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EudraLex consists of 10 volumes: Concerning Medicinal Products for Human use: Volume 1 - Pharmaceutical Legislation. Volume 2 - Notice to Applicants. Volume 2A deals with procedures for marketing authorisation. Volume 2B deals with the presentation and content of the application dossier. Volume 2C deals with Guidelines. Volume 3 - Guidelines.
The Poisons Standard organises substances into 10 schedules (and unscheduled substances), [10] therapeutic goods are generally organised only into schedules 2, 3, 4 and 8: unscheduled substances: unscheduled substances are available for purchase at any retailer. schedule 1 (S1) - Blank: this schedule is left intentionally blank.
EudraLex, Volume 4, Chapter 1) The QP is typically a licensed pharmacist, biologist or chemist (or a person with another permitted academic qualification) who has several years' experience working in pharmaceutical manufacturing operations, and has passed examinations attesting to his or her knowledge. The requirement for QP oversight has been ...
Cover of the European Pharmacopoeia, 11th Edition. 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]
While each document (and each language version) is an individual part of the database, the content is grouped into sectors. There are currently 12 sectors, each represented by a number or a letter: [10] 1 - Treaties; 2 – International agreements; 3 – Legal acts; 4 – Complementary legislation; 5 – Preparatory documents; 6 – Case-law
Heparin is an anticoagulant, and if used as a catheter lock solution it could leak into the blood circulation of the patient. Therefore it has been associated with catheter-related bleeding and heparin induced thrombocytopenia (HIT). [8] [9] Citrate catheter lock solutions are being used in three different concentrations – 4%, 30% and 46.7%.
If one adds 1 litre of water to this solution, the salt concentration is reduced. The diluted solution still contains 10 grams of salt (0.171 moles of NaCl). Mathematically this relationship can be shown by equation: = where c 1 = initial concentration or molarity; V 1 = initial volume
Dakin's solution is a dilute solution of sodium hypochlorite (0.4% to 0.5%) and other stabilizing ingredients, traditionally used as an antiseptic, e.g. to cleanse wounds in order to prevent infection. [1] The preparation was for a time called also Carrel–Dakin solution or Carrel–Dakin fluid. [2]