Description

Tadalafil Ep Impurity is a high-purity reference standard used in the analytical profiling and quality control of pharmaceutical active ingredients. This compound is critical for ensuring the safety and efficacy of drug products by enabling the accurate identification and quantification of process-related impurities. It is primarily utilized by pharmaceutical manufacturers, research laboratories, and quality control (QC) departments involved in the development and production of tadalafil-based medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for calibrating analytical instruments and validating testing methods.
• Impurity Profiling & Identification: Used in HPLC, LC-MS, and GC-MS analyses to identify and quantify the Ep impurity in tadalafil drug substance and finished dosage forms.
• Method Development & Validation: Essential for developing and validating stability-indicating assay methods as per ICH guidelines.
• Quality Control & Batch Release: Employed in routine QC testing to ensure tadalafil batches meet stringent purity specifications and regulatory limits for known impurities.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs).
• Stability Studies: Used to monitor the formation of degradation products under various stress conditions during drug stability testing.

Basic Information

Product Name	Tadalafil Ep Impurity
CAS No.	479545-76-1
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 EP; Tadalafil Related Compound EP; Tadalafil EP Isomer; Tadalafil Process Impurity; Tadalafil European Pharmacopoeia Impurity
EINECS	Contact for details

Quality Control

Our Tadalafil Ep Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods (IR, NMR, MS), to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

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 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 single 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.