Description

Acetate Impurity CAS NO 219718-02-2 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 and advanced materials. It is primarily required by analytical laboratories, quality control departments, and R&D teams in the pharmaceutical, biotechnology, and fine chemical sectors for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard: Used for the identification, quantification, and qualification of process-related impurities and degradation products in Active Pharmaceutical Ingredients (APIs) and drug products.
• Analytical Method Development & Validation (HPLC/GC): Serves as a critical system suitability and calibration standard to ensure the accuracy and precision of chromatographic methods.
• Quality Control & Assurance: Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with pharmacopeial standards (USP, EP, ICH Q3A/B).
• Stability Studies: Used as a marker to track and understand degradation pathways of drug substances under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Synthesis: Acts as a building block or intermediate in the research-scale synthesis of novel chemical entities or for metabolic studies.

Basic Information

Product Name	Acetate Impurity
CAS No.	219718-02-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Acetate Related Compound; Acetate Process Impurity; 219718-02-2; Acetate Derivative Impurity; Pharmaceutical Impurity Standard; Analytical Reference Standard; Chemical Impurity CAS 219718-02-2
EINECS	Contact for details

Quality Control

Our Acetate Impurity CAS NO 219718-02-2 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity assays and identity confirmation, to ensure it meets the stringent requirements for reference standards. A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with specified purity criteria and relevant guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Handle with appropriate laboratory safety practices.

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.