Biomedical Engineering Reference
In-Depth Information
SOP No. QCS-016.00 Effective date: mm/dd/yyyy
Approved by:
16.1 PurPose
To provide a procedure for the rounding of significant numbers.
16.2 resPonsibility
It is the responsibility of all analysts, microbiologists, QA in-process, validation, maintenance (cali-
bration staff), and production and packaging staff to follow the procedure. All corresponding
department's managers are responsible for SOP compliance. The QA director will be responsible for
overall systems compliance.
16.3
Procedure
16.3.1 uSP c
riteria
Where limits are expressed numerically herein, the upper and lower limits of a range include the
two values themselves and all intermediate values, but no values outside the limits. The limits
expressed in monographic definitions and tests, regardless of whether the values are expressed as
percentages or as absolute numbers, are considered significant to the last digit shown.
16.3.2 e
Quivalence
S
tatementS
in
t
itrimetric
P
rocedureS
The directions for titrimetric procedure conclude with a statement of the weight of the analyte that
is equivalent to each milliliter of the standardized titrant. In such an equivalence statement, it is to
be understood that the number of significant figures in the concentration of the titrant corresponds
to the number of significant figures in the weight of the analyte. Blank corrections are to be made
for all titrimetric assays where appropriate.
16.3.3 t
oleranceS
The limits specified in the monographs for pharmacopeial articles are established with a view to the
use of these articles as drugs, except where indicated otherwise. The use of the molecular formula
for the active ingredient(s) named in defining the required strength of a pharmacopeial article is
intended to designate the chemical entity of entities, as given in the complete chemical name of the
article, having absolute (100) purity.
A dosage form shall be formulated with the intent to provide 100% of the quantity of each ingre-
dient declared on the label. Where the content of an ingredient is known to decrease with time, an
amount in excess of that declared on the label may be introduced into the dosage form at the time of
manufacture to assure compliance with the content requirements of the monograph throughout the
expiration period. The tolerances and limits stated in the definitions in the monographs for pharma-
copeial articles allow for such overages and for analytical error, for unavoidable variations in manu-
facturing and compounding, and for deterioration to an extent considered acceptable under practical
conditions.
The specified tolerances are based upon such attributes of quality as might be expected to character-
ize an article produced from suitable raw materials under recognized principles of good manufacturing
practice.
The existence of compendial limits or tolerances does not constitute a basis for a claim that an
official substance that more nearly approaches 100% purity “exceeds” the pharmacopeial quality.
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