Description

Sildenafil Impurity CAS NO 2640792-65-8 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. It is primarily required by analytical laboratories, quality control units, and research institutions involved in pharmaceutical development and manufacturing.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in sildenafil citrate active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, validating, and verifying HPLC, UPLC, and LC-MS methods in compliance with ICH Q2(R1) and other regulatory guidelines.
• Quality Control & Assurance: Employed in routine batch testing to monitor and control impurity profiles, ensuring drug substance and product meet pharmacopeial specifications (USP, EP, BP).
• Stability Studies: Used to track the formation and levels of this specific impurity during forced degradation and long-term stability testing of sildenafil formulations.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Serves as a key intermediate or impurity marker in synthetic chemistry research and process optimization for sildenafil manufacturing.

Basic Information

Item	Details
Product Name	Sildenafil Impurity
CAS No.	2640792-65-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sildenafil Related Compound; Sildenafil Process Impurity; Sildenafil Degradant; PDE5 Inhibitor Impurity; 1-[[3-(6,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine Impurity; Sildenafil Citrate Impurity; Sildenafil Analog
EINECS	Contact for details

Quality Control

Our Sildenafil Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including chromatographic purity assays and structural confirmation, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on identity, purity, and impurities.

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 must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.