Results 1 to 10 of about 3,069 (151)

Harmonisation of Pharmacopoeial Requirements for Identification of Closely Related Species in Herbal Medicinal Products

open access: yesРегуляторные исследования и экспертиза лекарственных средств, 2022
Global interest in herbal medicinal products is growing, thus increasing the demand for medicinal plant raw materials. However, the growth in sales of raw materials entails the risk of a wider spread of counterfeit and substandard medicinal products. The
O. V. Evdokimova   +4 more
doaj   +2 more sources

Culture Media in Pharmacopoeial Analysis: Use, Current Requirements, Standardisation

open access: yesБиопрепараты: Профилактика, диагностика, лечение, 2019
Culture media with predetermined specific characteristics play a key role in ensuring safety, quality and efficacy of medicinal products, especially biologicals.
S. M. Sukhanova, N. E. Zakharova
doaj   +3 more sources

Pharmacopoeial requirements for elemental impurities in radiopharmaceuticals (review)

open access: yesРегуляторные исследования и экспертиза лекарственных средств
INTRODUCTION. Current risk-based general strategies for the control of elemental impurities in medicinal products, as documented in the elemental impurity monographs of national and world pharmacopoeias, do not apply to radiopharmaceuticals ...
V. M. Shchukin   +4 more
doaj   +2 more sources

Comparative Analysis of Russian and Foreign Pharmacopoeial Requirements for the Quality Control of Water for Injection: Challenges and Ways of Harmonisation

open access: yesБиопрепараты: Профилактика, диагностика, лечение, 2019
Parenteral dosage forms are dissolved using sterile water for injection whose quality is regulated by special requirements. The lack of a monograph on sterile water for injection in the State Pharmacopoeia of the Russian Federation, as well as the ...
S. M. Sukhanova, N. M. Minaeva
doaj   +3 more sources

Content uniformity of quartered hydrocortisone tablets in comparison with mini-tablets for paediatric dosing [PDF]

open access: yesBMJ Paediatrics Open, 2018
Objectives Children requiring cortisol replacement therapy are often prescribed hydrocortisone doses of 2.5 mg, but as this is commercially unavailable 10 mg tablets, with functional break lines, are split commonly in an attempt to deliver the correct ...
Jude Madathilethu   +5 more
doaj   +3 more sources

Microbiological Contamination of Medicinal Products —Is It a Significant Problem? [PDF]

open access: yesPharmaceuticals
Medicinal products available on the market should be characterised by therapeutic efficacy, high quality, and safety for patients. They must either be sterile or comply with the appropriate pharmacopoeial microbiological purity requirements ...
Stefan Tyski   +2 more
doaj   +2 more sources

Current and Future Pharmacopoeial Requirements for the Quality of Extemporaneous Medicinal Products: A Review of Regulatory Standards

open access: yesРегуляторные исследования и экспертиза лекарственных средств
INTRODUCTION. The organisation of extemporaneous compounding in pharmacies is currently considered to be a priority for the national healthcare system.
L. I. Shishova   +2 more
doaj   +2 more sources

Proposal of a new chemical marker for the quality control of the herb Scleromitrion diffusum [PDF]

open access: yesFrontiers in Chemistry
Baihuasheshecao (Scleromitrion diffusum (Willd.) R.J. Wang), a traditional Chinese medicinal herb, is extensively used as an ingredient in herbal teas and is a well-known folk medicine in China.
Tao Zheng   +21 more
doaj   +2 more sources

Role of Scientific Centre for Expert Evaluation of Medicinal Products in Setting Current Pharmacopoeial Requirements

open access: yesРегуляторные исследования и экспертиза лекарственных средств
The State Pharmacopoeia is  a  strategic  document  that  stipulates  safety  and quality standards in Russia. Its current progress directly correlates with the functioning of Scientific Centre for Expert Evaluation of Medicinal Products (Ministry of ...
V. L. Bagirova
doaj   +2 more sources

Post-marketing quality assessment of some brands of rosuvastatin tablets available in Jos, North-Central Nigeria [PDF]

open access: yesBMC Chemistry
Rosuvastatin is a synthetic statin medication approved for the management of lipid disorders and also for preventing cardiovascular disease in at-risk individuals.
Ukpe Ajima   +4 more
doaj   +2 more sources

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