2019 Vet Drug Residues ERP - Review Book

AOAC SMPR ERPs - 2019 METHOD REVIEW FORM

Submission Date

2019-09-06 16:35:28

Name

Sherri Turnipseed

E-mail

sherri.turnipseed@fda.hhs.gov

Organization

US FDA

Title of Method

Veterinary Drug Residues

AOAC Candidate Method Number (e.g. ALN-01)

VD4S154

Applicable SMPR

2018.010

I. Summary of the Method

The submission describes and documents a suite of methods to screen for 154 veterinary drug residues in milk and meat products There are four different analytical methods (defined as "streams") that would be performed for each sample to cover many the veterinary drug residues specified in the SMPR The four methods are divided by drug class with the first method "Stream A" incorporating the majority (107) of the veterinary drugs covered by the submission including the major drug classes of sulfonamides, quinolones, macrolides, avermectins, benzimidazoles and several others. The sample cleanup is divided into two portions, one for the avermectins and one for the remaining analytes. Stream B method includes 23 β -lactam (penicillin and cephalosporin) analytes. Stream C method is for the very polar aminoglycoside analytes (N=14). Stream D method is designed for the 5 major tetracycline residues and their related epimers. Other Comments: • The methods use a relatively large volumes of buffer or acetonitrile for extraction (20-45 mL). • The documentation regarding the different choices for QuEChERS salts and standard mixes (preparing manually and/or purchasing pre-made kits from manufacturers) is very helpful. This not only demonstrates method ruggedness but also allows for flexibility in implementation.