www.biopharminternational.com October 2020 BioPharm International eBook 25
Figure 4. Interpretation of United States Pharmacopeia (USP) <731> into an analytical procedure for an individual laboratory.
Analytical Test
Procedure
Record test specific
information
Sample amount to be dried in
weighing bottles
Oven drying
Cooling in desiccator
Sample dried amount in
weighing bottles
Second Person Review
BETAMETASONE VALERATE
Loss of Drying
Analysis:
Dry it at 105° for 3 hours
Acceptance criteria:
It loses not more than 0.5%
of its weight
<731>
Loss on Drying
<41>
Balances
<1251>
Weighing on
an Analytical
Balance
Interpretation of
USP monograph
test requirement
Calculation of % LOD and
comparison with standard
General
Notices
Competent
analyst
Data Integrity
Policy
<1029>
Good
Documentation
Guidelines
Regulatory Sourcebook Data Integrity
INTERPRETING PHARMACOPEIAL
REQUIREMENTS FOR
USP <731>
How ca n a USP genera l c hap -
ter be best interpreted?
Figure 4
shows the authors' proposal; on
the left-hand side are three inputs:
trained and competent analysts,
a data integrity policy, and USP
General Chapter <1029> on Good
Documentation Practices.
The USP betamethasone val-
erate monograph requirement for
LOD requires inputs from the gen-
eral notices as well as the following
general chapters in addition to USP
<731> (16), namely USP <41> and
USP <1251> (23, 24). From these
inputs, an analytical procedure pro-
cess flow for LOD can now be devel-
oped and is shown on the right-hand
side of
Figure 4. There is also a spe-
cific direct input from USP <1029>
(14) into the procedure for second
person review, which is consistent
with the requirement in 21 CFR
211.194(a)(8) (15).
The detailed interpreted analytical
procedure is shown in
Figure 5. On
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