Description

Bar 501 Impurity is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products by serving as a benchmark in impurity profiling and method validation. It is primarily needed by pharmaceutical R&D laboratories, quality control (QC) departments, and contract research organizations (CROs) involved in the development and manufacturing of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of process-related impurities in active pharmaceutical ingredients (APIs).
• Analytical Method Development and Validation: Essential for developing, calibrating, and validating chromatographic methods such as HPLC and UPLC to ensure accuracy and specificity.
• Quality Control and Assurance: Serves as a critical tool in QC laboratories to monitor batch-to-batch consistency and ensure final product purity meets pharmacopeial standards (e.g., USP, ICH Q3A/B).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research and Development: Supports synthetic route optimization and process chemistry studies by identifying and characterizing synthetic intermediates and by-products.

Basic Information

Product Name	Bar 501 Impurity
CAS No.	1632118-70-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	BAR 501 Impurity; BAR-501 Related Compound; 1632118-70-7; Bar 501 Related Substance; Bar501 Impurity; API Intermediate Bar 501 Impurity; Pharmaceutical Impurity Bar 501
EINECS	Contact for details

Quality Control

Our Bar 501 Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assays and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatograms and spectral data are available upon request to support your compliance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Keep the container sealed to prevent moisture absorption and contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.