Leachables And Extractables Handbook Pdf

leachables and extractables handbook pdf

File Name: leachables and extractables handbook .zip
Size: 12571Kb
Published: 16.06.2021

By Wiley. A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products.

Extractables and Leachables Testing for Inhaled Medicines

No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, scanning, or otherwise, except as permitted under Section or of the United States Copyright Act, without either the prior written permission of the Publisher, or authorization through payment of the appropriate per-copy fee to the Copyright Clearance Center, Inc. No warranty may be created or extended by sales representatives or written sales materials. The advice and strategies contained herein may not be suitable for your situation. You should consult with a professional where appropriate. Neither the publisher nor author shall be liable for any loss of profi t or any other commercial damages, including but not limited to special, incidental, consequential, or other damages. For general information on our other products and services or for technical support, please contact our Customer Care Department within the United States at , outside the United States at or fax

Leachables and Extractables Handbook (eBook)

Orally inhaled and nasal drug product OINDP formulations, which are primarily a propellant including an organic solvent, have a high potential for the leaching of substances from the delivery device components. In this context, a device such as a dry powder inhaler DPI or pressurized metered dose inhaler pMDI is considered a primary packaging material or a container closure system CCS. Extractables are compounds that are released from a CCS into an extraction solution, which is typically a simulation solvent that mimics the drug formulation, during forced extraction experiments. Leachables are compounds that leach from a CCS into the drug formulation under normal storage conditions, such as those applied during a formal stability study. Extractables are common, but not always the worst-case leachables; new reaction products formed from extractables and drug formulation components can also be considered as extractables. Leachables are drug product impurities that have the potential to affect patient safety. For example, in a pMDI, precipitates were identified that were found to be polyaromatic hydrocarbons PAHs , mercapto-benzothiazol, and N-nitrosamines originating from the rubber materials used for construction of the inhaler devices 1, 2.

Add the following:. This section addresses specific considerations for leachables in orally inhaled and nasal drug products OINDP , including metered dose inhalers MDIs ; nasal sprays; inhalation solutions, suspensions, and sprays; and dry powder inhalers DPIs. Although OINDP can be a combination of products that are comprised of drug and device constituent parts, the primary mode of action is typically through the drug. Note that the following discussion is primarily devoted to organic leachables. For consideration of inorganic i. In addition to the key terms listed in , some additional key terms more specific to OINDP are the following:.

Leachables and Extractables Handbook (eBook, PDF)

Skip to search form Skip to main content You are currently offline. Some features of the site may not work correctly. Norwood and L. Nagao and C. Norwood , L.

Du kanske gillar. Ladda ned. Spara som favorit.

Douglas J. Ball , Daniel L. Norwood , Cheryl L. Stults , Lee M.

Он знал, что это трюк. Корпорация Нуматек сделала очень крупную ставку на новый алгоритм Танкадо, и теперь кто-то из конкурентов пытается выведать ее величину. - У вас есть ключ? - сказал Нуматака с деланным интересом. - Да. Меня зовут Северная Дакота.

 Con permiso! - крикнул санитар. Мимо стремительно проплыла каталка. Беккер успел отскочить в сторону и окликнул санитара.

1 COMMENTS

Earrettiopa

REPLY

Handbook of self and identity second edition pdf potential and kinetic energy quiz pdf

LEAVE A COMMENT