SPDS eBook March 2017

SMPR of Aloe Polysaccharide Quantitation Key Points Analytical Range & Limit of Quantitation

Finished Products – Liquid  (Samples to be freeze dried  before analysis)

Finished Products ‐  Solid

Parameter Ingredients (Raw  Materials)

LOQ (%)  Analytical  Range (%) 

≤ 0.5

≤ 0.5 

≤ 0.15

1 – 100 

1 – 100 

0.15 – 100

Recovery, Repeatability & Reproducibility

Finished Products – Liquid  (Samples to be freeze dried  before analysis) 0.15 – 0.5%  ≥ 0.5 – 100%

Ingredients (Raw  Materials)  (1 – 100%)

Finished Products  – Solid  (1 – 100%)

Parameter

Recovery (%) 

90 – 110 

90 – 110 

≥ 50  ≤ 20  ≤ 30 

90 – 110

% RSD r % RSD R

≤ 10  ≤ 15 

≤ 10  ≤ 15 

≤ 10 ≤ 15

Comments Submitted

• Comment 1:  “Table 2 Recovery % is /= 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;