Description

2-Hydroxypropyl Nortadalafil is a high-purity pharmaceutical intermediate and reference standard, identified by CAS NO 1353020-85-5. This compound is critical for research and development in the synthesis of advanced active pharmaceutical ingredients (APIs), particularly in the urology and cardiology therapeutic areas. It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories requiring precise and reliable chemical building blocks for drug discovery and quality control processes.

Application

• Pharmaceutical Intermediate: A key synthetic precursor in the manufacture of novel PDE5 inhibitor-based APIs.
• Reference Standard: Used for analytical method development, validation, and quality control testing in pharmaceutical laboratories.
• Research & Development: Serves as a critical compound in medicinal chemistry for structure-activity relationship (SAR) studies and new drug candidate synthesis.
• Impurity Profiling: Employed as a certified reference material to identify and quantify related substances in finished drug products.
• Academic Research: Used in university and institutional research projects focused on cardiovascular and metabolic diseases.
• Regulatory Submissions: Provides essential data and materials for regulatory filings (e.g., with FDA, EMA) requiring detailed impurity identification.

Basic Information

Product Name	2-Hydroxypropyl Nortadalafil
CAS No.	1353020-85-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Nortadalafil Hydroxypropyl Derivative; 2-HP Nortadalafil; Nortadalafil Impurity; Nortadalafil Related Compound; PDE5 Inhibitor Intermediate; Tadalafil Metabolite Analog; (6R,12aR)-2,3,6,7,12,12a-Hexahydro-2-methyl-6-(3-hydroxypropyl)pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione
EINECS	Contact for details

Quality Control

Our 2-Hydroxypropyl Nortadalafil is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing all specified parameters. Our quality commitment aligns with cGMP principles for pharmaceutical intermediates, ensuring reliability for your critical R&D and manufacturing processes.

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 under inert conditions or in a desiccator to prevent degradation. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
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
Water Content (KF)	≤ 1.0%
Heavy Metals	≤ 20 ppm

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