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Retrieved 4 April 2018. 1.2.3.3 Definition of Room Temperature: According to the United States Pharmacopeia National Forumlary [ sic] (USP-NF), the definition of room temperature is between 15 and 30 °C in the United States. However, in the EU, the room temperature is defined as being 15 to 25 °C, while in Japan, it is defined being 1 to 30 °C.
The USP Controlled Room Temperature is a series of United States Pharmacopeia guidelines for the storage of pharmaceuticals; [1] the relevant omnibus standard is USP 797. [2] [3] Although 100% compliance remains challenging for any given facility, [4] the larger protocol may be regarded as constituting a form of clean room [5] which is included in a suite of best practices.
The 1699 Edinburgh Pharmacopoeia. A pharmacopoeia, pharmacopeia, or pharmacopoea (from the obsolete typography pharmacopœia, meaning "drug-making"), in its modern technical sense, is a book containing directions for the identification of compound medicines, and published by the authority of a government or a medical or pharmaceutical society. [1]
The United States Pharmacopeia ( USP) is a pharmacopeia (compendium of drug information) for the United States published annually by the over 200-year old United States Pharmacopeial Convention (usually also called the USP), a nonprofit organization that owns the trademark and also owns the copyright on the pharmacopeia itself.
A Karl Fischer titrator. In analytical chemistry, Karl Fischer titration is a classic titration method that uses coulometric or volumetric titration to determine trace amounts of water in a sample. It was invented in 1935 by the German chemist Karl Fischer. [ 1][ 2] Today, the titration is done with an automated Karl Fischer titrator.
The European Pharmacopoeia[ 1] ( Pharmacopoeia Europaea, Ph. Eur.) is a major regional pharmacopoeia which provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of medicines, and the substances used to manufacture them. [ 1] It is a published collection of monographs which describe both the ...
In thermodynamics, the Volume Correction Factor (VCF), also known as Correction for the effect of Temperature on Liquid (CTL), is a standardized computed factor used to correct for the thermal expansion of fluids, primarily, liquid hydrocarbons at various temperatures and densities. [ 1] It is typically a number between 0 and 2, rounded to five ...
The International Pharmacopoeia ( Pharmacopoeia Internationalis, Ph. Int.) is a pharmacopoeia issued by the World Health Organization [ 1] as a recommendation, with the aim to provide international quality specifications for pharmaceutical substances (active ingredients and excipients) and dosage forms, [ 2] together with supporting general ...