Description

Sildenafil Impurity CAS NO 332374-45-5 is a high-purity chemical 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 utilized 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 the stringent purity requirements of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity in sildenafil API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods to ensure accurate detection and quantification limits.
• Quality Control and Assurance (QC/QA): Employed in routine quality control testing of sildenafil batches to verify compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B guidelines).
• Stability Studies: Used to track the formation and level of this impurity during forced degradation and long-term stability studies of sildenafil products.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research and Development: Facilitates research into the synthesis, degradation pathways, and toxicological profile of sildenafil-related substances.

Basic Information

Product Name	Sildenafil Impurity
CAS No.	332374-45-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	5-[2-Ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl]-1-methyl-3-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one; Sildenafil Related Compound; Sildenafil Degradant; Sildenafil Process Impurity; UK-103,320 Impurity; PDE5 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Our Sildenafil Impurity is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical reference materials. Each batch is subjected to comprehensive analytical testing, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC, UPLC). A Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant guidelines. We support compliance with ICH Q3A, Q3B, USP, and EP requirements for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F), in a dry environment. For long-term storage, consider storing desiccated at 2-8°C. Handle the material in accordance with good laboratory practices.

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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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