Description

Sildenafil Impurity 13 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Sildenafil Citrate and its related drug products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and batch release testing. The use of this well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Sildenafil API and finished dosage forms.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine QC analysis to ensure drug substance and product meet ICH Q3A(R2) and Q3B(R2) guidelines for impurities.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., DMF, CMC sections) by providing data on impurity characterization and control strategies.
• Stability Studies: Employed to monitor impurity levels in stability samples to assess drug product shelf-life and degradation pathways.
• Research & Development: Used in process chemistry R&D to understand and control the formation of this impurity during API synthesis.

Basic Information

Product Name	Sildenafil Impurity 13
CAS No.	76424-56-1
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 Related Compound 13; Sildenafil EP Impurity G; Sildenafil USP Impurity 13; UK-103,320 Impurity; 5-[2-Ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl]-1-methyl-3-propyl-6,7-dihydro-1H-pyrazolo[4,3-d]pyrimidin-7-one
EINECS	Contact for details

Quality Control

Our Sildenafil Impurity 13 is manufactured and tested under strict quality management systems. Each batch is characterized using advanced analytical techniques including HPLC, LC-MS, and NMR to ensure high purity and structural identity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile. Our quality standards are designed to meet the requirements of pharmaceutical reference material applications.

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 prevent degradation. For long-term storage, consider desiccated conditions.

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%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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