Description

Apremilast Impurity Hs093313 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 related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, purification, and batch release 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 (QC/QA): Used in routine batch testing to monitor and control the levels of this specific impurity, ensuring it remains within acceptable limits as per ICH guidelines.
• Regulatory Compliance & Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to characterize and justify the impurity profile of Apremilast.
• Stability Studies: Employed to track the formation or increase of this impurity over time under various stress conditions, supporting shelf-life determination.
• Process Chemistry R&D: Used by research scientists to optimize synthesis and purification processes to minimize the formation of this impurity.
• Pharmacopoeial Testing: Acts as a system suitability standard in chromatographic assays as per pharmacopoeial monographs (e.g., USP, EP).

Basic Information

Product Name	Apremilast Impurity Hs093313
CAS No.	2077897-93-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Hs093313; Apremilast Related Compound Hs093313; Apremilast Impurity 7; Apremilast EP Impurity G; Apremilast Process Impurity; (S)-2-((S)-1-(3-Ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl)-4-acetylaminoisoindoline-1,3-dione (tentative); Apremilast API Impurity.
EINECS	Contact for details

Quality Control

Every batch of Apremilast Impurity Hs093313 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, and NMR to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with cGMP and ICH Q3A/B guidelines.

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 should be kept in a desiccated environment to prevent moisture uptake, which could affect stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
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% w/w

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