Dabigatran etexilate impurity A CRS, 12 mg

Dabigatran etexilate impurity A is a European Pharmacopoeia chemical reference substance, prescribed under Ph. Eur. monograph 3095. It is intended for identification and quantification of a specified impurity.

Identity is established by CAS number 1408238-40-3, EDQM catalogue code Y0002388, current batch 1.

Application

Reference standards of the European Pharmacopoeia are used in the tests and assays of the official Ph. Eur. methods, by analysts competent in those methods. Typical use is in pharmaceutical quality control — release and stability testing, method development and validation, and system suitability checks in chromatographic analysis. As an impurity standard, it supports the related-substances test for the corresponding monograph.

Packaging and storage

Supplied as 12 mg per vial. One vial per sales unit. Store refrigerated at +5 °C ± 3 °C. Ships at ambient temperature.

Notes

• For laboratory analytical use only. Not for human or veterinary consumption, and not for therapeutic, diagnostic or food use.
• Reference standards are non-returnable once dispatched, except where faulty, damaged or incorrectly supplied. Please report any damage within one working day of delivery, with photographs.