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71 Cards in this Set

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  • Back
gross errors
easy to recognize because they involve a major breakdown in the analytical process such as samples being split, wrong dilutions being prepared, or instruments breaking down or being used in the wrong way
systematic errors
characterized by precise and inaccurate measurement results
random errors
characterized by widely scattered ie. imprecise, measurement results
standard deviation
the calculated value provides a fomal expression of the scatter in the results from an analysis rather than the visual judgement shown previously
analytical procedure
provides an exact description of how the analysis is carried out
precision
expresses the closeness of agreement (degree of scatter) between a series of measurements obtained from multiple sampling of the same homogenous sample
repeatability
the precision obtained under the same operating conditions over a short period of time (an assay is repeated by the same person using the same equipment)
intermediate precision
expresses the within-lab variation of precision when the analysis is carried out by different analysts, on different days, and with different equipment
reproducibility
expresses the precision between labs such as when a method is transferred from one part of a company to another
accuracy
the simplest method is to compare a substance being analyzed with a reference standard analyzed by the same procedure (the reference standard is a highly characterized form of the durg that has been subjected to extensive analysis
system suitability
relates to the performance of the analytical equipment (the four Q's rule)...design qualification, installation qualification, operational qualification, and performance qualification
analytical blank
consists of all of the reagents or solvents used in an analysis without any of the analyte being present
calibration
comparison of the value or values of a particular parameter measured by the system under strictly defined conditions with pre-set standard values
limit of detection
the smallest amount of an analyte which can be detected by a particular method
limit of quantification
the smallest amount of an analyte which can be quantified reliably
linearity
most analytical methods are based on processes where the method produces a response that is linear and which increases or decreases linearly with analyte concentration
range
refers to the interval between the upper and lower concentration of an analyte for which an acceptable level of precision and accuracy has been established
robustness
evaluated to determine how resistant the precision and accuracy of an assay are to small variations in the method (eg. the stability of analytical solutions, or the length of sample extraction time)
selectivity
the measure of how capable a method is of measuring the analyte alone in the presence of other compounds contained in the sample
sensitivity
indicates how responsive the method is to a small change int he concentration of an analyte (may be viewed as the slope of a linear response curve)
weighing by difference
where the sample is weighed in a suitable vessel, ie. a glass weighing boat with a spout, and then transferred immediately to the vessel in which it is going to be analyzed or dissolved and the weighing vessel is reweighed and the difference between the wrights before and after transfer gives the weight of the sample
percentage volume/volume (%v/v)
often encountered in relation to the composition of mobile phases used in high pressure liquid chromatography
percentage weight/volume (%w/v)
usually used to express the content of an active ingredient in liquid formulations such as injections, infusions, and eyedrops
percent weight/weight (%w/w)
a common measure used to express the concentration of active ingredient in a formulation such as a cream
parts per million (ppm)
a common measure used for impurities in drug substances, particularly heavy metals and solvents
physical properties of drug molecules, such as _____, along with simple chemical ________ and degradation reactions, play an important part in the design of analytical methods
pka and partition coefficient

derivatisation
when pka is used to measure acidic or basic strength,
for an acid, the smaller the pka value - the stronger the acid, and for a base, the larger the pka value - the stronger the base
the most effective range for a buffer....
is 1 ph unit either side of the pka value of the weak acid or base used in the buffer
the partition coefficient for a compound (P) can be simply defined as _______.
P = Co/Cw
Co is conc. of substance in an organic phase, and Cw is conc. of substance in water
the ______ the more a substance has an affinity for the organic media
greater P
many drugs contain ionisable groups and their partition coefficient at a given pH may be difficult to predict if more than one ionisable group is involved; however, _____.
often one group in a molecule may be very much more ionized than another at a particular pH, thus governing its partitioning
In zero order kinetics, the rate of degradation is _______.
independent of the concentration of the reactants
First Order Degradation. This type of degradation would be typical of ______.
hydrolysis of a drug in solution
the ________ about the double bond ensures that the stereochemistry of this drug and its isomer are different
lack of free rotation
when a compound ___________ about a particular carbon atom, the carbon atom is said to be a chiral center
has no symmetry
a chiral center arises when a carbon atom _______.
has 4 structurally different groups attached to it
the ______ attached to the chiral carbon atom, often hydrogen, is placed behind the plane of the paper with all of the other groups pointing forward
group with lowest priority
the priorities are assigned to the atoms immediately attached to the chiral center in order of ___.
decreasing atomic mass
when _______ is present in a molecule, there is the possibility of diastereoisomers
more than one chiral center
Analytical derivatization is employed for two reasons:
to improve the analysis by improving the _______.
to improve the analysis by improving chromatographic behavior or detectibility, ie., ______.
selectivity

sensitivity
analytical derivatization reactions are a form of synthetic organic chemistry in which the goal is ______.
100% yield of a single pure product
radiation in the wavelength range _______ is passed through a solution of drug
200-700nm
most drug molecules absorb radiation in the UV region of the spectrum, ie. ________.
100-350nm
short wavelength UV radiation _______ can cause the strongest bonds in organic molecules to break
less than 150nm
weaker bonds in molecules are of more interest to the analyst because they can be excited by longer wavelength UV radiation ________ which is at a longer wavelength than the region in which air and common solvents absorb
200nm
chemical substructures that are responsible for the absorption of electromagnetic radiation are called ______.
chromophores
a most common ______ in drug molecules is the _______.
chromophore

aromatic ring, such as the benzene ring
the _______ by a solution of molecules is governed by the Beer-Lambert Law
measurement of light absorption
the beer lambert equation
A=A(1%,1cm)bc
since measurements are usually made in a 1cm cell, the equation can be written as ______ which gives the concentration of the analyte in g/100mL
c= A/A(1%,1cm)
the ______ a deuterium lamp for the UV region from 190 to 350nm and a quartz halogen or tungsten lamp for the visible region from 350 to 900 nm
light source
the ______, used to disperse the light into its constituent wavelengths
monochromator
the ______ may be designed to split the light beam so that the beam passes through two sample compartments, and, in such a double beam instrument, a blank solution can then be used in one compartment to correct the reading or spectrum of the sample
optics
______ are generated in a high vacuum region, or immediately prior to a sample entering region, or immediately prior to a sample entering a high vacuum region, using a variety of methods for ion production
charged molecules or molecular fragments
GC/MS and LC/MS provide highly sensitive and specific methods for determining drugs and their ___________.
metabolites in biological fluids and tissues
quadrupole instrument
_______ mass spectrometer than a magnetic sector instrument.
cheaper and more sensitive
electrospray ionization
the most common ________

spectra may contain the _____ only
LC/MC detection interface

molecular ion
_______ is the most frequently used analysis technique in pharmaceutical analysis
chromotograph
if a compound __________, it will travel through the column at the same rate as the solvent
doesn't partition appreciably into the stationary phase
the length of time it takes a retained compound to pass throgh the column depends on the compounds _______ which is a measure of the degree to which the compound partitions (adsorbs) into the stationary phase from the mobile phase
capacity factor (K1)
calculation of column efficiency
the _____ a chromatographic peak is relative to its retention time, the less efficient the column it is eluting from
broader
where n is the number of ______, where tr is the time taken for the compound to pass through the column, where w1/2 is the width of the peak at half its height
theoretical plates
_______ is usually expressed in theoretical plates per meter, or n x (100 cm/m)/L
column efficiency
silica gel, a _____ column packing, where the mechanism of retaining a compound is by ____ onto the polar groups of the stationary phase
normal phase

adsorption of the polar groups of a molecule
octadecylsilane-coated (ODS coated) silica gel, a ______ column packing, where the mechanism of retaining a compound is due to _____ into the stationary phase
reverse phase

partitioning of the lipophilic portion of a molecule
HPLC
for neutral compounds it is the balance between its ____ which will determine the time it takes to elute from an HPLC column
polarity and lipophilicity
in the case of a reverse-phase column (ODS-coated silica gel), the ____ a compound is the more it will be retained
more lipophilic
in the case of a normal phase column (silica gel), the ____ a compound is the more it will be retained
more polar
the control of the rate of elution via control of the pH of the mobile phase is only applicable to compounds in which the _____ (the majority of common drugs)
degree of ionization is dependent on pH
for the majority of analyses of drugs in formulations, variable wavelength ____ are used which are based on the absorption of UV light by an analyte
UV detectors
______ (ELSD) which is based on the scattering of a beam of light by particles of compound remaining after evaporation of the mobile phase
Evaporative Light Scattering Detector