Description

Apremilast Impurity 29 is a designated impurity of the active pharmaceutical ingredient Apremilast, a key medication used in the treatment of psoriasis and psoriatic arthritis. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, validation, and quality control processes. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Apremilast drug substances and finished products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Apremilast API and finished dosage forms.
• Analytical Method Development: Crucial for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance: Used in routine batch testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed to track the formation of degradation products under various stress conditions.
• Process Chemistry Research: Aids in understanding and optimizing the synthesis pathway of Apremilast to minimize impurity formation.

Basic Information

Product Name	Apremilast Impurity 29
CAS No.	2096492-42-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apremilast Related Compound 29; Apremilast Impurity K; Apremilast EP Impurity K; Apremilast Process Impurity; Otezla Impurity 29; (2-((1S)-1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)-5-acetamidoisoindoline-1,3-dione) (Tentative); UNII-Contact for details
EINECS	Contact for details

Quality Control

Every batch of Apremilast Impurity 29 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure compliance with pharmacopeial standards (e.g., USP, EP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing at 2-8°C. Handle the material under appropriate laboratory conditions to prevent contamination.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
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.