20 Questions
What does pharmaceutical analysis involve?
The determination and separation of active pharmaceutical ingredients
According to RA 10918, what do pharmaceutical products refer to?
Medicines and veterinary products
What do drugs refer to according to RA 10918?
Chemical compounds for disease prevention
Which official compendium is mentioned in the definition of terms according to RA 10918?
Japanese Pharmacopeia
According to RA 10918, which articles are included in the definition of drugs?
Articles affecting the structure or function of the human body or animals
What is the purpose of pharmaceutical analysis?
To elucidate the structure of compounds in pharmaceutical products
According to RA 10918, what do drugs refer to?
Only chemical compounds for disease prevention
Which substances are considered pharmaceutical products according to RA 10918?
Drugs and medicines only
What are the components to which pharmaceutical analysis is done?
Active pharmaceutical ingredients and drug metabolites
What is included in the term 'pharmaceutical products' according to RA 10918?
Biologicals and veterinary products
According to the European Pharmacopeia, a medical product is defined as:
Any substance or combination of substances that may be used to restore, correct or modify physiological functions in human beings and/or animals
What is the active ingredient (AI) or active pharmaceutical ingredient (API) in a medical product?
Any substance intended to be used in the manufacture of a medicinal product and that becomes an active ingredient of the medicinal product
What is an excipient according to the European Pharmacopeia?
Any constituent of a medicinal product that is not an active substance
What is pharmaceutical quality assurance (QA) according to the European Pharmacopeia?
Sum of all activities and responsibilities required to ensure that the medicine that reaches the patient is safe, effective, and acceptable
What is pharmaceutical quality control according to the European Pharmacopeia?
Process concerned with medicine sampling, specifications, and testing, and with the organization’s release procedures
What do poor quality medicines result in according to the text?
Adverse effects and toxic effects
What is an herbal medical product according to the European Pharmacopeia?
A medicinal product exclusively containing one or more herbal drugs or herbal drug preparations
What are adjuvants, stabilizers, antimicrobial preservatives, diluents, antioxidants according to the European Pharmacopeia?
Excipients - constituents of a medicinal product that are not active substances
Which statement best describes an active pharmaceutical ingredient (API)?
Any substance intended to be used in the manufacture of a medicinal product and that becomes an active ingredient of the medicinal product
According to European Pharmacopeia, what is an excipient?
A constituent of a medicinal product that is not an active substance
Test your knowledge of the processes used for identification, determination, separation, purification, and structure elucidation of compounds in pharmaceutical products, including active pharmaceutical ingredients, pharmaceutical excipients, contaminants, and drug metabolites.
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