Description

Roxatidine Impurity 9 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Roxatidine. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Roxatidine Impurity 9 in Roxatidine Acetate API and related drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities during API synthesis and purification processes.
• Quality Control & Assurance: Employed in routine QC testing of raw materials, in-process samples, and finished drug products to ensure compliance with pharmacopeial limits (e.g., ICH Q3A/B).
• Stability Studies: Used as a marker to track impurity profiles and degradation pathways in stability-indicating assay methods for Roxatidine formulations.
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development: Supports synthetic route optimization and impurity fate and tolerance studies during the drug development lifecycle.

Basic Information

Product Name	Roxatidine Impurity 9
CAS No.	87327-60-4
Molecular Formula	C19H28N2O4
Molecular Weight	348.44 g/mol
Synonyms	N-[3-[3-(1-Piperidinylmethyl)phenoxy]propyl]acetamide; Roxatidine Related Compound; Roxatidine EP Impurity B; Roxatidine Acetate Impurity; 2-Acetamidoethyl 3-(1-Piperidinylmethyl)phenyl Ether; UNII-6F3T8F3V4I
EINECS	Contact for details

Quality Control

Our Roxatidine Impurity 9 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing to ensure identity, purity, and consistency, aligning with current pharmacopeial standards (e.g., EP, USP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing the results of all specified tests, including chromatographic purity, assay, and identification.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC)	≥ 98.0%
Single Unknown Impurity	≤ 0.5%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C

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