Description

Aidi Api Impurities CAS NO 1809782-41-9 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 active pharmaceutical ingredients (APIs) by serving as a benchmark for impurity identification and quantification. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug development and quality control. The material is supplied with comprehensive analytical data to support method validation and regulatory submissions.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Active Pharmaceutical Ingredients (APIs) during method development and validation.
• Quality Control (QC) Testing: Essential for routine batch release testing in pharmaceutical manufacturing to ensure product purity meets pharmacopeial standards (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to monitor the formation of degradation products in drug substances and finished products under various stress conditions.
• Regulatory Compliance & Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and control strategies.
• Analytical Research & Method Development: Serves as a critical tool in academic and industrial research for developing and optimizing chromatographic (HPLC, GC) and spectroscopic analytical methods.
• Calibration Standard: Used to calibrate analytical instruments to ensure accurate and reproducible measurement of impurity levels.

Basic Information

Product Name	Aidi Api Impurities CAS NO 1809782-41-9
CAS No.	1809782-41-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Aidi Impurity; API Impurity 1809782-41-9; Pharmaceutical Impurity Standard; Reference Impurity Standard; Analytical Reference Standard; Drug Impurity; ICH Impurity; Degradation Product Standard
EINECS	Contact for details

Quality Control

Our Aidi Api Impurities are manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity analysis and spectroscopic identification, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and assay. Our quality commitment aligns with the principles of ICH Q7 and relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.