Chemistry Reference
In-Depth Information
the characteristics of hardness/friability have a critical impact on product quality
(e.g., chewable tablets).
6.6.4 u
nIformIty
of
d
oSAge
u
nItS
Uniformity of dosage units in this context refers to both the mass of the dosage form
and the content of the active ingredient in the formulation. In general, pharmacopeial
methods should be used [12].
6.7 specIFIc tests/crIterIA: neW orAl
lIQuId drug products
For oral liquid drug products (and powders intended to be reconstituted as oral liq-
uids), many of the same tests as for solid dosage forms are still appropriate (e.g., uni-
formity, dissolution, water content), but additional specific additional tests include
pH (acceptance criteria and proposed range justified), antimicrobial and antioxidant
preservative contents, extractables, alcohol content, particle size distribution, redis-
persability, rheological properties, and reconstitution time. More details concerning
each of these tests can also be obtained directly from the guidelines as space allows
only a brief summary here.
For formulations using an antimicrobial or antioxidant, criteria for preservative
content should be established. The establishment of criteria for preservative content
is usually established by shelf-life stability testing according to established guide-
lines [13].
Extractables are normally evaluated during development and stability; and after
levels are shown to be consistently below acceptable and safe values, elimination of
the test is acceptable.
For products that contain alcohol as declared on the label, the content should be
specified and quantitative results obtained by assay or calculation.
Some liquid dosage forms can settle on storage, necessitating specifications for
redispersability, requiring either mechanical or manual shaking for a predetermined
length of time.
For viscous solutions or suspensions, specifications governing rheological proper-
ties, such as viscosity, may be appropriate. Both the test and the acceptance criteria
should be stated.
A reconstitution specification is appropriate for powder products that require
reconstitution. The choice of diluents should be justified.
6.8 specIFIc tests/crIterIA: pArenterAl drug products
In addition to some of the foregoing tests, several tests specific to parenteral products
must be considered, including a test for endotoxins and pyrogens (typically a limulus
amoebocyte lysate test), particulate matter (an acceptance criteria for visible particu-
lates and solution clarity), functionality testing of delivery systems (test procedures
and acceptance criteria for the functionality of prefilled syringes or cartridges), and
osmola r it y.
