| Accuracy |
Indicates how closely an analytical or assay procedure
approaches the true value for a particular sample. (Note that this
requires knowing what the true value is.) |
| Adjuvant |
A material that enhances the action of a drug or antigen
|
| Alcohol |
Unless otherwise specified, ethyl alcohol (ethanol).
Concentration is normally in percent by volume. "Dehydrated alcohol",
or "Absolute alcohol" is 100%. |
| Analyte |
The specific substance to be determined in an assay
or analysis |
| Assay, Analysis |
Properly, an 'assay' determines how much of some particular
material is in the sample (such as an assay for the Aspirin contentof
Aspirin tablets).An 'analysis' generally determines (more or less)
everything in the sample. An analysis of a rock would determine the
content of calcium, magnesium, lithium, . . . . , and the length of
the list would depend primarily on the sensitivity of the analysis.Both
assays and analyses generally use similar procedures and instruments,
but an analysis may be qualitative, reporting what is detected, or
quantitative, reporting how much is found. An assay is always quantitative.
|
| Bioavailability |
Indicates measurement of the rate and amount of drug
that reaches the general circulation from an administered dosage form.
|
| Bioequivalence |
Indicates that a drug in two or more similar dosage
forms reaches the general circulation at the same relative rate and
the same relative extent. |
| Compendial |
Official; purported to comply with USP or NF. |
| CS |
Colorimetric solution (defined in USP/NF). |
| Disintegration |
Breaking up of a tablet in water or in simulated gastric
and/or simulated intestinal fluid to the point that the particles
pass through a fine screen. |
| Dissolution |
Generally, dissolving; but specifically, a USP test
which determines how rapidly the active ingredients of a dosage form
dissolve. The test is generally done with six tablets in containers
with very specifically defined dimensions, stirring mechanisms, etc.
|
| Dosage form |
A pharmaceutical product as produced for use (tablet,
capsule, etc.) |
| Excipient |
Any component other than the active substance(s) that
is intentionally added to the formulation of a dosage form; "added
substance". The term includes binders, fillers, disintegrants, and
lubricants. |
| Expiration date |
A date, determined by stability tests, after which
the product may not meet the USP requirements. Expiration dates are
generally limited to no more than 3 years after production, but longer
stability periods are allowed for some very stable materials such
as sulfur or sodium chloride. |
| G |
If followed by a number, a chromatographic phase; e.
g., G4 is diethylene glycol succinate polyester. Defined in USP/NF.
|
| GCP |
Good Clinical Practice : requirements for tests on
human subjects |
| GLP |
Good Laboratory Practice: in the pharmaceutical context,
requirements for 'nonclinical' tests on animals. It does not cover
chemical or microbiological testing of raw materials or products.
|
| GMP |
Good Manufacturing Practice: in the pharmaceutical
context,these are the requirements covering all aspects of pharmaceutical
manufacture, including chemical and microbiological testing of raw
materials and products. |
| Identification: |
In USP, a relatively quick presumptive test to verify
that a material is what the label says it is. These are not final
proof of identity, and related substances may have the same tests.
|
| L |
If followed by a number, a chromatographic column packing.
E. g.: L1 is octadecyl silane chemically bonded to porous silica or
ceramic particles 3 to 10 µm in diameter. Defined in USP/NF.
|
| Label |
The information on the 'immediate' container of a an
item. |
| Labeling |
Information on the label and all other material accompanying
the product. |
| LAL |
Limulus amoebocyte lysate: an in vitro test for bacterial
endotoxins |
| Limit of detection |
The lowest concentration of an analyte that can be
detected reliably (present or absent) in a particular sample. Exact
definitions vary. |
| Limit of quantitation |
The lowest concentration of an analyte that can be
determined quantitatively (at acceptable precision) in a particular
sample. Exact definitions vary. |
| Limit tests |
Typically qualitative tests which show whether the
concentration of a particular substance is above or below the USP/NF
limit (usually for arsenic, calcium, sodium, potassium, chloride,
sulfate, heavy metals, iron, or selenium). Some limit tests are much
more extensive, notably those for lead and mercury. Microbial limit
tests are usually for total aerobic count, or for presence of Staphylococcus
aureus, Pseudomonas aeruginosa, Salmonella, or Escherichia coli in
substances which are not required to be sterile. |
| Linearity |
A measure of how closely a graph of measurement result
versus analyte concentration fits a straight line. Best stated as
the range in which the measurement is linear within certain specified
limits. Note that data may be 'transformed' mathematically, as in a
plot of the logarithm of the measurement result versus the
concentration. Note, too, that a mathematical definition will be
more complex. |
| Monograph |
The entry in USP or NF for a specific raw material
or product. |
| Negligible |
Not more than 0.50 mg (US) |
| Official |
Compendial; purported to comply with USP or NF |
| Precision |
Agreement of the results of several independent assays
of the same sample. Usually reported as a standard deviation of a
specified number of assays. Note that this is about how the measurements
are related to each other, and does not indicate how near any one
measurement or the mean of several measurements, is to the true value,
if that is known. |
| Pyrogens |
Substances which cause fever if they are present in
an injection. Most of them are bacterial endotoxins (lipid constituents
of the cell walls of Gram-negative bacteria). The standard pyrogen
test measures temperature increases in 3 rabbits. See also "LAL".
|
| RS |
Reference standard (typically a substance carefully
prepared by (or for) the US Pharmacopeial Convention) |
| Range |
The lowest and highest concentrations between which
an assay is linear. |
| Robustness |
Lack of effect of deliberate variations in the analytical
procedure on the result |
| Ruggedness |
A showing of how little measurements are influenced
by being done by different analysts, in different laboratories, etc.
|
| S |
If followed by a number, a chromatographic support.
E. g., S7 is graphitized carbon with a nominal surface area of 12
m2/g. (Defined in USP/NF.) |
| Stability testing |
Determination of the period over which a product continues
to meet the USP specifications, generally by long-term 'real time'
tests at room temperature and about 65% relative humidity. Accelerated
tests (40o C, 75% RH) are used to determine tentative stability periods
for new formulations. |
| Solubility |
Stated in terms of the parts of solvent needed to dissolve
one part of the solute (US): |
| |
|
Very soluble |
< 1 |
| |
|
Freely soluble |
1 - 10 |
| |
|
Soluble |
10 - 30 |
| |
|
Sparingly soluble |
30 - 100 |
| |
|
Slightly soluble |
100 - 1000 |
| |
|
Very slightly soluble |
1000 - 10,000 |
| |
|
Insoluble |
> 10,000 |
| Solutions |
w/w: percent by weight: grams per 100 g of solution
|
| |
w/v: percent by volume: grams per 100 ml
of solution |
| |
v/v: percent by volume in volume;
ml per 100 ml of solution |
| Specificity |
Ability of an assay procedure to avoid interference
from other materials in the sample. |
| Sterility test |
A test generally done on finished products which are
to be injected. Direct transfer: 40 samples of the product are placed
in separate containers of an aerobic growth medium (20 samples) and
an anaerobic growth medium (20 samples) and incubated for at least
7 days.Membrane filtration: liquids (typically, the contents of 20containers)
are forced, in a closed system, through two separate membrane filters
(typically 0.45 µm pore size). Then aerobic and anaerobic growth
media are placed on the separate filters and cultured for at least
7 days. No growth is allowed in any of the media. |
| System suitability tests |
Tests intended to determine whether a 'system' including
instruments, analysts, etc., is capable of performing a particular
process, test or assay |
| Temperatures (USP) |
|
Freezer |
-10 to -20o C |
| |
|
Cold |
< 8o C |
| |
|
Refrigerator |
2 to 8o C |
| |
|
Cool |
8 to 15o C |
| |
|
Controlled room temperature |
20 - 25o C |
| |
|
Warm |
30 - 40o C |
| |
|
Excessive |
> 40o C |
| TS |
Test solution (defined in USP/NF for a particular test)
|
| Validated |
Means that a method (or instrument, process, etc.)
has been tested and shown to do, reliably, what it is supposed to
do. For analytical methods, the testing generally covers accuracy,
precision, specificity, limit of detection, limit of quantitation,
linearity and range, ruggedness, and robustness. |
| VS |
Volumetric solution (defined in USP/NF for a particular
analysis) |
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