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SMPR of Aloe Polysaccharide
Quantitation Key Points
Analytical Range & Limit of Quantitation
Recovery, Repeatability & Reproducibility
Parameter Ingredients (Raw
Materials)
Finished Products ‐
Solid
Finished Products – Liquid
(Samples to be freeze dried
before analysis)
LOQ (%)
≤ 0.5
≤ 0.5
≤ 0.15
Analytical
Range (%)
1 – 100
1 – 100
0.15 – 100
Parameter
Ingredients (Raw
Materials)
(1 – 100%)
Finished Products
– Solid
(1 – 100%)
Finished Products – Liquid
(Samples to be freeze dried
before analysis)
0.15 – 0.5%
≥ 0.5 – 100%
Recovery (%)
90 – 110
90 – 110
≥ 50
90 – 110
% RSD
r
≤ 10
≤ 10
≤ 20
≤ 10
% RSD
R
≤ 15
≤ 15
≤ 30
≤ 15
Comments Submitted
•
Comment 1:
“Table 2 Recovery % is </= 50% for sample
0.15% ‐ 0.5%. This would seem to want low recoveries.”;
•
Proposed Change:
This should be >/= 50%;
•
Comment 2:
“Tables 1 & 2: in the far right column of each
table, under "liquid samples" the text "(Freeze‐dried
samples)". Does this include only freeze‐dried samples, or
is this just an example? some clarification might be
useful.”;
•
Proposed Change:
(Sample to be freeze dried before
analysis);
•
Other typos are corrected accordingly;