Description

Tadalafil Impurity 34 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the analytical characterization and quality control of Tadalafil, a widely prescribed active pharmaceutical ingredient (API). It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure product safety and compliance with stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Tadalafil API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing necessary impurity profiles and stability data to agencies like the FDA and EMA.
• Stability Studies: Used to monitor the formation and behavior of this specific impurity during forced degradation and long-term stability testing of Tadalafil products.
• Process Chemistry & Impurity Profiling: Aids in the optimization of Tadalafil synthesis by identifying and tracking process-related impurities.
• Quality Assurance/Quality Control (QA/QC): Employed as a system suitability and system precision standard in routine batch release testing.

Basic Information

Item	Detail
Product Name	Tadalafil Impurity 34
CAS No.	2058231-15-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tadalafil Related Compound 34; Tadalafil Impurity RRT 0.9; (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 EP Impurity G; Tadalafil USP Impurity; Cialis Impurity 34; PDE5 Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Tadalafil Impurity 34 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and chromatographic testing to ensure compliance with pharmacopeial standards such as USP and EP. A comprehensive Certificate of Analysis (COA) detailing purity (by HPLC), identity confirmation (by IR/LC-MS), and impurity profile is provided with each shipment to guarantee traceability and reliability for your critical applications.

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 must be kept under dry, inert conditions to maintain stability and purity. Avoid repeated or prolonged exposure to the atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches 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 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.