SPDS eBook March 2017

103 104

Table 1: Method performance requirements (part 1).

Ingredients (Raw Materials)

Finished Products - Solid

Finished Products – Liquid (Freeze dried samples)

Parameter

LOQ (%)

≤ 0.5

≤ 0.5

≤ 0.15

Analytical Range (%)

1 – 100

1 – 100

0.15 – 100

105 106

Table 2: Method performance requirements (part 2).

Finished Products – Liquid (Freeze dried samples)

Finished Products – Solid (1 – 100%)

Ingredients (Raw Materials) (1 – 100%)

Parameter

0.15 – 0.5%

≥ 0.5 – 100%

Recovery (%)

90 – 110

90 – 110

≥ 50

90 – 110

% RSD r

≤ 10

≤ 10

≤ 20

≤ 10

% RSD

≤ 15

≤ 15

≤ 30

≤ 15

R

107 108 109 110 111 112 113 114