Description

Sildenafil Impurity Iv-1 is a high-purity reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of active pharmaceutical ingredients (APIs) by accurately identifying and quantifying related substances. It is an essential tool for analytical chemists, quality assurance professionals, and researchers working in pharmaceutical R&D and production, particularly for the development and validation of sildenafil and related products.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in sildenafil citrate API and finished dosage forms.
• Analytical Method Development & Validation: Critical component for developing, optimizing, and validating HPLC, UPLC, and other chromatographic methods in QC laboratories.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing definitive impurity profiling data.
• Stability Studies & Forced Degradation: Used to monitor impurity formation and profile changes during drug product stability testing and forced degradation studies.
• Pharmacopoeial Testing: Aids in compliance testing against monographs in pharmacopoeias such as USP, EP, and BP.
• Research & Development: Serves as a key intermediate or marker in the synthetic pathway research and impurity synthesis studies for sildenafil.

Basic Information

Product Name	Sildenafil Impurity Iv-1
CAS No.	1308332-48-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sildenafil Related Compound IV-1; Sildenafil Impurity 4; Sildenafil EP Impurity I; 1-[[3-(6,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine; Sildenafil Sulfoxide N-Oxide Impurity; Sildenafil Metabolite Related Impurity; PDE5 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Sildenafil Impurity Iv-1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards and precise impurity profiling requirements. Certificates of Analysis (COA) with detailed chromatographic purity, identity confirmation (IR, NMR, MS), and impurity data are provided and available upon request.

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 material is hygroscopic (moisture-sensitive) and light-sensitive; containers must be kept tightly sealed in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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