38 Pharmaceutical Technology Regulatory Sourcebook October 2020 P h a r mTe c h . c o m
Data Integrity
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
Figure 4. Interpretation of United States Pharmacopeia <731> into an analytical procedure for an individual laboratory.
Analytical
Record
(on
uniquely
numbered
approved
blank
worksheet)
Steps 3 to 5; Handwritten entry
Steps 6 to 8; Printouts attached
Steps 10 to 12; Handwritten entry
Calculation & acceptance
of sample amount
Step 9; Handwritten entry
Steps 13, 16; Handwritten entry
Acceptance of drying temperatures
and calculated drying time
Steps 14 & 15;
Handwritten entry
Calculation & Acceptance of
cooling time
Step 17; Handwritten entry
Step 18; Printouts attached
Steps 19 to 23; Handwritten entry
Step 24; Handwritten entry
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
Calculation of % LOD and
comparison with standard
Figure 5. Detail of the Loss on Drying analytical procedure.
