Description

Sildenafil Impurity C2 CAS NO 300547-20-0 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 sildenafil citrate. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of this well-characterized impurity standard is essential for maintaining stringent quality control in drug production.

Application

• Pharmaceutical Impurity Profiling and Identification in sildenafil citrate API and finished dosage forms.
• Analytical Method Development and Validation for HPLC, UPLC, and LC-MS systems.
• Quality Control and Stability Testing to monitor impurity levels throughout the drug shelf-life.
• Regulatory Compliance and Documentation for submissions to agencies like the FDA, EMA, and PMDA.
• Research and Development of sildenafil-based pharmaceuticals and related compounds.
• Calibration of Analytical Instruments to ensure accurate quantification of impurities.
• Reference Material for Pharmacopoeial Testing (e.g., USP, EP, BP monographs).
• Teaching and Academic Research in pharmaceutical chemistry and analytical sciences.

Basic Information

Product Name	Sildenafil Impurity C2
CAS No.	300547-20-0
Molecular Formula	C22H30N6O4S
Molecular Weight	474.58 g/mol
Synonyms	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 N-Oxide Impurity; Sildenafil EP Impurity C; UK-103,320 N-Oxide; Sildenafil Related Compound C2
EINECS	Contact for details

Quality Control

Every batch of Sildenafil Impurity C2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopoeial standards (USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for assay, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%

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