Description

Tadalafil Impurity 12 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Tadalafil. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Tadalafil API and finished dosage forms.
• Analytical Method Development and Validation (HPLC, LC-MS) to establish specificity, accuracy, and detection limits.
• Quality Control and Assurance in GMP manufacturing environments to monitor batch-to-batch consistency.
• Stability Studies to track impurity profiles in drug products under various storage conditions.
• Regulatory Documentation and Submission to agencies like the US FDA and EMA.
• Research and Development for studying the degradation pathways and chemistry of Tadalafil.

Basic Information

Product Name	Tadalafil Impurity 12
CAS No.	154030-29-2
Molecular Formula	C₂₂H₁₉N₃O₄
Molecular Weight	389.41 g/mol
Synonyms	(6R,12aR)-6-(1,3-Benzodioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione; Tadalafil Related Compound; Tadalafil EP Impurity; Tadalafil USP Impurity; Tadalafil Degradant; Tadalafil Process Impurity; (6R-trans)-6-(1,3-Benzodioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione
EINECS	Contact for details

Quality Control

Our Tadalafil Impurity 12 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the stringent requirements for pharmaceutical reference standards. Each batch is characterized and tested for identity, purity, and impurities using validated methods such as HPLC, NMR, and MS. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results and confirming compliance with relevant pharmacopeial standards (e.g., USP, EP).

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 material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
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 impurity ≤ 1.0%
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.