Description

Pramoxine Impurity 6 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 the active pharmaceutical ingredient Pramoxine Hydrochloride. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Pramoxine Hydrochloride drug substance and finished products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or GC methods to monitor impurities during manufacturing and stability studies.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to ensure batch-to-batch consistency and that impurity levels remain within specified limits (ICH guidelines).
• Regulatory Compliance & Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Stability Studies: Used to track the formation of this specific impurity over time under various stress conditions (thermal, photolytic, hydrolytic).
• Research & Development: Supports synthetic chemistry research aimed at understanding degradation pathways and improving the synthesis of Pramoxine.

Basic Information

Product Name	Pramoxine Impurity 6
CAS No.	100117-71-3
Molecular Formula	C17H27NO3
Molecular Weight	293.41 g/mol
Synonyms	4-[3-(4-Butoxyphenoxy)propyl]morpholine; 4-[3-(p-Butoxyphenoxy)propyl]morpholine; Pramoxine Related Compound; Pramoxine Impurity; Pramoxine EP Impurity; Pramoxine USP Impurity; Pramoxine Hydrochloride Impurity 6
EINECS	Contact for details

Quality Control

Every batch of Pramoxine Impurity 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity screening to ensure they meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC, NMR, and mass spectrometry. We support compliance with ICH Q3A/B guidelines and can supply materials suitable for USP/EP monograph testing.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure maximum stability.

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)	Any individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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