September 2016 SPDS Book

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 (Raw  Materials)

Finished Products  – Liquid (Freeze dried  samples) 0.15 ‐ 15 0.15 ‐ 0.5 ≥ 0.5 ‐ 100

Finished  Products ‐ Solid

Parameter

Analytical  Range (%) LOQ  (%)

1 ‐ 100

1 ‐ 100

< 0.5

< 0.5

0.15

Recovery (%) 

90 ‐ 110

90 ‐ 110

≥ 50 90 ‐ 110

% RSD r % RSD R

≤ 10 ≤ 15

≤ 10 ≤ 15

≤ 20 ≤ 30

≤ 10 ≤ 15