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SMPR Key Points
•
Quantitation of water soluble Aloe vera
polysaccharides and the following organic acids
(acetic acid, lactic acid, malic acid and isocitric acid)
including the matrix(es) in which the polysaccharides
and the acids are found);
•
NMR, GC, Colorimetric, GPC, HPLC; or any analytical
technique that meets the following method
performance requirements is acceptable.
•
It is expected that more than one technique will be
required;
•
May require developing aloe polysaccharide
standards;
SMPR Key Points
Table 1: Method performance requirements
Ingredients
Finished Products
Parameter
(Raw
Materials)
Finished
Products ‐ Solid
–
Liquid (Freeze dried
samples)
Analytical
Range (%)
1 ‐ 100
1 ‐ 100
0.15 ‐ 15
0.15 ‐ 0.5 ≥ 0.5 ‐ 100
LOQ (%)
< 0.5
< 0.5
0.15
Recovery (%)
90 ‐ 110
90 ‐ 110
≥ 50 90 ‐ 110
% RSD
≤ 10
≤ 10
≤ 20
≤ 10
r
% RSD
R
≤ 15
≤ 15
≤ 30
≤ 15