Review Team (February 2016)

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

Validation Report No. : BLR/PS-FRL/VAL/XXX

Product Parameter

Infant Formula, Dietary Supplements, Fruit juices

B-complex vitamins

SOP No.

LAB_P_SOP_272

Date of Analysis

01.01.2015

Equipment - Sample Preparation

Electronic Balance

BLR/PS-CLF/007.02

Vortex Homogenizer Refrigerated Centrifuge

BLR/PS-CLF/005.02 BLR/FCL/010.02

pH meter

Equipment - Screening/Quantification

LC-MS/MS-Agilent -6460C

LC-MS/MS 6460A (BLR/PS-CRS/006.03)

Chemicals

Name- Grade & Brand Ascorbic acid- AR grade- Merck Milli-Q water Ammonia, AR grade - Merck Formic acid, MS grade Ammonium Formate, MS grade

Reference Material -Preparation

Sample Preparation Weight of Sample

0.25 g 50.0 ml 1.0 ml 1.0 ml

Volume made Aliquot Taken Final Dilution

Validation Plan Criteria

Refer Page No. 3 and 4

Conclusion

Validation is performed as per AOAC - SPIFAN guidelines to verify the method for its performance. Method is found to be suitable to perform the B-complex vitamins in Infant Formulas and Dietary Supplements.

Performed by

Manjunath K

Reviewed by Sign & Date Approved by Sign & Date

BKVR Prasad

M.Meena

GM-Chemical Testing

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