Description

Aidi Api Impurities CAS NO 147088-10-6 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development. This impurity is critical for ensuring the safety and efficacy of active pharmaceutical ingredients (APIs) by enabling accurate identification and quantification of related substances. It is primarily utilized by research scientists and quality assurance professionals in the pharmaceutical and biotechnology industries for method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in active pharmaceutical ingredients (APIs) during method development and validation.
• Quality Control & Assurance (QC/QA): Serves as a critical standard in HPLC, UPLC, and GC analyses to monitor impurity levels and ensure batch-to-batch consistency of final drug products.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of drug stability and shelf-life determination programs.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA, ICH) by providing definitive characterization data for specified and unspecified impurities.
• Research & Development (R&D): Used in synthetic chemistry research to understand degradation pathways and to develop purification processes that minimize impurity formation.
• Pharmacopoeial Testing: Applied as a reference standard to comply with testing methodologies outlined in pharmacopoeias such as USP, EP, and JP.

Basic Information

Product Name	Aidi Api Impurities CAS NO 147088-10-6
CAS No.	147088-10-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	147088-10-6; Aidi Impurity; API Impurity Standard; Pharmaceutical Impurity; Related Substance; Degradation Product; Chemical Reference Standard; Analytical Standard.
EINECS	Contact for details

Quality Control

Every batch of Aidi Api Impurities CAS NO 147088-10-6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced chromatographic and spectroscopic techniques (e.g., HPLC, GC, NMR, MS) to ensure they meet the exacting standards required for pharmaceutical analysis. Certificates of Analysis (COA) containing batch-specific data are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 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 desiccants or 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 single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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