Description

Idelalisib Impurity 8 is a designated reference standard used for the analytical profiling and quality control of the pharmaceutical active ingredient, Idelalisib. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by enabling the accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical research and development laboratories, quality assurance/quality control (QA/QC) units, and regulatory compliance teams working with this targeted therapy.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for analytical method development, validation, and routine quality control testing of Idelalisib API and finished dosage forms.
• Regulatory Compliance & Filings: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) to establish impurity profiles and demonstrate control strategies in accordance with ICH Q3A and Q3B guidelines.
• Stability Studies: Used to monitor the formation and levels of this specific impurity during forced degradation and long-term stability studies of Idelalisib drug substance and product.
• Process Chemistry R&D: Employed by synthetic chemists to identify, track, and optimize reaction pathways to minimize the formation of this impurity during the manufacturing process.
• Pharmacopoeial Testing: Serves as a system suitability and identification standard for testing procedures potentially outlined in pharmacopoeias like USP or EP monographs for Idelalisib.
• Contract Research & Testing Labs: Essential reagent for CROs and analytical service providers offering impurity identification and characterization services to the pharmaceutical industry.

Basic Information

Product Name	Idelalisib Impurity 8
CAS No.	2044710-26-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	5-Fluoro-3-phenyl-2-[(1S)-1-(7H-purin-6-ylamino)propyl]quinazolin-4(3H)-one; Idelalisib Related Compound 8; GS-1101 Impurity 8; CAL-101 Impurity 8; PI3Kδ Inhibitor Impurity; Zydelig Impurity 8
EINECS	Contact for details

Quality Control

Every batch of Idelalisib Impurity 8 is manufactured and handled under strict quality management systems. The material undergoes comprehensive analytical characterization using advanced techniques such as HPLC, NMR, and MS to confirm identity and establish purity. A detailed Certificate of Analysis (COA) is provided with each lot, containing batch-specific data on purity, impurities, and chromatographic profiles. Our quality commitment aligns with the standards expected for pharmaceutical reference materials, supporting compliance with cGMP and ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a dry environment. For long-term storage, consider desiccants or storage under an inert atmosphere to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
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.