Review Team (February 2016)

Bio-03 (February 2016) FOR ERP USE ONLY DO NOT DISTRIBUTE

Table 5

System Suitability

Reference value

HPLC-Injected Sample Conc. (ng/mL)

Measured value a Conc. (mg/kg pwd)

Calibration Standard

Recovery vs CoA

SRM Product

Code

Analyte

Sample size

Suitable range

(%) 109 114 106 101 103 97.2 96.0 87.1 87.0

(mg/kg pwd)

(g)

Level Blank

Conc. (ng/mL)

Conc. (ng/mL)

0.1445 0.1532 0.2006 1.0020 1.0006 1.5177 1.5082 2.0006 2.0003

6.276 6.981 8.454 40.21 41.05 58.69 57.60 69.39 69.28

2.172 2.278 2.107 2.006 2.051 1.934 1.910 1.734 1.732

0

1 2 3 4 5 6 7

4.981 9.962 19.92 39.85 59.77 79.70 99.62

1849a

CLC-10b

Biotin

1.99

8.45-58.7

a. Results reported as mg/kg powder to be consistant with COA.

SPIFAN ERP Checklist v1.0