Description

Tadalafil Impurity 13 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Tadalafil. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality assurance. The precise characterization and control of this impurity are essential for meeting stringent global pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material for the identification and quantification of Tadalafil Impurity 13 in API and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish system suitability, specificity, and detection limits.
• Quality Control & Batch Release Testing: Essential for routine impurity profiling to ensure Tadalafil API batches comply with ICH Q3A/B guidelines and regulatory specifications.
• Stability Studies: Employed to monitor the formation of this impurity under various stress conditions (e.g., heat, light, humidity) to determine drug product shelf-life.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) filings to health authorities like the FDA and EMA.
• Research & Development: Used in process chemistry to understand and minimize the formation of this impurity during the synthesis of Tadalafil.

Basic Information

Product Name	Tadalafil Impurity 13
CAS No.	1370438-57-5
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 Process Impurity; Tadalafil Degradant; Tadalafil EP Impurity; Tadalafil USP Impurity; Tadalafil API Impurity
EINECS	Contact for details

Quality Control

Every batch of Tadalafil Impurity 13 is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents in accordance with ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with specified 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 nature, the container should be kept in a desiccated environment to prevent moisture absorption, which could affect 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
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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