Description

Acetylsalicylic Acid Impurity 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 acetylsalicylic acid (aspirin) and related pharmaceutical products. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Acetylsalicylic Acid (Aspirin) Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, and GC methods for stability-indicating assays and related substance testing.
• Quality Control & Assurance (QC/QA): Employed in routine quality control laboratories to monitor batch-to-batch consistency and ensure product purity meets pharmacopeial standards (USP, EP, BP).
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Stability Studies: Used to track the formation and level of this specific impurity during forced degradation and long-term stability studies of aspirin formulations.
• Research & Development: Aids in synthetic chemistry research, metabolic studies, and the investigation of degradation pathways for salicylate-based drugs.

Basic Information

Product Name	Acetylsalicylic Acid Impurity 2
CAS No.	318515-20-7
Molecular Formula	C9H8O4
Molecular Weight	180.16 g/mol
Synonyms	2-Acetoxybenzoic Acid Related Compound; Aspirin Impurity 2; 2-(Acetyloxy)benzoic Acid Impurity; Salicylic Acid Acetate Impurity; ASA Impurity 2; Benzoic acid, 2-(acetyloxy)-, impurity; (2-Carboxyphenyl) acetate impurity
EINECS	Contact for details

Quality Control

Every batch of Acetylsalicylic Acid Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for purity, related substances, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 0.5% 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.