Stakeholder Panel Meeting Book - September 6, 2014 - page 151

3
5.
System suitability tests and/or analytical quality control:
71
Suitable methods will include blank check samples, and check standards at the lowest point
72
and midrange point of the analytical range.
73
74
6. Reference Material(s):
75
NIST Standard Reference Material
®
1849a; Infant/Adult Nutritional Formula - or equivalent.
76
The SRM is a milk-based, hybrid infant/adult nutritional powder prepared by a manufacturer
77
of infant formula and adult nutritional products. A unit of SRM 1849 consists of 10 packets,
78
each containing approximately 10 g of material. Certified value of NIST1849a is 20.37
±
0.52
79
mg/Kg of riboflavin.
80
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7. Validation Guidance
:
82
Recommended level of validation:
Official Methods of Analysis
SM
.
83
84
8. Maximum Time-To-Result
: No maximum time.
85
1...,141,142,143,144,145,146,147,148,149,150 152,153,154,155,156,157,158,159,160
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