O`zbekiston respublikasi sog`liqni saqlash vazirligi toshkent farmasevtika instituti

Diuretics:
Drugs that increase the quantity of urine produced by kidney. 
44.
Dosage form: 
A pharmaceutical product type (e.g., tablet, capsule, solution, 
cream) that contains a drug substance generally, but not necessarily, in association 
with excipients. 
45.
Drug substance: 
The unformulated drug substance that may subsequently be 
formulated with excipients to produce the dosage form. 
46.
Enantiomeric Impurity
: A compound with the same molecular formula as 
the drug substance that differs in the spatial arrangement of atoms within the 
molecule and is a non-superimposable mirror image. 
47.
 
Endotoxin: 
A pyrogen (eg:lipopolysaccharide) derived from the cell wall of 
gram negative bacteria. Endotoxin can lead to reactions in patients receiving 
injections ranging from fever to death.
48.
Extractable
: Extractables are chemical entities, both organic and inorganic, 
that will extract from components of a container closure system or device into 
solvents under controlled conditions. 
49.
Generic Drug:
A drug for which the patents protecting the originator product 
have expired (or may be challenged). Generic products are pharmaceutically 
equivalent to a reference listed drug (same drug substance, same route of 
administration, same dosage form and same strengths) and are also therapeutically 
equivalent (typically bioequivalent for oral solid dosage forms). 
50.
Impurity
: Any component of the new drug substance that is not the chemical 
entity defined as the new drug substance. 
51.
LD
50
: 
The dose of a material which results in 50% mortality in an animal test. 
52.
Linearity:
The linearity of an analytical procedure is its ability (within a 
given range) to obtain test results which are directly proportional to the 
concentration (amount) of analyte in the sample. 
53.
Mass balance: 
The process of adding together the assay value and levels of 
degradation products to see how closely these add up to 100% of the initial value, 
with due consideration of the margin of analytical error. 
54.