Description

Olprinone Impurity 7 is a designated impurity of the pharmaceutical compound Olprinone, a cardiotonic agent. This reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily used by researchers and quality assurance professionals in the pharmaceutical and biotechnology industries to ensure the purity, safety, and efficacy of Olprinone-based drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Olprinone Impurity 7 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling of Olprinone.
• Quality Control & Assurance: Used in routine batch testing to monitor impurity levels and ensure compliance with strict pharmacopeial (e.g., USP, EP, ICH) guidelines.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and control strategies.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions.
• Research & Development: Utilized in synthetic chemistry research to understand degradation pathways and improve the synthesis of Olprinone.

Basic Information

Product Name	Olprinone Impurity 7
CAS No.	2236020-10-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Olprinone Related Compound 7; Olprinone EP Impurity 7; Olprinone USP Impurity 7; 1,2-Dihydro-5-imidazo[1,2-a]pyridin-6-yl-6-methyl-2-oxo-3-pyridinecarbonitrile (Olprinone Impurity); Degradation Product of Olprinone; Olprinone Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Olprinone Impurity 7 is manufactured and handled under strict quality management systems. The product undergoes rigorous analytical testing, including HPLC for purity confirmation and spectroscopic methods for structural verification, 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.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material should be kept in a dry environment and handled with appropriate personal protective equipment in a well-ventilated laboratory setting.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 3.0%
Residual Solvents (GC)	Complies with ICH limits

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