Description

Acetylsalicylic Acid Impurity 5 is a high-purity chemical reference standard, specifically identified as a process-related impurity of acetylsalicylic acid (aspirin). This compound is critical for pharmaceutical research and development, enabling precise analytical method development, validation, and quality control of active pharmaceutical ingredients (APIs). It is primarily utilized by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical, biotechnology, and contract research organization (CRO) sectors to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify this specific impurity in acetylsalicylic acid API and finished dosage forms.
• Analytical Method Development and Validation (HPLC/GC): Serves as a critical standard for developing, optimizing, and validating chromatographic methods for impurity detection in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this impurity under various stress conditions (e.g., heat, humidity, light) to establish product shelf-life and packaging requirements.
• Quality Control and Release Testing: Essential for in-house QC laboratories to set specification limits and perform routine batch analysis of aspirin and related pharmaceutical products.
• Regulatory Submissions and Compliance: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Academic and Clinical Research: Supports fundamental research on aspirin metabolism, pharmacokinetics, and the pharmacological impact of its degradation products.

Basic Information

Product Name	Acetylsalicylic Acid Impurity 5
CAS No.	18698-59-4
Molecular Formula	C9H8O4
Molecular Weight	180.16 g/mol
Synonyms	2-Acetoxybenzoic Acid Impurity 5; Aspirin Impurity 5; 2-(Acetyloxy)benzoic Acid Related Compound 5; Salicylic Acid Acetate Impurity; O-Acetylsalicylic Acid Impurity 5; ASA Impurity 5; Benzoic acid, 2-(acetyloxy)- (impurity)
EINECS	Contact for details

Quality Control

Every batch of Acetylsalicylic Acid Impurity 5 is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and mass spectrometry to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH guidelines and can supply materials suitable for use in regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); ensure the container is kept tightly sealed in a low-humidity environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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