal decongestant formulations. This compound is critical for pharmaceutical manufacturers and analytical laboratories engaged in method development, stability studies, and regulatory compliance for Naphazoline-based products. It is primarily used by quality control (QC) and research & development (R&D) teams in the pharmaceutical and fine chemical industries to ensure product safety and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Naphazoline Impurity D in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC, GC) to monitor impurity profiles.
• Stability Studies & Forced Degradation: Employed to understand degradation pathways of Naphazoline and to establish shelf-life specifications.
• Quality Control & Batch Release Testing: Serves as a system suitability standard to ensure analytical procedures are fit for purpose in routine QC testing.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., ANDA, NDA, CMC) to health authorities like the US FDA and EMA by providing impurity characterization data.
• Research on Pharmacopoeial Standards: Used in alignment with pharmacopoeial monographs (USP, EP, BP) for Naphazoline to ensure compliance with official compendia.

Basic Information

Product Name	Naphazoline Impurity D
CAS No.	22126-67-6
Molecular Formula	C14H14N2
Molecular Weight	210.28 g/mol
Synonyms	2-(1-Naphthylmethyl)-2-imidazoline; 2-[(Naphthalen-1-yl)methyl]-4,5-dihydro-1H-imidazole; 1H-Imidazole, 4,5-dihydro-2-[(1-naphthalenyl)methyl]-; Naphazoline Related Compound D; Naphazoline EP Impurity D; Naphazoline USP Impurity D
EINECS	Contact for details

Quality Control

Our Naphazoline Impurity D is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment. Our quality commitment aligns with cGMP principles and supports compliance with ICH Q3A/B guidelines on impurities.

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); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. 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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.