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General monographs and pharmacopoeial monographs of the State pharmacopoeia of Russian Federation XIII edition

Регуляторные исследования и экспертиза лекарственных средств, 2018
The State Pharmacopoeia of the Russian Federation is a collection of general monographs and pharmacopoeial monographs. It should be reissued at least once in 5 years.
V. A. Merkulov, E. I. Sakanyan, T. B. Shemeryankina, O. A. Mochikina, N. D. Bunyatyan   +4 more
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Ensuring the quality of medicines in India: An update on the development, modernization, and harmonization of drug standards in the Indian Pharmacopoeia [PDF]

Saudi Pharmaceutical Journal, 2023
India has a sparkling pharmaceutical sector that holds a distinguished place by producing and supplying high-quality and affordable medicines across the globe.
Gaurav Pratap Singh Jadaun, Shruti Rastogi, Amit Kumar, Jaishiv Chauhan, Surendra Kumar Sharma, Mukesh Kumar, Pawan Kumar Saini, Ritu Tiwari, Rajeev Singh Raghuvanshi   +8 more
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Sustainability in Analytical Chemistry Illustrated by Pharmaceutical Nitrosamine Testing. [PDF]

Electrophoresis
ABSTRACT Following the valsartan scandal in 2018, the testing of drug substances and drug products for N‐nitrosamines has become a critical and mandatory quality control measure. The European Pharmacopoeia chapter 2.5.42 currently describes three analytical methods for this purpose: HPLC–MS/MS, GC–MS, and GC–MS/MS.
Bredendiek F, Schmidtsdorff S, Parr MK.
europepmc   +2 more sources

Safety and efficacy of a feed additive consisting of l-histidine monohydrochloride monohydrate produced with <i>Escherichia coli</i>CCTCC M 20241089 for all animal species (Anhui Huaheng Biotechnology Co., Ltd). [PDF]

EFSA J
Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l‐histidine monohydrochloride monohydrate produced with a genetically modified strain of Escherichia coli (CCTCC M 20241089) as a nutritional additive in feed and water for drinking for all animal species and ...
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Villa RE, Azimonti G, Bonos E, Christensen H, Durjava M, Dusemund B, Gehring R, Glandorf B, Kouba M, López-Alonso M, Marcon F, Nebbia C, Pechová A, Prieto-Maradona M, Theodoridou K, Anguita M, Innocenti ML, Tarrés-Call J, Pettenati E.   +19 more
europepmc   +2 more sources

GENERAL MONOGRAPHS ON PROBIOTICS PREPARATIONS FOR STATE PHARMACOPOEIA OF THE RUSSIAN FEDERATION XIII EDITION – FIRST EXPERIENCE IN THE WORLD PHARMACOPOEIA PRACTICE [PDF]

International Journal of Applied and Fundamental Research (Международный журнал прикладных и фундаментальных исследований), 2016
Ирина Григорьевна Осипова, В.Ф. Евлашкина, Д. С. Давыдов, Елена Ивановна Саканян   +3 more
openaire   +2 more sources

Safety and efficacy of a feed additive consisting of narasin and diclazuril (Interban®) for chickens for fattening and chickens reared for laying (Elanco GmbH). [PDF]

EFSA J
Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the coccidiostat consisting of narasin and diclazuril (Interban®) for chickens for fattening and chickens reared for laying. The FEEDAP Panel concludes that the use of Streptomyces sp. NRRL B‐67771 in the production of
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Villa RE, Azimonti G, Bonos E, Christensen H, Durjava M, Dusemund B, Gehring R, Glandorf B, Kouba M, López-Alonso M, Marcon F, Nebbia C, Pechová A, Prieto-Maradona M, Theodoridou K, Bastos M, Bories G, Brantom P, Cocconcelli PS, Gropp J, Petkova M, Ramos F, Rychen G, Tosti L, Woutersen R, Galobart J, Manini P, Navarro-Villa A, Pettenati E, Pizzo F, Rossi B, Vettori MV, Holczknecht O.   +33 more
europepmc   +2 more sources

Calculation of the Median Lethal Dose and Low Lethal Dose Using the CombiStats Biometric Software

Регуляторные исследования и экспертиза лекарственных средств, 2021
The median lethal dose (LD50) and low lethal dose (LD10) are calculated in acute toxicity studies, as well as during specific activity assessment of some medicines.
P. V. Shadrin, T. A. Batuashvili, L. V. Simutenko, N. P. Neugodova   +3 more
doaj   +1 more source

Comparative analysis of carbomer polymers for pharmaceutical and cosmetic practice

Zaporožskij Medicinskij Žurnal, 2020
The aim of the study. Given the wide range of carbomers, their manufacturing technologies, solvent systems for their synthesis, differences in name and regulation, there is a need to systematize this group of excipients for the pharmaceutical and ...
H. P. Kukhtenko, T. V. Popova, Ie. V. Gladukh, O. S. Kukhtenko   +3 more
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Methodological Approaches to Determination of Depressor Substances in Medicinal Products

Регуляторные исследования и экспертиза лекарственных средств, 2020
In order to harmonise national and foreign requirements for quality control of medicinal products, a second variant of the test method, which complies with the requirements of the European Pharmacopoeia, was included into the general monograph OFS.1.2.4 ...
T. A. Batuashvili, L. V. Simutenko, N. P. Neugodova, P. V. Shadrin   +3 more
doaj   +1 more source

Medicines manufactured in pharmacies: features of validation of analytical methods and tests (Prior to the introduction of the monograph section of the SPU)

Фармацевтичний журнал, 2021
In most foreign countries, compounding medicines preparation are an important element of the pharmaceutical sector, the formulation of which is being distributed and developed taking into account the needs of today. Legal regulation of the circulation of
O. A. Yevtifieieva, V. A. Georgiyants
doaj   +1 more source