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Silliker

Chem, Res. Center Crete, IL – Validation of a LC-MS/MS Method for Vitamin K Analysis

Silliker Laboratories, Chemistry Research Center, Date: 1/30/15

33

The powder samples were reconstituted into the liquid form and RTF samples were

analyzed as is. The results expressed as mcg/100g of vitamin K1( –trans + cis-).

6.

The method interday- precision and interaday-preision was evaluated for vitamin K

analysis in the SPIFAN samples and was found satisfactory for most of the

analyzed samples..

7.

Five SPIFAN samples (two powders and three RTF) were spiked with targeted

vitamin K compounds at three different levels.. % spike recovery of vitamin K as

folic acids ranged from 97 to 100%. All the spiked samples provided a spike

recovery within the recovery range 90-110% stipulated by the SMPR. The spike

recovery of vitamin K compounds in the SPIFAN samples was found to be

satisfactory in all of the studied SPIFAN matrices.

8.

The estimated LOQ of vitamin K1 analysis method for trans, cis and total vitamin

K1 is 0.50 µg/100g, 0.10 µg/100g and 0.60 µg/100g respectively in the

reconstituted liquid or the RTF sample. The estimated LOD of vitamin K1 analysis

method for trans, cis and total vitamin K1 is 0.15 µg/100g, 0.03 µg/100g and 0.18

µg/100g respectively

VitK-01 w/SLV

FOR ERP USE ONLY

DO NOT DISTRIBUTE