Description

Tadalafil Impurity 33 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 during its development and manufacturing. It is an essential tool for pharmaceutical R&D laboratories and quality assurance departments engaged in method validation, stability studies, and regulatory compliance. The product is supplied as a high-purity material to meet the stringent demands of the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard for the identification and quantification of Tadalafil Impurity 33 in API batches.
• Method Development and Validation in analytical laboratories for HPLC, UPLC, and LC-MS techniques.
• Stability-Indicating Studies to monitor impurity profiles in Tadalafil drug products under various storage conditions.
• Quality Control and Release Testing of Tadalafil API to ensure compliance with pharmacopeial monographs (e.g., USP, EP).
• Regulatory Submission Support, providing characterized impurity samples for drug master files (DMFs) and new drug applications (NDAs).
• Research and Development of Tadalafil generics and related pharmaceutical formulations.

Basic Information

Product Name	Tadalafil Impurity 33
CAS No.	1598416-03-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tadalafil Related Compound 33; Tadalafil EP Impurity J; Tadalafil USP Impurity; (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 Impurity; Tadalafil Process Impurity; PDE5 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Tadalafil Impurity 33 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic and spectroscopic methods to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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