Results 11 to 20 of about 1,329 (193)

Introduction of General Chapters on standard methods for allergen quantification in the European Pharmacopoeia

Allergy, Volume 78, Issue 4, Page 923-927, April 2023., 2023
Abstract The Biological Standardization Project BSP090 has been successfully concluded in 2021. As a result, two standard methods for quantification of the major allergens Bet v 1 and Phl p 5 will be implemented in the European Pharmacopoeia (Ph. Eur.).
Julia Zimmer, Andreas Bonertz, Susanne Kaul, Stefan Vieths   +3 more
wiley   +1 more source

Safety and Efficacy of Medicinal Plants Used to Manufacture Herbal Products with Regulatory Approval in Uganda: A Cross‐Sectional Study

Evidence-Based Complementary and Alternative Medicine, Volume 2022, Issue 1, 2022., 2022
Introduction. The Uganda National Drug Authority requires phytochemical screening, freedom from microbial contamination, and evidence of safety and efficacy of the constituent plants to register herbal products. Since Uganda has no pharmacopeia, safety, efficacy, and plant processing information are not readily available.
Bruhan Kaggwa, Henry Kyeyune, Edson Ireeta Munanura, Godwin Anywar, Stephen Lutoti, Jacqueline Aber, Lynn K. Bagoloire, Anke Weisheit, Casim Umba Tolo, Pakoyo Fadhiru Kamba, Patrick Engeu Ogwang, Mohammed Bourhia   +11 more
wiley   +1 more source

Discrepancies in the German Pharmacopoeia procedure for quality control of Quillaja saponin extracts

Archiv der Pharmazie, Volume 354, Issue 12, December 2021., 2021
This study revealed a mistake in the German Pharmacopoeia ninth edition for a saponin reagent. Quillaja saponin extracts labeled DAB (Deutsches Arzneibuch) were found to be adulterated with Madhuca saponins using high‐performance liquid chromatography and mass spectrometry (HPLC–MS). This adulteration has gone unnoticed so far because the existing test
Bernhard Thalhamer, Wolfgang Buchberger
wiley   +1 more source

Enantioseparation of solriamfetol and its major impurity phenylalaninol by capillary electrophoresis using sulfated gamma cyclodextrin

ELECTROPHORESIS, Volume 42, Issue 17-18, Page 1818-1825, September 2021., 2021
Abstract R‐solriamfetol is a recently approved drug used for the treatment of excessive sleepiness associated with narcolepsy and sleep apnea. Herein, a capillary electrophoretic method was developed, enabling the simultaneous analysis of the API and its S‐enantiomer in addition to the enantiomers of its major impurity phenylalaninol.
Ida Fejős, Gergő Tóth, Bianka Várnai, Zoltán István Szabó, István Köteles, Milo Malanga, Szabolcs Béni   +6 more
wiley   +1 more source

The Use of Phospholipids to Make Pharmaceutical Form Line Extensions

European Journal of Lipid Science and Technology, Volume 123, Issue 4, April 2021., 2021
Review on the use of phospholipid excipients to make Pharmaceutical Form (Dosage Form) Line Extensions of existing drugs as part of a Product Life Cycle Management. Abstract This review describes the use of phospholipid excipients to make Pharmaceutical Form (Dosage Form) Line Extensions of existing drugs as part of a Product Life Cycle Management ...
Peter van Hoogevest, Harry Tiemessen, Josbert M. Metselaar, Simon Drescher, Alfred Fahr   +4 more
wiley   +1 more source

Development of an updated assay for prekallikrein activator in albumin and immunoglobulin therapeutics

Vox Sanguinis, Volume 116, Issue 1, Page 99-105, January 2021., 2021
Background Prekallikrein activator (PKA) is a contaminating enzyme found in therapeutic albumin and immunoglobulin products. The level is commonly measured using methods such as that defined by the European Pharmacopoeia (Ph Eur) with traceability to the WHO International Standard for PKA.
Graham Roberts, Bernard Fox, Colin Longstaff   +2 more
wiley   +1 more source

Anti‐Inflammatory Activity and Quality Control of Erysimum cheiri (L.) Crantz

BioMed Research International, Volume 2021, Issue 1, 2021., 2021
Wallflower (Erysimum cheiri) is employed as a popular herbal drug in traditional Persian medicine. Topical formulations including cerates, lotions, sitz baths, and poultices for inflammatory disorders such as arthritis, anal fissure, endometriosis, and mastitis are known.
Ghazaleh Mosleh, Amir Azadi, Sedigheh Khademian, Reza Heidari, Abdolali Mohagheghzadeh, Kazim Husain   +5 more
wiley   +1 more source

Adulteration and Poor Quality of Ginkgo biloba Supplements [PDF]

, 2016
Adulteration of Ginkgo products sold as unregistered supplements within the very large market of Ginkgo products (reputedly £650 million annually) through the post-extraction addition of cheaper (e.g.
Booker, A, Frommenwiler, D, Heinrich, M, Horsfield, S, Reich, E   +4 more
core   +4 more sources

Characteristic aspects of marketing authorisation and quality assurance of bacteriophage medicinal products in the Russian Federation

Биопрепараты: Профилактика, диагностика, лечение, 2023
The development and introduction of new bacteriophage-based medicinal products for human use is an important mission aimed at curbing the spread of infectious diseases caused by multi-resistant pathogens. The current global practice offers two approaches
D. S. Davydov, R. L. Parfenyuk, Z. V. Durmanova, V. A. Merkulov, A. A. Movsesyants   +4 more
doaj   +1 more source

In Vitro Comparative Quality Assessment of Different Brands of Doxycycline Hyclate Finished Dosage Forms: Capsule and Tablet in Jimma Town, South‐West Ethiopia

Advances in Pharmacological and Pharmaceutical Sciences, Volume 2021, Issue 1, 2021., 2021
Background. Persistent postmarket quality evaluation helps produce clear information on the current quality status of the different brands of a given drug and hence introduces a biopharmaceutical and therapeutically equivalent list of the products to the prescribers and users of it. This in turn facilitates access to essential medicines by breaking the
Woldemichael Abraham, Habtamu Abuye, Selass Kebede, Sultan Suleman, Tamer E. Youssef   +4 more
wiley   +1 more source