Description

Sildenafil Impurity 23 is a designated pharmaceutical reference standard used for analytical and research purposes. This compound is critical for ensuring the purity, safety, and efficacy of Sildenafil-based drug products through rigorous quality control testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The availability of a well-characterized impurity standard is essential for compliance with stringent global pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Sildenafil and its related substances.
• Impurity Profiling & Identification: Essential for identifying and quantifying this specific impurity in Sildenafil Active Pharmaceutical Ingredient (API) and finished drug formulations.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for stability-indicating assays.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure drug substance and product meet specified impurity limits per ICH guidelines.
• Stability Studies: Used to monitor the formation of this impurity under various stress conditions (e.g., heat, light, humidity) as part of forced degradation studies.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough understanding and control of the impurity profile.
• Research & Development: Utilized in pharmaceutical R&D for studying degradation pathways and synthesis process optimization.

Basic Information

Product Name	Sildenafil Impurity 23
CAS No.	1797861-66-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Sildenafil Related Compound 23; Sildenafil EP Impurity J; Sildenafil USP 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; Sildenafil Degradant; Sildenafil Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Sildenafil Impurity 23 is manufactured and controlled under strict quality management systems. Our products undergo rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and conformity to the highest standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material 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 solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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