Description

Apremilast Impurity 32 is a designated impurity of the active pharmaceutical ingredient Apremilast, used for analytical reference and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance of Apremilast.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Apremilast Impurity 32 in drug substance and drug product testing.
• Method Development and Validation: Essential for developing and validating analytical methods, such as HPLC and UPLC, to monitor impurities during the manufacturing process.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific impurity over time and under various stress conditions.
• Quality Control (QC) Testing: A critical component in routine batch release testing to ensure Apremilast API and finished dosage forms meet stringent pharmacopeial (e.g., USP, EP) specifications.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity profiling and control strategies to agencies like the FDA and EMA.
• Research and Development: Supports process chemistry research to understand impurity formation pathways and optimize synthesis routes for cleaner API production.

Basic Information

Product Name	Apremilast Impurity 32
CAS No.	1824587-85-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Apremilast Related Compound 32; Apremilast Impurity C; Apremilast EP Impurity C; Apremilast Process Impurity; Otezla Impurity 32; CC-10004 Impurity 32; Phosphodiesterase 4 (PDE4) Inhibitor Impurity; N-[2-[(1S)-1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-1,3-dioxo-2,3-dihydro-1H-isoindol-4-yl]acetamide (Potential IUPAC)
EINECS	Contact for details

Quality Control

Our Apremilast Impurity 32 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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