Dabigatran Impurity 10

About Dabigatran Impurity 10

Dabigatran Impurity 10 is an impurity of Dabigatran carrying the CAS registry number 211916-39-1 at a purity of 99%. Formula C26H24N6O3, molecular weight 468.5 g/mol. The IUPAC name is methyl 3-[[2-[(4-cyanoanilino)methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoate. It is also known as DBT-5-II Impurity or Dabigatran Impurity 16.

The product is provided as a solid. Keep the vial tightly closed, protected from light and humidity, at the temperature stated on the Certificate of Analysis. Good laboratory practice and suitable PPE are recommended during handling.

Pharmaceutical QC and development laboratories use this impurity standard of Dabigatran to develop and validate HPLC methods, to set specification limits and to document impurity profiles in ANDA and DMF submissions. Typical end-use sectors are 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. This item is currently in stock for prompt dispatch.

Typical applications

Analytical method development
Method validation (AMV)
QC release testing
ANDA / DMF filings

Industries

Related to Dabigatran

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

Dabigatran impurities

Specifications & identifiers

Chemical identifiers
Product name	Dabigatran Impurity 10
Catalogue No.	VQ-004695
CAS Number	211916-39-1
IUPAC name	methyl 3-[[2-[(4-cyanoanilino)methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoate
Molecular formula	C₂₆H₂₄N₆O₃
Molecular weight	468.5 g/mol
Exact mass	468.191
Grade	Reference Standard
Purity / assay	99%
HSN code	38229090
InChIKey	NHLNCKBZUVTVHK-UHFFFAOYSA-N
SMILES	CN1C2=C(C=C(C=C2)C(=O)N(CCC(=O)OC)C3=CC=CC=N3)N=C1CNC4=CC=C(C=C4)C#N
PubChem CID	18412352

Physical properties
Physical form	Solid
LogP (XLogP3)	2.8
H-bond donors / acceptors	1 / 7
TPSA	113 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 Dabigatran Impurity 10?

The CAS Registry Number of Dabigatran Impurity 10 is 211916-39-1. It is also known as DBT-5-II Impurity, Dabigatran Impurity 16, Dabigatran Impurity 44.

What is the molecular formula and molecular weight of Dabigatran Impurity 10?

Dabigatran Impurity 10 has the molecular formula C26H24N6O3 and a molecular weight of 468.5 g/mol. Its IUPAC name is methyl 3-[[2-[(4-cyanoanilino)methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoate.

What is Dabigatran Impurity 10 used for?

Dabigatran Impurity 10 is supplied as a characterised reference material related to Dabigatran. 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 Dabigatran Impurity 10 can I order?

We supply Dabigatran Impurity 10 in Reference Standard (99%) grade, in 10 mg, 25 mg, 50 mg, 100 mg, 250 mg packs. Larger bulk quantities and custom packing are quoted on request.

Do you provide a COA and SDS with Dabigatran Impurity 10?

Yes. Every lot of Dabigatran Impurity 10 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 Dabigatran Impurity 10 be shipped internationally?

Yes. We export Dabigatran Impurity 10 worldwide by air and sea freight or express courier, on EXW, FOB, CIF, CFR or DAP Incoterms, with full export documentation.