Description

Tadalafil Impurity 38 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 the final drug product by serving as a benchmark for impurity identification and quantification. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Tadalafil Impurity 38 in API and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate stability-indicating HPLC/UPLC methods for Tadalafil and related substances.
• Quality Control & Batch Release Testing: Employed in routine QC laboratories to monitor impurity profiles and ensure batch-to-batch consistency of Tadalafil API.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing impurity characterization data required by ICH, FDA, and EMA guidelines.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Tadalafil.
• Research & Development: Facilitates process chemistry research to understand and minimize the formation of this impurity during API synthesis.

Basic Information

Product Name	Tadalafil Impurity 38
CAS No.	185750-07-6
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 38; Tadalafil EP Impurity G; Tadalafil USP Impurity; Tadalafil Degradant; Tadalafil Process Impurity; (6R-trans)-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
EINECS	Contact for details

Quality Control

Every batch of Tadalafil Impurity 38 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

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 low-humidity environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
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	≤ 0.2%

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