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Technical Glossaries




Guns and Ammo

Microbiology Glossary

Optical Microsopy

--- German/English
Pharmaceutical Terminology

Some Pharmaceutical Analysis/Testing Terminology (all in the pharmaceutical laboratory context)

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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