Moreover, while the Rabbit Pyrogen Test has a relatively high limit of detection (EU/ml) when compared to BETs on the market, the CTL-MAT Monocyte Activation Test kit in fact has the very lowest limit of detection (0.004 EU/ml) when compared to any other assay – whether LAL, rFC or Rabbit Pyrogen Test – on the market. Unlike the Rabbit Pyrogen Test, the CTL-MAT Monocyte Activation Test kit offered by MAT BioTech reflects the specifically human reaction to pyrogens and thus better predicts the pyrogenic activity in humans than the Rabbit Pyrogen Test does. For example, the Rabbit Pyrogen Test cannot be employed in detecting pyrogens in chemotherapeutics, immunosuppressive agents, nor can it be used to test human cellular preparations such as plasmas or stem cells. Further, the Rabbit Pyrogen Test (RPT) lacks a positive control, is widely considered to be unrobust as stress to rabbits has been found to influence results, and perhaps most saliently, the Rabbit Pyrogen Test is limited in the types of products it can effectively test. This primarily owes to the rabbit pyrogen test’s low sensitivity, non-human specificity and the solely qualitative results it can promise. The General Chapter on the Rabbit pyrogen test (2.6.8.) clearly states:īeyond a solely regulatory impetus to protect animal welfare, the phenomenon of organisations transitioning away from the Rabbit Pyrogen test (RPT) has already been steadily occurring since the early 2000’s. has committed to a five year plan to see the rabbit pyrogen test completely replaced. Having added the Monocyte-activation test (2.6.30.) general chapter in 2009, as of June 2021 the Ph. has mandated the transition towards in-vitro alternatives i n accordance with the 3Rs principles of Replacement, Reduction and Refinement of in-vivo testing. intrinsic pyrogenicity of product or where interfering factors between product and BET are insurmountable).įor over 100 years, the Rabbit Pyrogen Test (RPT) has been the gold standard test for pyrogens. where there is an established risk of non-endotoxin pyrogen contamination during the product's manufacturing process or where the product's very nature makes Bacterial Endotoxin testing (BET) unsuitable (e.g. A pyrogen test is often specifically favoured by Ph.
This means you can order the new chemical reference standards alongside the BP 2020 - helping you comply with the new standards from January 2020.Parenteral products are mandated by the European Pharmacopoeia to be free of either endotoxins or pyrogens more broadly. We're releasing 16 new BPCRS to coincide with the new and revised monographs in the BP 2020.
Archive subscribers can now identify all previous editions of BP and Ph. Easily see updates, withdrawals and omissions of monographs. Timeline functionality and cleaner design helps you find the information you need.
10.1 and 10.2 included as in-year online and download product updates. Helping you to comply with the BP, navigate more effectively and follow formulated product monographs. Eur.) monographs, making the BP a convenient and fully comprehensive set of standards that can be used across Europe and beyond. It includes around 4,000 monographs including the BP (Veterinary) and all European Pharmacopoeia (Ph. The British Pharmacopoeia (BP) 2020 is the most comprehensive collection of authoritative official standards for UK pharmaceutical substances and medicinal products. Kingdom pharmacopoeial standards for medicines for human.
Users of the British Pharmacopoeia thereby benefit byįinding within this comprehensively indexed compendium all current United Monographs of the 9th Edition of the European Pharmacopoeia, as amended by Volume, the British Pharmacopoeia (Veterinary) 2020, incorporates all the This edition, together with its companion Supported by its Groups of Experts and Working Parties, and- are reproducedįrom the European Pharmacopoeia. Have been elaborated or revised under the auspices of the British PharmacopoeiaĬommission whilst others (indicated to users by a chaplet of stars) have beenĮlaborated, or revised, under the auspices of the. Some of these monographs are of national origin and
Pharmacopoeia Commission, with the collaboration and support of its ExpertĪdvisory Groups, Panels of Experts and Working Parties and containsĪpproximately 4000 monographs for substances, preparations and articles used in Supersedes the British Pharmacopoeia 2019.