Dabigatran Impurity 8

Name: Dabigatran Impurity 8
Brand: Vaqora Chemicals
SKU: VQ-004701

About Dabigatran Impurity 8

Vaqora Chemicals supplies Dabigatran Impurity 8, an impurity of Dabigatran registered under CAS number 429659-01-8. The compound has the formula C18H20N4O5, corresponding to a molecular weight of 372.4 g/mol. Systematically, it is named ethyl 3-[[4-(methylamino)-3-nitrobenzoyl]-pyridin-2-ylamino]propanoate. It is also known as Dabigatran Impurity 14 or Dabigatran Impurity 67.

The product is provided 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.

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. Our customers for this product work in pharmaceutical manufacturing and academic and industrial research.

Available in 10 mg, 25 mg, 50 mg and 100 mg packs, Dabigatran Impurity 8 is dispatched with a Certificate of Analysis (COA) to destinations worldwide. Stock is available for quick 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 8
Catalogue No.	VQ-004701
CAS Number	429659-01-8
Other CAS	1187067-68-0, 1354793-01-3, 1423073-48-6
IUPAC name	ethyl 3-[[4-(methylamino)-3-nitrobenzoyl]-pyridin-2-ylamino]propanoate
Molecular formula	C₁₈H₂₀N₄O₅
Molecular weight	372.4 g/mol
Exact mass	372.1434
Grade	Reference Standard
HSN code	38229090
InChIKey	FYSFQBXGCDIVMA-UHFFFAOYSA-N
SMILES	CCOC(=O)CCN(C1=CC=CC=N1)C(=O)C2=CC(=C(C=C2)NC)[N+](=O)[O-]
PubChem CID	11079230

Physical properties
Physical form	Solid
LogP (XLogP3)	2.8
H-bond donors / acceptors	1 / 7
TPSA	117 Å²
Synonyms	N-[4-(Methylamino)-3-nitrobenzoyl]-N-2-pyridinyl-β-alanine ethyl ester, Ethyl 3-[[4-(methylamino)-3-nitrobenzoyl](pyridin-2-yl)amino]propanoate, Ethyl 3-(4-(methylamino)-3-nitro-N-(pyridin-2-yl)benzamido)propanoate, N-[4-(Methylamino)-3-nitrobenzoyl]-N-2-pyridinyl-beta-alanine ethyl ester, N-(4-(Methylamino)-3-nitrobenzoyl)-N-2-pyridinyl-beta-alanine ethyl ester, Dabigatran Impurity 14, ethyl3-(4-(methylamino)-3-nitro-N-(pyridin-2-yl)benzamido)propanoate, Dabigatran Impurity 67, Ethyl 3-[[4-(Methylamino)-3-nitrobenzoyl]-(2-pyridyl)amino]propanoate, Dabigatran Etexilate Impurity 88, CS-M2455, ethyl 3-[[4-(methylamino)-3-nitro-benzoyl]-(2-pyridyl)amino]propanoate

Safety & hazard information (GHS)

Hazard statements

H412Harmful to aquatic life with long lasting effects

Precautionary statements: P273, P501

Classification is indicative (aggregated GHS notifications) and may vary by grade and concentration. Always refer to the SDS supplied with your lot.

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 8?

The CAS Registry Number of Dabigatran Impurity 8 is 429659-01-8. It is also known as N-[4-(Methylamino)-3-nitrobenzoyl]-N-2-pyridinyl-β-alanine ethyl ester, Ethyl 3-[[4-(methylamino)-3-nitrobenzoyl](pyridin-2-yl)amino]propanoate, Ethyl 3-(4-(methylamino)-3-nitro-N-(pyridin-2-yl)benzamido)propanoate.

What is the molecular formula and molecular weight of Dabigatran Impurity 8?

Dabigatran Impurity 8 has the molecular formula C18H20N4O5 and a molecular weight of 372.4 g/mol. Its IUPAC name is ethyl 3-[[4-(methylamino)-3-nitrobenzoyl]-pyridin-2-ylamino]propanoate.

What is Dabigatran Impurity 8 used for?

Dabigatran Impurity 8 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 8 can I order?

We supply Dabigatran Impurity 8 in Reference Standard grade, in 10 mg, 25 mg, 50 mg, 100 mg, 250 mg, 500 mg packs. Larger bulk quantities and custom packing are quoted on request.

Do you provide a COA and SDS with Dabigatran Impurity 8?

Yes. Every lot of Dabigatran Impurity 8 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 8 be shipped internationally?

Yes. We export Dabigatran Impurity 8 worldwide by air and sea freight or express courier, on EXW, FOB, CIF, CFR or DAP Incoterms, with full export documentation.