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Dabigatran Impurity 8
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Highly Characterized Analytical Standard

Impurity or related compound · Dabigatran family

Pharmaceutical analytical standard

Dabigatran Impurity 8

Synonyms: 2-[(4-Carbamimidoylanilino)methyl]-1-methyl-N-[3-oxo-3-(pyridin-2-ylamino)propyl]-N-pyridin-2-ylbenzimidazole-5-carboxamide

Cat. No.
P-D001-059
CAS
1422435-42-4
Alternative CAS
N/A
Formula
C30H29N9O2
Molecular weight
547.62 g/mol
Category
Impurity or related compound

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Characterisation level

* Mass balance is performed on every molecule. The only exceptions are cases where the chemistry of the molecule prevents it, for example oils and highly volatile substances, on which some of the required measurements cannot be made: in those cases the CoA states how the content was assigned.

Quantity
Talk to a specialist

We reply within 24 hours with a quote and availability. CoA and SDS with every lot.

Family: Dabigatran

An oral anticoagulant that directly inhibits thrombin, approved in Europe in 2008. It is given as a prodrug, dabigatran etexilate, which the body converts into the active form.

Did you know?It was the first of the new oral anticoagulants to get a specific antidote, idarucizumab, an antibody that neutralises it within minutes.

The two levels compared

Level 1
Mass balance
Level 2
Mass balance + qNMR
Identity (IR, MS, 1H and 13C-NMR; peptides: ESI-MS, MALDI-TOF and IR)✓✓
HPLC purity (min. 95%)✓✓
Content by mass balance (min. 90%; peptides: for information only)*✓✓
Content verified by qNMR (small molecules only)·✓
Suitable to qualify it as an in-house primary standard (ICH Q7)·✓

* Mass balance is performed on every molecule. The only exceptions are cases where the chemistry of the molecule prevents it, for example oils and highly volatile substances, on which some of the required measurements cannot be made: in those cases the CoA states how the content was assigned.

What you receive

The analytical standard

Shipped under controlled temperature when the molecule requires it.

Certificate of analysis (CoA)

For every lot: identity, purity and assay, with the supporting spectra and chromatograms.

Safety data sheet (SDS)

Sent with every order.

Tracked shipment

Follow your shipment live, from our warehouse to your lab.

More products in the Dabigatran family

DabigatranActive ingredientDabigatranCat. No. P-D001-001CAS 211914-51-1

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Frequently asked questions

Is mass balance always performed?

Yes, on every molecule. The only exceptions are cases where the chemistry of the molecule prevents it: for example oils and highly volatile substances, on which some measurements (such as thermogravimetry) cannot be made. In those cases the CoA states which method was used to assign the content.

Can I ask for a different quantity?

Yes. The quantities are only suggestions: choose "Other" and enter the milligrams or grams you need.

Which level should I choose?

Level 1 is enough for most routine testing. Level 2 adds an independent qNMR content value and is meant for labs that need to qualify an in-house primary standard. For peptides and similar molecules, Level 2 is not available.

When will I get the quote?

Within 24 working hours, with price, availability and delivery time.

Need a molecule you cannot find?

Custom synthesis of impurities, metabolites and labelled compounds, with the same characterisation level.