Description

Iso Sildenafil CAS NO 253178-46-0 is a high-purity pharmaceutical intermediate and reference standard, specifically an isomer of the well-known active pharmaceutical ingredient Sildenafil. This compound is of critical importance for research and development, quality control, and analytical method validation within the pharmaceutical industry. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in the development, production, and testing of PDE5 inhibitor-based therapeutics.

Application

• Pharmaceutical Reference Standard: Used for qualitative and quantitative analysis, including method development and validation in HPLC, LC-MS, and other chromatographic systems.
• Impurity Profiling: Serves as a critical isomer impurity standard to ensure the purity and safety of Sildenafil API and finished dosage forms.
• Research & Development: Employed in preclinical and clinical research to study the structure-activity relationships (SAR) of PDE5 inhibitors.
• Quality Control (QC) Testing: Essential for in-process control and release testing of Sildenafil citrate bulk drug and formulated products to meet pharmacopeial standards.
• Regulatory Submissions: Provides necessary data and standards for regulatory filings (e.g., with FDA, EMA) to demonstrate product quality and impurity control.
• Academic Research: Used in university and institutional labs for biochemical and pharmacological studies related to erectile dysfunction and pulmonary arterial hypertension treatments.

Basic Information

Product Name	Iso Sildenafil
CAS No.	253178-46-0
Molecular Formula	C22H30N6O4S
Molecular Weight	474.58 g/mol
Synonyms	UK-103,320; Sildenafil Impurity F; Isosildenafil; 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; UK 103320; PDE5 Inhibitor Isomer
EINECS	Contact for details

Quality Control

Our Iso Sildenafil is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification by IR and NMR, purity determination by HPLC, and control of specific impurities. We provide full traceability and Certificates of Analysis (COA) that detail all test results against stringent in-house specifications, ensuring compliance with ICH guidelines for impurities in pharmaceutical substances.

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 product 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 reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 1.0%

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