Description

Taladafil Impurity CAS NO 1356345-67-9 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development. This compound is critical for ensuring the safety and efficacy of active pharmaceutical ingredients (APIs) by accurately identifying and quantifying related substances. It is primarily required by research institutions, analytical laboratories, and pharmaceutical manufacturers involved in the synthesis and quality assurance of tadalafil and related compounds.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of specific impurities in tadalafil API and finished drug products.
• Analytical Method Development & Validation: Used to develop, calibrate, and validate High-Performance Liquid Chromatography (HPLC) and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in GMP environments to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed as a marker compound in forced degradation and long-term stability studies of tadalafil formulations.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Process Chemistry Research: Used by chemists to study and optimize synthetic pathways, helping to minimize the formation of this specific impurity during manufacturing.

Basic Information

Product Name	Taladafil Impurity
CAS No.	1356345-67-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tadalafil Related Compound; Tadalafil Impurity Standard; Tadalafil Specified Impurity; (6R,12aR)-2,3,6,7,12,12a-Hexahydro-2-methyl-6-(3,4-methylenedioxyphenyl)pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione Impurity; PDE5 Inhibitor Impurity; Cialis Impurity; Adcirca Impurity
EINECS	Contact for details

Quality Control

Our Taladafil Impurity is manufactured under strict quality systems to meet the exacting standards of pharmaceutical analysis. Each batch undergoes rigorous testing, including identity confirmation by spectroscopic methods (IR, NMR, MS) and purity determination by advanced chromatographic techniques (HPLC, GC). A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing the analytical results, test methods, and traceability. Our quality commitment aligns with cGMP principles and supports compliance with ICH, USP, and EP guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (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%

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