Reading...
Play button
Play button
Use LEFT and RIGHT arrow keys to navigate between flashcards;
Use UP and DOWN arrow keys to flip the card;
H to show hint;
A reads text to speech;
40 Cards in this Set
- Front
- Back
|
Manufacturing
|
the production, preparation, propagation, conversion, or processing of a Drug or Device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis, and includes any packaging or repackaging of the substance(s) or Labeling or relabeling of its containers, and the promotion and marketing of such Drugs and Devices. Manufacturing also includes the preparation and promotion of commercially available products from bulk compounds for resale by pharmacies, Practitioners, or other Persons
|
|
|
USP, #
|
1. United States Pharmacopeia
|
|
|
NF, #
|
2. National Formulary
|
|
|
FCC, #
|
3. Food Chemical Codex
|
|
|
ACS, #
|
4. American Chemical Society's publication of Reagent Chemicals
|
|
|
AR, #
|
5. analytical reagent
|
|
|
Purified, #
|
6. designation given to chemicals of superior quality for which there is no official standard
|
|
|
CP, #
|
7. chemically pure
|
|
|
Technical, #
|
8. commercial grade, industrial quality
|
|
|
Food Grade, #
|
9. chemicals that have clearance for use in food
|
|
|
Cosmetic Grade, #
|
10. chemicals approved for use in cosmetics
|
|
|
light resistant container
|
protect the product from the effects of light
|
|
|
well-closed container
|
protection from external particles
|
|
|
tight container
|
protection from contamination by extraneous liquids, solids, or vapors, loss from the article, and from efflorescence, deliquesence, or evaporation
|
|
|
hermetic container
|
impervious to air or any other gas under normal conditions
|
|
|
very soluble
|
1 g in less than 1 ml
|
|
|
freely soluble
|
1 g in less than 10 ml
|
|
|
soluble
|
1 g in less than 30 ml
|
|
|
sparingly soluble
|
1 g in less than 100 ml
|
|
|
slightly soluble
|
1 g in less than 1000 ml
|
|
|
very slightly soluble
|
1 g in less than 10,000 ml
|
|
|
practically insoluble, or insoluble
|
1 g in more than 10,000 ml
|
|
|
stability
|
the extent to which a preparation retains, within specified limits, and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of compounding
|
|
|
types of stability
|
chemical, physical, microbiological, therapeutic, toxilogical
|
|
|
chemical stability
|
each active ingredient retains its chemical integrity and labeled potency, within the specified limits
|
|
|
physical
|
the original physical properties, including appearance, palatability, uniformity, dissolution, and suspendability, are retained
|
|
|
microbiological
|
sterility or resistance to microbial growth is retained according to the specified requirements. Antimicrobial agents that are present retain effectiveness within the specified limits
|
|
|
therapeutic
|
the therapeutic effect remains unchanged
|
|
|
toxicological
|
no significant increase in toxicity occurs
|
|
|
main factors that affect stability
|
temperature, light, humidity, oxygen, carbon dioxide
|
|
|
beyond-use dating
|
the date after which a compounded preparation is not to be used and is determined from the date the preparation is compounded
|
|
|
BUD: nonaqueous liquid and solid formulations (2 answers)
|
where the manufactured drug product is the active ingredient: 25% of the time remaining until the products expiration or 6 months
where a USP or NF substance is the source of active ingredient: 6 months |
|
|
BUD: water containing products
|
14 days in the fridge
|
|
|
BUD: other formulations
|
intended duration of therapy or 30 days
|
|
|
BUD: repackaged commercial products
|
one year or the product's expiration, whichever is sooner
|
|
|
aliquot
|
a dilution of a potent drug powder with an inert diluent powder, usually
lactose, in a definite proportion by weight. We can then remove a weighable portion (aliquot) of the mixture containing the desired quantity of substance to maintain an acceptable range of accuracy. |
|
|
triturations
|
dilutions (1:10 w/wor 10 % w/w) dilutions of potent medicinal substances, such as morphine, cocaine, etc.
|
|
|
comminution
|
particle size reduction
|
|
|
levigation
|
the process where we reduce the particle size of a powder by triturating it in a mortar and pestle or spatulating in on an ointment slab or pad with a small amount of a liquid in which the solid is not soluble (mineral oil or glycerin); used for incorporating solids into ointments, pastes, and gels
|
|
|
spatulation
|
the process of mixing powders on an ointment slab or pad using a spatula; this process does not reduce particle size
|
