Description

Methisosildenafil Impurity is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing related active pharmaceutical ingredients (APIs). It is primarily required by analytical laboratories and R&D departments within the pharmaceutical and biotechnology industries for method development, validation, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Methisosildenafil or related drug substances and finished products.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS/MS methods in quality control laboratories.
• Impurity Profiling and Characterization: Supports stability studies and degradation pathway analysis to meet ICH Q3A(R2) and Q3B(R2) guidelines for impurities in new drug substances and products.
• Regulatory Compliance and Filing: Provides necessary data for regulatory submissions to agencies like the FDA, EMA, and PMDA, ensuring adherence to strict pharmacopeial standards.
• Research and Development: Utilized in synthetic chemistry research to study reaction pathways and to support the synthesis of high-purity APIs.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability standard and for routine batch release testing in manufacturing environments.

Basic Information

Product Name	Methisosildenafil Impurity
CAS No.	1873303-87-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Methisosildenafil Related Compound; Methisosildenafil Impurity Standard; Sildenafil Methyl Impurity; PDE5 Inhibitor Impurity; 1873303-87-7; (6R,9aS)-5-methyl-2,4,6,7,8,9,9a,10-octahydro-1H-pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,3(2H)-dione derivative (related to Methisosildenafil); API Impurity 1873303-87-7
EINECS	Contact for details

Quality Control

Every batch of Methisosildenafil Impurity CAS 1873303-87-7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced chromatographic and spectroscopic techniques (e.g., HPLC, GC, NMR, MS) to ensure compliance with industry and client-specific standards. 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 in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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