Description

Roxatidine Impurity 7 is a specified impurity of the active pharmaceutical ingredient Roxatidine, a histamine H2-receptor antagonist. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Roxatidine-based drug substances and products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the identification and quantification of Roxatidine Impurity 7 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Crucial for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure API and drug product purity meets pharmacopeial (e.g., USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., CMC sections for FDA, EMA) by providing characterized impurity data.
• Process Chemistry Research: Aids in understanding and optimizing synthesis pathways to minimize the formation of this impurity during Roxatidine manufacturing.

Basic Information

Product Name	Roxatidine Impurity 7
CAS No.	876497-65-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Roxatidine Related Compound 7; Roxatidine EP Impurity 7; Roxatidine USP Impurity 7; Roxatidine Process Impurity; N-[3-[3-(1-Piperidinylmethyl)phenoxy]propyl]acetamide Impurity; Acetamide, N-[3-[3-[(1-piperidinyl)methyl]phenoxy]propyl]- (Related Substance); Roxatidine Degradation Product; Roxatidine Specified Impurity.
EINECS	Contact for details

Quality Control

Our Roxatidine Impurity 7 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and identity verification by spectroscopic methods (IR, NMR, MS). We provide comprehensive Certificates of Analysis (COA) with batch-specific data, ensuring traceability and compliance with current Good Manufacturing Practices (cGMP) and ICH guidelines for reference 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 material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. The container should be opened only in a controlled, low-humidity environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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