Description

Bpox Impurity 4 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 pharmaceutical products by serving as a known impurity marker. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) units, and contract research organizations (CROs) involved in method development, validation, and stability studies.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify related substances in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods, such as HPLC and UPLC, to ensure specificity and accuracy.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of degradation products under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Quality Control and Batch Release Testing: Serves as a system suitability standard and for preparing calibration curves to confirm the impurity levels in production batches meet regulatory specifications.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Academic and Industrial Research: Supports research into drug metabolism, pharmacokinetics, and the synthesis pathways of complex organic molecules.

Basic Information

Product Name	Bpox Impurity 4
CAS No.	15833-17-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	BPOX Impurity 4; 1,3-Diphenyl-2-propanone impurity; Dibenzyl ketone related compound; 1,3-Diphenylpropan-2-one impurity; CAS 15833-17-7; Benzyl phenyl ketone derivative; Desoxybenzoin analog
EINECS	Contact for details

Quality Control

Every batch of Bpox Impurity 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry, well-ventilated area. Keep the container sealed to protect the integrity of the reference standard.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH guidelines

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