Tadalafil EP Impurity H

About Tadalafil EP Impurity H

Tadalafil EP Impurity H is a pharmacopeial impurity of Tadalafil carrying the CAS registry number 1978322-98-3. With the molecular formula C22H19N3O6, it has a molar mass of 421.4 g/mol. Alternative names: Tadalafil - Impurity H and Tadalafil Ketolactam.

It is supplied as a solid. Store the standard in its sealed vial, protected from light and moisture, and follow the storage condition printed on the COA. Handle it with standard laboratory precautions and appropriate personal protective equipment.

This Tadalafil impurity supports analytical method development and validation (AMV), batch release testing and the impurity sections of ANDA and DMF filings. It is used across pharmaceutical manufacturing and academic and industrial research.

Standard pack sizes are 10 mg, 25 mg, 50 mg and 100 mg, and every batch ships with a Certificate of Analysis (COA) and we export worldwide.

Typical applications

Pharmacopeial method verification
Impurity profiling
QC release testing
ANDA / DMF filings

Industries

Related to Tadalafil

View every impurity, metabolite and intermediate we list for Tadalafil.

Tadalafil impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Tadalafil EP Impurity H
Catalogue No.	VQ-034899
CAS Number	1978322-98-3
IUPAC name	(6R,14aR)-6-(1,3-benzodioxol-5-yl)-2-methyl-6,8,14,14a-tetrahydro-3H-pyrazino[1,2-d][1,4]benzodiazonine-1,4,7,13-tetrone
Molecular formula	C₂₂H₁₉N₃O₆
Molecular weight	421.4 g/mol
Exact mass	421.1274
Grade	Reference Standard
HSN code	38229090
InChIKey	BBMXALYUYHSADD-FOIQADDNSA-N
SMILES	CN1CC(=O)N2[C@@H](C1=O)CC(=O)C3=CC=CC=C3NC(=O)[C@H]2C4=CC5=C(C=C4)OCO5
PubChem CID	71752283

Physical properties
Physical form	Solid
LogP (XLogP3)	1
H-bond donors / acceptors	1 / 6
TPSA	105 Å²

Documents

Safety Data Sheet (SDS)16-section GHS · on request Certificate of AnalysisTypical / batch COA · on request Specification sheetTDS / MOA · on request

Frequently asked questions

What is the CAS number of Tadalafil EP Impurity H?

The CAS Registry Number of Tadalafil EP Impurity H is 1978322-98-3. It is also known as Tadalafil - Impurity H, Tadalafil Ketolactam, Tadalafil Ketolactam (>90per cent).

What is the molecular formula and molecular weight of Tadalafil EP Impurity H?

Tadalafil EP Impurity H has the molecular formula C22H19N3O6 and a molecular weight of 421.4 g/mol. Its IUPAC name is (6R,14aR)-6-(1,3-benzodioxol-5-yl)-2-methyl-6,8,14,14a-tetrahydro-3H-pyrazino[1,2-d][1,4]benzodiazonine-1,4,7,13-tetrone.

What is Tadalafil EP Impurity H used for?

Tadalafil EP Impurity H is supplied as a characterised reference material related to Tadalafil. It is used for analytical method development and validation (AMV), impurity profiling, stability studies and quality control, and in ANDA/DMF regulatory filings.

Which grade and pack sizes of Tadalafil EP Impurity H can I order?

We supply Tadalafil EP Impurity H in Reference Standard grade, in 10 mg, 25 mg, 50 mg, 100 mg packs. Larger bulk quantities and custom packing are quoted on request.

Do you provide a COA and SDS with Tadalafil EP Impurity H?

Yes. Every lot of Tadalafil EP Impurity H is shipped with a batch-specific Certificate of Analysis, and a 16-section GHS Safety Data Sheet is provided with the quotation and the shipment.

Can Tadalafil EP Impurity H be shipped internationally?

Yes. We export Tadalafil EP Impurity H worldwide by air and sea freight or express courier, on EXW, FOB, CIF, CFR or DAP Incoterms, with full export documentation.