Description

Roxatidine Acetate Impurity 2 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 (API) Roxatidine Acetate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method development, validation, and impurity profiling.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Roxatidine Acetate API.
• Essential for pharmaceutical quality control (QC) and quality assurance (QA) processes to meet ICH guidelines.
• Critical component in analytical method development and validation (e.g., HPLC, UPLC, GC).
• Used in stability studies to monitor impurity profiles over time under various storage conditions.
• Supplies regulatory documentation and submissions (e.g., for FDA, EMA) requiring impurity characterization.
• Valuable for academic and industrial research into the synthesis and degradation pathways of Roxatidine Acetate.

Basic Information

Product Name	Roxatidine Acetate Impurity 2
CAS No.	97900-87-3
Molecular Formula	C19H28N2O4
Molecular Weight	348.44 g/mol
Synonyms	Roxatidine Related Compound 2; Roxatidine EP Impurity B; Roxatidine Acetate Related Substance 2; 2-[[[2-(1-Piperidinylmethyl)-1-cyclohexen-1-yl]acetyl]amino]-3-(1H-1,2,4-triazol-1-yl)propyl Acetate; Roxatidine Impurity; Roxatidine Acetate Impurity B; Roxatidine Acetate Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Roxatidine Acetate Impurity 2 is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with industry standards and pharmacopeial requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profiles.

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 light-sensitive and should be handled accordingly to maintain 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)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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