Amino Acids SMPR- August 25, 2018

L-isoleucine

(2S,3S)-2-amino-3-methylpentanoic acid (2S)-2-amino-4-methylpentanoic acid

73-32-5 61-90-5 56-87-1 63-68-3 63-91-2 147-85-3 56-45-1 72-19-5 73-22-3 60-18-4 72-18-4 107-35-7

L-leucine

L-lysine

(2S)-2,6-diaminohexanoic acid

L-methionine L-phenylalanine

(2S)-2-amino-4-methylsulfanylbutanoic acid (2S)-2-amino-3-phenylpropanoic acid (2S)-pyrrolidine-2-carboxylic acid (2S)-2-amino-3-hydroxypropanoic acid (2S,3R)-2-amino-3-hydroxybutanoic acid (2S)-2-amino-3-(1H-indol-3-yl)propanoic acid (2S)-2-amino-3-(4-hydroxyphenyl)propanoic acid

L-proline L-serine

L-threonine L-tryptophan

L-tyrosine

L-valine taurine

(2S)-2-amino-3-methylbutanoic acid

2-aminoethanesulfonic acid

a Determined only as free amino acids. b Not reported separately when acid hydrolysis is used. c Generally not reported separately.

82 83 84

4. Method Performance Requirements:

0.5-2500*

Analytical range

Limit of Quantitation (LOQ)

≤ 0.5*

Recovery

0.5 – 5.0* 5.0 – 150 150 – 2500 0.5 – 5.0* 5.0 – 150 150 – 2500 0.5 – 5.0* 5.0 – 150 150 – 2500

± 12% + 10%

+ 7%

Repeatability (RSD r )

≤ 7 % ≤ 5 % ≤ 3 %

Reproducibility (RSD R )

≤ 11 %

≤ 8 % ≤ 5 %