Chemistry Reference
In-Depth Information
of the active pharmaceutical ingredient (API) from potential interferences
such as degradation products, process impurities, excipients, or other poten-
tial impurities.
Standard Additions:
First used in trace metals analysis in atomic absorption or
emission spectroscopy and for organic analytes; a method of quantitating
an analyte in complex sample matrices at low levels. The method relies
on first dividing the sample solution into approximate equal fractions or
volumes, analyzing the first sample unspiked, and then spiking each addi-
tional fraction with known amounts of the authentic analyte at varying
levels (1/2x, x, 2x, 3x, etc.).
Standard Curve:
Relationship between the analytical concentration and the experi-
mental response value (also referred to as a
calibration curve
).
Stock Solutions:
Solutions prepared from reference material used for preparation of
working solutions (also referred to as
primary stock solutions
).
System Suitability:
System suitability is the checking of a system to ensure system
performance before or during the analysis of unknowns. System suitabil-
ity tests are an integral part of chromatographic methods, and are used to
verify that the resolution and reproducibility of the system are adequate
for the analysis to be performed. System suitability tests are based on the
concept that the equipment, electronics, analytical operations, and samples
constitute an integral system that can be evaluated as a whole. System suit-
ability parameters are established as a direct result of robustness studies.
Tailing:
Situation where a normally Gaussian peak has an asymmetry >1.
Validation:
A documented program that provides a high degree of assurance that a
specific process, method, or system will consistently produce a result that
accomplishes its intended purpose, meeting predetermined acceptance
criteria.
Validation Protocol:
A written plan stating how validation will be conducted and
defining acceptance criteria.
Ver i ic at ion:
An assessment of selected
Analytical Performance Characteristics
of method validation to generate appropriate relevant data as opposed
to repeating the entire validation process. Verification demonstrates that
acceptable results utilizing the laboratories' personnel, equipment, and
reagents can be obtained.
Working Solution:
Stock solution dilution used for the preparation of calibration
standards and quality control samples (also referred to as
secondary stock
solutions
).
