Description

Ap3 Impurity 1 (CAS NO 77714-98-8) is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a key impurity marker, essential for ensuring the quality, safety, and regulatory compliance of active pharmaceutical ingredients (APIs). It is primarily required by analytical laboratories and pharmaceutical manufacturers for method development, validation, and routine quality control testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Ap3-related drug substances and finished products.
• Analytical Method Development: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to monitor impurity levels.
• Quality Control & Assurance: Employed in routine QC testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines.
• Stability Studies: Acts as a benchmark in forced degradation and long-term stability studies to understand drug substance behavior.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate control over the manufacturing process.
• Research & Development: Supports synthetic route optimization and process chemistry by helping to identify and control process-related impurities.

Basic Information

Product Name	Ap3 Impurity 1
CAS No.	77714-98-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ap3 Related Compound A; Ap3 Process Impurity; Ap3 Specified Impurity; 1H-Pyrrolo[2,3-b]pyridine-5-carbonitrile, 2,3-dihydro-1-(phenylmethyl)- (IUPAC-based); Benzyl Dihydro-1H-pyrrolo[2,3-b]pyridine-5-carbonitrile; Pharmaceutical Intermediate Impurity; API Impurity Standard.
EINECS	Contact for details

Quality Control

Every batch of Ap3 Impurity 1 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, assay, and impurity profile is provided with each shipment, supporting compliance with cGMP and ICH 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). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Handle under an inert atmosphere if specified for long-term storage.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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