Review Team (February 2016)

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

Table 5. Suitable range of sample concentration after dilution.

HPLC- Injected Sample Conc. (ng/mL)

SRM Product

Reference value (mg/kg powder)

Sample size

Measured value (mg/kg powder)

Recovery vs CoA

Calibration Standard

Suitable range Conc. (ng/mL)

Code

Conc. (ng/mL)

(g)

(%)

Level

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

109 114 106 101 103 97.2 96.0 87.1 87.0

Blank

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

1.99

8.5 – 60

Table 4. A representative calibration standard data.

Concentration (ng/mL)

Amount (ng/mL)

Level

HPLC Peak area

Error

1 2 3 4 5 6 7

5

0.2019 0.6600 2.2932 6.1743 9.2305 11.353 12.863

6.21 9.00

24% 10%

10 20 40 60 80

18.61 41.03 60.45 77.66 103.9

7% 3% 1% 3% 4%

100

Figure 1. A representative calibration curve.