Dabigatran Impurity 95

About Dabigatran Impurity 95

Dabigatran Impurity 95 is an impurity of Dabigatran carrying the CAS registry number 1292616-09-1. Formula C10H14N2O2, molecular weight 194.23 g/mol.

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. 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.

Available in 10 mg, 25 mg, 50 mg and 100 mg packs, Dabigatran Impurity 95 is dispatched with a Certificate of Analysis (COA) to destinations worldwide.

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 95
Catalogue No.	VQ-036503
CAS Number	1292616-09-1
Molecular formula	C₁₀H₁₄N₂O₂
Molecular weight	194.23 g/mol
Grade	Reference Standard
HSN code	38229090

Physical properties
Physical form	Solid

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 95?

The CAS Registry Number of Dabigatran Impurity 95 is 1292616-09-1.

What is the molecular formula and molecular weight of Dabigatran Impurity 95?

Dabigatran Impurity 95 has the molecular formula C10H14N2O2 and a molecular weight of 194.23 g/mol.

What is Dabigatran Impurity 95 used for?

Dabigatran Impurity 95 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 95 can I order?

We supply Dabigatran Impurity 95 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 Dabigatran Impurity 95?

Yes. Every lot of Dabigatran Impurity 95 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 95 be shipped internationally?

Yes. We export Dabigatran Impurity 95 worldwide by air and sea freight or express courier, on EXW, FOB, CIF, CFR or DAP Incoterms, with full export documentation.