Description

Tadalafil Impurity B is a designated pharmaceutical impurity used as a certified reference standard in analytical chemistry. 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, quality control laboratories, and regulatory bodies for method development, validation, and routine batch analysis. The use of a well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines from the USP, EP, and ICH.

Application

• Pharmaceutical Quality Control (QC): Used as a reference standard for the identification and quantification of Tadalafil Impurity B in Tadalafil API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods to monitor impurity profiles.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity data for drug master files and quality reviews.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Research & Development (R&D): Used in synthetic chemistry research to study the formation pathways and chemical behavior of Tadalafil-related impurities.
• Pharmacopeial Testing: Serves as a critical component for testing against specifications outlined in the United States Pharmacopeia (USP) and European Pharmacopoeia (EP) monographs for Tadalafil.

Basic Information

Product Name	Tadalafil Impurity B
CAS No.	951661-82-8
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 B; Tadalafil EP Impurity B; Tadalafil USP Impurity B; (6R,12aR)-2-Methyl-6-(3,4-methylenedioxyphenyl)-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

Every batch of Tadalafil Impurity B is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques including HPLC, NMR, and MS. We support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances and products.

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. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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