Description

Pbt Impurity 1 CAS NO 210566-87-3 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. It is primarily utilized by researchers and quality control professionals in the pharmaceutical and biotechnology industries for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Used as a standard to develop and validate high-performance liquid chromatography (HPLC), ultra-performance liquid chromatography (UPLC), and mass spectrometry (MS) methods.
• Quality Control & Assurance: Essential for routine quality control testing in GMP environments to monitor and control impurity levels, ensuring batch-to-batch consistency.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive characterization data for impurities as required by ICH guidelines.
• Stability Studies: Employed to track the formation of degradation products in drug substances and products under various stress conditions.
• Research & Development: Used in synthetic chemistry R&D to study reaction pathways, by-product formation, and purification processes.

Basic Information

Item	Detail
Product Name	Pbt Impurity 1
CAS No.	210566-87-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	PBT Impurity 1; 210566-87-3; PBT Related Compound 1; PBT Impurity Standard; PBT Process Impurity; 1,3-Bis(4-aminophenoxy)benzene Impurity; BAPB Impurity; 4,4'-(1,3-Phenylenedioxy)dianiline Impurity
EINECS	Contact for details

Quality Control

Every batch of Pbt Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards and customer specifications. Certificates of Analysis (COA) with detailed chromatographic purity data are 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 this light-sensitive material from degradation.

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 single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH limits

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