Description

Apremilast Impurity 5 is a designated impurity standard used in the pharmaceutical development and quality control of Apremilast, a key therapeutic agent. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a reference marker in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis and validation of Apremilast.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Apremilast Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating high-performance liquid chromatography (HPLC), UPLC, and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity profiles, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation and levels of this specific degradation product under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Aids in optimizing synthesis pathways by identifying and minimizing the formation of this impurity during manufacturing.

Basic Information

Product Name	Apremilast Impurity 5
CAS No.	200710-04-9
Molecular Formula	C22H24N2O7S
Molecular Weight	460.50 g/mol
Synonyms	N-[2-[(1S)-1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl]acetamide; Apremilast Related Compound 5; Otezla Impurity 5; CC-10004 Impurity 5; Phosphodiesterase 4 (PDE4) Inhibitor Impurity; (S)-N-(2-(1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)-1,3-dioxoisoindolin-4-yl)acetamide
EINECS	Contact for details

Quality Control

Our Apremilast Impurity 5 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, batch-specific results, and traceability. Our quality commitment aligns with ICH guidelines and supports cGMP compliance for our clients.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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