Description

Salicylic Acid Impurity 46 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 salicylic acid and related pharmaceutical products. It is primarily needed by analytical laboratories, pharmaceutical R&D departments, and quality control units for method development, validation, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in salicylic acid Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurities in compliance with ICH Q3B (R2) guidelines.
• Quality Control & Assurance: Serves as a system suitability and calibration standard in routine QC testing to ensure batch-to-batch consistency and purity of salicylic acid.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation and levels of this specific impurity over time.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Synthesis: Used in academic and industrial research to study the metabolic pathways, degradation profiles, and synthesis of salicylic acid derivatives.

Basic Information

Product Name	Salicylic Acid Impurity 46
CAS No.	1172605-63-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Salicylic Acid Related Compound 46; 1172605-63-8; Salicylic Acid Impurity; Salicylic Acid EP Impurity 46; Salicylic Acid USP Impurity; Salicylic Acid Process Impurity; 2-Hydroxybenzoic Acid Impurity 46
EINECS	Contact for details

Quality Control

Our Salicylic Acid Impurity 46 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity and identity confirmation, to ensure it meets the high standards required for reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for traceability and compliance.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to Off-white Solid
Identification (IR)	Conforms to Reference Spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual Unknown Impurity: ≤ 1.0% Total Impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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