Description

Sildenafil Impurity 10 CAS NO 1393816-99-3 is a high-purity reference standard used for the identification, qualification, and quantification of a specific process-related impurity in Sildenafil Citrate active pharmaceutical ingredient (API) and finished drug products. This compound is critical for pharmaceutical quality control and regulatory compliance, ensuring the safety and efficacy of the final medication. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies involved in the development, production, and quality assurance of Sildenafil-based therapeutics.

Application

• Pharmaceutical Impurity Profiling and Control: Used as a certified reference material (CRM) for the accurate analysis of Sildenafil API and formulations.
• Method Development and Validation: Essential for developing and validating stability-indicating analytical methods, such as HPLC and UPLC.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing impurity identification and qualification data.
• Quality Control (QC) Testing: Serves as a system suitability standard and for routine batch release testing in QC laboratories.
• Stability Studies: Employed to monitor impurity levels in Sildenafil products under various stress and long-term storage conditions.
• Research and Development (R&D): Used in process chemistry R&D to understand and minimize the formation of this impurity during synthesis.

Basic Information

Product Name	Sildenafil Impurity 10
CAS No.	1393816-99-3
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 10; Sildenafil EP Impurity I; Sildenafil USP Impurity 10; UK-103,320 Impurity; 5-[2-Ethoxy-5-(4-methylpiperazin-1-ylsulfonyl)phenyl]-1-methyl-3-propyl-6,7-dihydro-1H-pyrazolo[4,3-d]pyrimidin-7-one Impurity
EINECS	Contact for details

Quality Control

Every batch of Sildenafil Impurity 10 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards (USP, EP) and customer specifications. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, ensuring full traceability and regulatory readiness for your pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. Keep the container tightly sealed after each use.

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.