Description

Olprinone Impurity A is a designated reference standard used for the analytical profiling and quality control of the pharmaceutical active ingredient, Olprinone. This compound is critical for ensuring the purity, safety, and efficacy of Olprinone-based drug formulations by serving as a key marker for identification and quantification during manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality assurance/control (QA/QC) departments, and contract research organizations (CROs) involved in the development and production of cardiovascular medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Olprinone API and finished dosage forms.
• Analytical Method Development: Used in HPLC, UPLC, and LC-MS methods to establish retention times, calibration curves, and detection limits for this specific impurity.
• Stability Studies: Employed to monitor the formation and level of Olprinone Impurity A in drug products under various stress conditions (e.g., heat, humidity, light) to determine shelf life.
• Regulatory Compliance & Documentation: Essential for generating impurity profiles and reports required for regulatory submissions to agencies like the FDA, EMA, and PMDA.
• Pharmacopoeial Testing: Used to comply with testing protocols outlined in pharmacopoeias (e.g., USP, EP, JP) for impurity identification and limits.
• Process Chemistry Optimization: Helps chemical engineers and process chemists identify and minimize the formation of this impurity during the synthesis and purification of Olprinone.

Basic Information

Product Name	Olprinone Impurity A
CAS No.	141354-29-2
Molecular Formula	C₁₄H₁₀N₄O₂
Molecular Weight	266.26 g/mol
Synonyms	1,2-Dihydro-6-methyl-2-oxo-5-(imidazo[1,2-a]pyridin-6-yl)-3-pyridinecarbonitrile; 5-(Imidazo[1,2-a]pyridin-6-yl)-6-methyl-2-oxo-1,2-dihydropyridine-3-carbonitrile; Olprinone Related Compound A; Olprinone EP Impurity A; Olprinone USP Impurity A
EINECS	Contact for details

Quality Control

Every batch of Olprinone Impurity A is manufactured and handled under strict quality management systems. The product undergoes comprehensive analytical testing, including HPLC for purity confirmation and spectroscopic methods (NMR, MS) for structural verification, to ensure it meets the high standards required for pharmaceutical impurity analysis. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.