M2.2 Flashcards
L2:
STANDARD SOLN / UNKNOWN used
0.1N H2SO4 (SULFURIC ACID)
L2:
base / known soln / primary standard used
Na2CO3 sodium carbonate
L2:
indicator used
METHYL RED
formula for AVERAGE NORMALITY
N1 + N2 + N3 / 3
L3:
sample used in content uniformity test
SODIUM BICARBONATE tablets
known conc. / standrad soln. used in assay of NaHCO3
0.1N H2SO4
indicator in assay of NaHCO3
METHYL RED
Assures that the STRENGTH of a therapeutic product REMAINS WITHIN SPECIFIED ACCEPTANCE LIMIT
CONTENT UNIFORMITY
Used to establish within limits that a product has UNIFORM AMOUNTS OF AI in batch preparations of pharmaceutical dosage forms
CONTENT UNIFORMITY TEST
2 USP SPECIFICATION FOR NaHCO3
- INDIVIDUAL ASSAY
- CONTENT UNIFORMITY BY BATCH
(INDIV ASSAY)
USP SPECIFICATION OF NaHCO3
95% - 105%
(CONTENT UNIFORMITY ASSAY)
USP SPECIFICATION OF NaHCO3
85% - 115% in each 10 dosage units
formula for %A
mL x N x mEq wt / gsx x 100
For the normality of standard sulfuric acid, use the calculated _______ in ALL trials.
AVERAGE NORMALITY
In Assay, the amount/content of analyte in a sample is determined based on the ________ reacted with the analyte.
VOLUME OF STANDARD SOLN