Human coagulation factor ix concentrate BRP, 30 mg

Human coagulation factor ix concentrate is a European Pharmacopoeia biological reference preparation, prescribed under Ph. Eur. monograph 20711, 2522. It is intended for identification, assay and purity testing under the official methods of the European Pharmacopoeia.

Identity is established by CAS number 9001-28-4, EDQM catalogue code H0920500, current batch 3.

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.

Packaging and storage

Supplied as 30 mg per vial. 3 vials per sales unit. Store frozen at −20 °C ± 5 °C. Ships at ambient temperature and must be moved to −20 °C on arrival.

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.