Chemistry Reference
In-Depth Information
A.1 IntroductIon
A.1.1 P
urPoSe
This section should describe the purpose of the study; for example, type of method
and its intended use, phase of development, required level of regulatory control. It
should also include the number and description of the test method, the analytical
performance parameters that will be investigated, and any ancillary tests (e.g., solu-
tion stability, filter studies).
A.2 test And reFerence substAnces
Each test and reference substance used in the validation should be described in
this section, along with chain of custody information. Items such as the source, lot
numbers, identification numbers, storage conditions and location, expiry dates, etc.,
should also be included.
A.3 JustIFIcAtIon oF tHe test system
This section describes the justification for the test procedure or system (e.g.,
HPLC, GC) explaining its use and applicability. Any out-of-the-ordinary meth-
odology or techniques (e.g., chromatographic modes or detection) should also be
described.
A.4
mAterIAls And metHods
A.4.1 A
nAlySIS
In this section, list the test method that will be used for sample analysis, and provide
the draft method as an attachment. State how standard and sample preparation will
be carried out (if according to the method, just specify as such). If a draft method
document is not available, all method details should be described in this section.
Typical injection sequences should also be described. For example,
solution preparation
number of Injections
Diluent Blank
2 or more
Sensitivity Standard 1
1
Sensitivity Standard 2
1
Working Standard
5
Check Standard
1
Working Standard
1
Six Samples
1×6
Working Standard
1
Six Samples
1×6
Working Standard
1
