Study Set Content:
The resulting signals are transformed
into a
user-friendly spectra
Similar to X-ray
diffraction
Raman spectrometry
a laser is focused on a sample and is scattered based on
the sample’s chemical composition.
Raman spectrometry
is a common approach for
evaluating contamination and impurity of a
sample and has the advantage over FTIR and
Near IR in that samples containing water or
liquid mixtures can be quickly analyzed.
Raman spectrometry
OTHER APPROACHES
(ELISA):
Enzyme-linked immunosorbent assay
are commonly used to measure
large molecules like proteins and antibodies
including common allergens.
Immunoassays
allow relative quantification and confirmation of
larger compounds not possible with other
techniques.
ELISA assays
(PCR)
Polymerase Chain Reaction
is used to amplify specific genes in a sample.
PCR
This technique can be targeted at a gene only in
specific ingredients, or for a subset of genes
that are unique to a sample.
PCR
is most often used for identification of detection of common adulterants.
PCR
Microscopy
light, fluorescence,
polarized light,
Scanning Electron Microscopy (SEM)
Transmission Electron Microscopy (TEM)
can be used to evaluate the
microscopic structure of materials with
magnification as high as 100,000X
Microscopy
This is most
commonly done for raw materials, as processing
procedures typically disrupt the true morphology
of a material
Microscopy
Microscopic techniques are also
useful to identify foreign materials such as
plastic, metal and glass when combined with
_____ for elemental profiling.
EDXA/EDS
commonly defined as a highly purified
compound that is well characterized, the quality
and purity of reference standards are very
crucial in determining scientifically reasonable
results for the analytical methods in the
pharmaceutical industry and are also very well
designated by FDA (US Food and Drug
Administration) or a company or laboratory.
Reference Standard Material
used to determine quantitative data (such as
assay and impurity), qualitative data (such as
identification test), and calibration (such as
melting point standard).
Reference Standard Material
assay and impurity
quantitative data
identification test
qualitative data
melting point standard
calibration
