Study Set Content:
TYPES OF REFERENCE STANDARDS
1. Laboratory-made Reference Standards
2. Company Reference Standards
3. Official Reference Standards
4. Primary Reference Standards
5. Secondary Reference Standards
6. Supplementary Reference Standards
Type of Reference STD
Assays
Degradation Products
Process Impurities
Resolution Standard
Metabolites Standard
To determine the potency of active
pharmaceutical ingredients (APIs) and salts
Assays
To identify and possibly quantitate degradation products
Degradation
Products
To identify and possibly quantitate
process-related compounds
Process
Impurities
To determine assay performance or impurity
method
Resolution
Standard
To identify and possibly quantitate
substances generated through a metabolic
process
Metabolites
Standard
Reference Standards are primarily used for the
following types of analytical studies:
● Essay
● Identification tests
● Limit tests for related substances
● Analytical method validation
● System suitability for analysis techniques and in particular spectroscopic and chromatographic analysis
Calculated by finding the
differences between the individual results and the mean,
regardless of sign, then adding these differences and
dividing by the number of determination
Average Deviation (d)
Average deviation / mean;
usually expressed as percent or as a parts per thousand
Relative average deviation
preferred measure for precision
Standard Deviation
also called as coefficient variation.
Relative standard deviation
Found by dividing the standard deviation by the mean x 100
Relative standard deviation
Acceptance Criteria:
NMT (blank) tabs should exceed the limits
2 tabs
No unit should be _____ than UPL or (blank)
than the lower limit.
twice greater, twice smaller
a method, which is employed
to determine physical strength of uncoated
tablets upon exposure to mechanical shock and
attrition.
Friability Testing
Defined as the % of weight loss by tablets due
to mechanical action during the test.
FRIABILITY TEST
FRIABILITY TEST also means _____, by certain
mechanical shock and lost of material from
intact tablet
Surface Erosion
Purpose: To evaluate the ability of the tablet to
_____ during the transportation
and handling.
withstand the breakage
Equipment: ______ or
Roche Friabilator or Tumbler Test
