Description

Apremilast Impurity 57 is a designated impurity reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Apremilast. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling precise identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance/control (QA/QC) units, and regulatory affairs teams involved in the development and manufacturing of Apremilast.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Apremilast Impurity 57 in API batches.
• Method Development and Validation: Critical for developing and validating robust analytical methods, such as HPLC and UPLC, for impurity profiling.
• Stability Studies: Used to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of Apremilast.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Quality Control Testing: Serves as a system suitability and calibration standard in routine QA/QC testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Process Chemistry Research: Aids in understanding and optimizing the Apremilast synthesis pathway to minimize the formation of this impurity.

Basic Information

Item	Details
Product Name	Apremilast Impurity 57
CAS No.	2487573-01-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apremilast Related Compound 57; Apremilast Impurity 57; Apremilast EP Impurity 57; Apremilast USP Impurity 57; Otezla Impurity 57; (2-((1S)-1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)-4-acetylaminoisoindoline-1,3-dione Impurity); 4-Acetylamino-2-(1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)isoindoline-1,3-dione Impurity
EINECS	Contact for details

Quality Control

Every batch of Apremilast Impurity 57 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic and spectroscopic techniques to ensure compliance with ICH Q3A, Q3B, and relevant pharmacopeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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) and must be kept under dry conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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