Description

Tadalafil Ep Impurity H is a high-purity reference standard used in the pharmaceutical development and quality control of Tadalafil, a key active pharmaceutical ingredient (API). This compound is critical for ensuring the safety, efficacy, and regulatory compliance of finished drug products by serving as a benchmark for impurity identification and quantification. It is an essential material for analytical laboratories, research institutions, and manufacturers engaged in the synthesis and validation of Tadalafil and related pharmaceutical formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Tadalafil Ep Impurity H in API and finished drug products.
• Analytical Method Development & Validation: Critical for developing, calibrating, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing necessary impurity profiles and stability data.
• Process Chemistry Research: Used in research to study the formation pathways and control strategies for this specific impurity during Tadalafil synthesis.
• Quality Assurance/Quality Control (QA/QC): Employed in routine batch release testing to monitor impurity levels against established pharmacopeial limits (e.g., EP, USP).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies of Tadalafil drug substances and products.

Basic Information

Product Name	Tadalafil Ep Impurity H
CAS No.	1978322-98-3
Molecular Formula	C₂₂H₁₉N₃O₄
Molecular Weight	389.41 g/mol
Synonyms	(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; Tadalafil Impurity H; Tadalafil Related Compound H; Tadalafil EP Impurity H; Tadalafil USP Impurity H; Tadalafil Process Impurity H
EINECS	Contact for details

Quality Control

Every batch of Tadalafil Ep Impurity H is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing, including advanced chromatographic techniques, to ensure it meets the high-purity standards required for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment to support your regulatory and quality requirements.

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); the container must be kept tightly sealed in a dry environment to prevent degradation.

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)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.