2 / 3
6.
System suitability tests and/or analytical quality control:
47
Suitable methods will include blank check samples, and check standards at the lowest point
48
and midrange point of the analytical range.
49
50
7.
Potential Reference Material(s):
51
52
Testing materials can be obtained from Charles Metcalfe, Custom Analytics.
53
Contact:
+1(803) 499-4469
o
r cem@calabs.us54
55
Refer to Annex F:
Development and Use of In-House Reference Materials
in
Appendix F:56
Guidelines for Standard Method Performance Requirements
, 19
th
Edition of the AOAC
57
INTERNATIONAL Official Methods of Analysis (2012). Available at:
58
http://www.eoma.aoac.org/app_f.pdf59
60
61
8.
Validation Guidance
:
62
Information on analytical performance for all claimed matrixes must be submitted.
63
Demonstrate ability to correctly identify acetylated glucomannan polysaccharides derived
64
from Aloe Vera from the potential adulterants listed in table 3. Validation test samples
65
should be blind coded, and randomly mixed with respect to presence and absence of target
66
and potential adulterants.
67
68
Appendix D:Guidelines for Collaborative Study Procedures To Validate Characteristics of a
69
Method of Analysis; 19
th
Edition of the AOAC INTERNATIONAL Official Methods of Analysis
70
(2012). Available at:
http://www.eoma.aoac.org/app_d.pdf71
72
Appendix F:Guidelines for Standard Method Performance Requirements; 19
th
Edition of
73
the AOAC INTERNATIONAL Official Methods of Analysis (2012). Available at:
74
http://www.eoma.aoac.org/app_f.pdf75
76
Appendix K: Guidelines for Dietary Supplements and Botanicals, Official Methods of
77
Analysis (current edition), AOAC INTERNATIONAL, Rockville, MD, USA (
http://www.eoma.78
aoac.org/app_k.pdf). Also at: J. AOAC Int. 95, 268(2012); DOI: 10.5740/jaoacint.11-447
79
80
Appendix N: ISPAM Guidelines for Validation of Qualitative Binary Chemistry Methods.
81
82
9.
Maximum Time-To-Result:
None
83
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85
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87