Description

Sildenafil Impurity CAS NO 1971915-89-5 is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Sildenafil-based active pharmaceutical ingredients (APIs). This impurity is critical for ensuring the safety, efficacy, and regulatory compliance of the final drug product by enabling accurate identification and quantification of related substances. It is an essential tool for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material to identify and quantify this specific impurity in Sildenafil citrate API and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for purity analysis.
• Stability Studies and Forced Degradation Testing: Employed to monitor the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to establish product shelf-life.
• Regulatory Submission and Compliance: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity control and meet ICH Q3A/B guidelines.
• Quality Control (QC) Testing: Used in routine QC laboratories as a system suitability standard and for quantitative impurity testing of production batches.
• Pharmacopoeial Standards: Supports compliance with monograph specifications in pharmacopoeias such as USP, EP, or BP where this impurity is controlled.

Basic Information

Product Name	Sildenafil Impurity
CAS No.	1971915-89-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sildenafil Related Compound; Sildenafil Process Impurity; Sildenafil Degradant; Sildenafil Citrate Impurity; PDE5 Inhibitor Impurity; Viagra 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
EINECS	Contact for details

Quality Control

Our Sildenafil Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure high purity and accurate identification. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, assay, and impurity profile. Our quality standards align with ICH guidelines and support requirements for cGMP manufacturing environments.

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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