Description

Apremilast Impurity 25 is a designated impurity standard used in the pharmaceutical development and quality control of Apremilast, a key therapeutic agent. This high-purity reference material is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of process-related impurities. It is primarily required by analytical laboratories, pharmaceutical R&D teams, and quality assurance departments involved in the synthesis and validation of Apremilast.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the analytical method development and validation of Apremilast drug substance and product.
• Quality Control & Assurance: Used in routine batch testing to monitor and control the levels of this specific impurity, ensuring it remains within ICH-prescribed limits.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to characterize and justify impurity profiles.
• Stability Studies: Employed as a marker to track impurity formation and degradation pathways in Apremilast formulations under various storage conditions.
• Process Chemistry R&D: Aids chemists in optimizing synthesis routes to minimize the formation of this impurity during Apremilast manufacturing.
• Pharmacopoeial Testing: Can be utilized as a working standard for testing against monographs in pharmacopoeias like USP or EP.

Basic Information

Product Name	Apremilast Impurity 25
CAS No.	2096492-44-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apremilast Related Compound 25; Apremilast Impurity F; Otezla Impurity 25; (S)-N-(2-((1S)-1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)-1,3-dioxoisoindolin-4-yl)acetamide (tentative); Apremilast Process Impurity; CC-10004 Impurity 25
EINECS	Contact for details

Quality Control

Every batch of Apremilast Impurity 25 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC and MS to ensure compliance with pharmaceutical reference standard requirements. 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). Due to its hygroscopic nature, the container must be kept in a desiccated environment to prevent moisture uptake, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
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.