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API Impurities

Dabigatran Impurity 8

Reference StandardIn stock

Dabigatran Impurity 8 (CAS 429659-01-8) supplier Zemixal. Lab and bulk packs, batch COA, fast global delivery. Ships from India to 120+ countries.

Pack sizes
Dabigatran Impurity 8 chemical structure
CAS number429659-01-8
FormulaC18H20N4O5
Molar mass372.4 g/mol
Physical formSolid
HS code38229090
InChIKeyFYSFQBXGCDIVMA-UHFFFAOYSA-N
IUPAC nameethyl 3-[[4-(methylamino)-3-nitrobenzoyl]-pyridin-2-ylamino]propanoate

About Dabigatran Impurity 8

Dabigatran Impurity 8 belongs to the Dabigatran reference-standard family in the Zemixal catalogue. Key data (Reference Standard): CAS 429659-01-8, formula C18H20N4O5 and molar mass 372.4 g/mol. It is handled as a solid.

Where it is used

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

Standard pack sizes are 10 mg, 25 mg, 50 mg, 100 mg and 250 mg, and custom quantities are quoted on request. Every shipment includes a certificate of analysis with characterisation data. Send an enquiry through the quote panel and you get a formal offer with Incoterms and delivery time.

Reference standards for Dabigatran

See every impurity, metabolite and related compound we list for this API.

Dabigatran standards

Typical uses

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

Applications

Specifications and identifiers

Specifications of Dabigatran Impurity 8
Product nameDabigatran Impurity 8
Catalogue numberZX-004564
CAS number429659-01-8
Other CAS numbers1187067-68-0, 1354793-01-3, 1423073-48-6
IUPAC nameethyl 3-[[4-(methylamino)-3-nitrobenzoyl]-pyridin-2-ylamino]propanoate
Molecular formulaC18H20N4O5
Molar mass372.4 g/mol
Exact mass372.1434
GradeReference Standard
Physical formSolid
XLogP32.8
H-bond donors / acceptors1 / 7
Topological polar surface area117 Ų
HS code38229090
InChIKeyFYSFQBXGCDIVMA-UHFFFAOYSA-N
SMILESCCOC(=O)CCN(C1=CC=CC=N1)C(=O)C2=CC(=C(C=C2)NC)[N+](=O)[O-]
PubChem CID11079230
SynonymsN-[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

Lot values are stated on the batch certificate of analysis. Ask for a typical COA with your quotation.

Safety and GHS hazards

  • H412Harmful to aquatic life with long lasting effects

Precautionary statements P273, P501

Classification summarised from public GHS notifications. It can vary with grade and concentration, so always follow the SDS supplied with your lot.

Pack sizes

Pack sizes of Dabigatran Impurity 8
10 mgQuoted on request
25 mgQuoted on request
50 mgQuoted on request
100 mgQuoted on request
250 mgQuoted on request
500 mgQuoted on request
1 gQuoted on request

Need a different size? Bulk drums and custom packing are quoted on request through the quote form on this page.

Questions about Dabigatran Impurity 8

Which CAS number identifies Dabigatran Impurity 8?
Dabigatran Impurity 8 is registered under CAS 429659-01-8. You may also see it listed 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. Our catalogue number for this item is ZX-004564.
What are the formula and molar mass of Dabigatran Impurity 8?
For Dabigatran Impurity 8, its formula is C18H20N4O5 and its molar mass is 372.4 g/mol. The systematic (IUPAC) name is ethyl 3-[[4-(methylamino)-3-nitrobenzoyl]-pyridin-2-ylamino]propanoate. InChIKey FYSFQBXGCDIVMA-UHFFFAOYSA-N lets you match it in any structure database.
How is Dabigatran Impurity 8 used in pharmaceutical QC?
Dabigatran Impurity 8 is a characterised reference material linked to Dabigatran. Laboratories use it to identify and quantify this impurity during method development and validation, stability work, batch release testing and regulatory submissions.
What grade and pack sizes are available for Dabigatran Impurity 8?
This listing is Reference Standard grade. Standard packs are 10 mg, 25 mg, 50 mg, 100 mg, 250 mg, 500 mg. Larger quantities and custom packing can be quoted on request.
Which documents come with Dabigatran Impurity 8?
Each lot ships with a batch certificate of analysis and a 16-section GHS safety data sheet. A typical COA or specification sheet can be shared with the quotation before you order.
Can Zemixal ship Dabigatran Impurity 8 to my country?
Yes. Dabigatran Impurity 8 ships worldwide by express courier, air cargo or sea freight, quoted on the Incoterm you prefer, with full export documents.

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