Method Needs and Fitness for Purpose Statement

 

Date: September 19, 2004

 

Project: Determination of Lasalocid sodium in animal feeding stuffs

 

Project Leader:          Charles Focht

                                    Nebraska Department of Agriculture Laboratory

                                    Lincoln NE 68502

                                    Tel: (402) 271-2176

                                    Fax: (402) 271-0091

                                    Email: charlesf@agr.state.ne.us

Project Team:

 

1.0 Needs:

   Lasalocid sodium is used as an aid in the prevention of coccidiosis in broiler chickens, growing turkeys, and calves (fed in confinement), for improved feed efficiency and increased rate of weight gain in beef cattle (fed in confinement for slaughter), and for increased rate of weight gain in pasture cattle.  Methodology is required to verify the levels of lasalocid in various feeds, supplements and premixes.  Methodology is also required to determine contamination levels to verify clean out of manufacturing equipment (cross contamination).  Lasalocid should not be fed to lactating cows, and may be fatal when ingested by horses and other equines.

 

1.1 Performance Needs (based on laboratory sample)

Accuracy: (See Recovery)

Type A & Type B Medicated/Additive/Premix/Mineral Mix, 95 – 105%,

Type C Medicated Feed, 90 – 110 %

            Contamination, > 80%

Applicability:

            For use in chicken broiler, turkey and cattle/calf feeds

Premixes:  150 g//kg

            Medicated/Additive Complete Feed for broiler chickens: 105 mg/kg

Medicated/Additive Complete Feed for growing turkeys:  100 mg/kg

Medicated/Additive Complete Feed for beef cattle:  36 mg/kg

Medicated/Additive Complete Feed for calves: 36 mg/kg

Supplement Medicated Mineral Feeds for pasture cattle:  400 to 1600 mg/kg

Supplement Feed/Lick Blocks: 200 mg/kg

Detection Limits: 

            Medicated/Additive/Premix/Mineral Mix   3 mg/kg

            Contamination: 0.3 mg/kg

Determination Limits:

            Medicated/Additive/Premix/Mineral Mix   10 mg/kg

            Contamination: 1.0 mg/kg

Precision Repeatability:

            Medicated/Additive/Premix/Mineral Mix: CVr = or < 5 %

            Contamination: CVr = or < 10 %.

Precision Reproducibility

Medicated/Additive/Premix/Mineral Mix: CVR = or < 10 %

            Contamination: CVR = or < 20 %.

Range: 1.0 mg/kg to 150 g/kg

Recovery:

Medicated/Additive/Premixes/Mineral Mixes 95 – 105 %

Contamination >80%

 

Selectivity:

            The method is to be free of interferences from matrix, other drugs, vitamins, minerals.  Lasalocid is compatible with the following drug/drug combinations: 3-nitro-4-hydroxyphenylarsonic acid (broiler chickens), lincomycin (broiler chickens), melengestrol acetate (beef heifers), virginiamycin (broiler chickens).

            Lasalocid contains five biologically active homologs in sufficient proportions.  Methodology is to consider these homologs and account for their contributions to the activity.

 

Linearity of standard curve:  r ≥ 0.999 for major homologue, and 95% confidence limit of the y intercept includes zero.

 

Special Considerations:

            Performance of this method should be comparable to or exceed plate assay AOACI OMA 975.60 and spectrofluorometric AOACI OMA 975.61 methods.

                        The method is to be rugged/robust and critical parameters are to be identified and controlled.

            Method performance criteria are to be defined and suggestions for validation to demonstrate ability to meet these criteria (capable of performing method).

            Quality control plan is to be suggested along with warning and out of control limits.

Traceability:

            Standards and acceptable sources are to be identified.  Standards are to provide activities and uncertainty.

 

Method Performance: 

 

Fitness for Purpose Review

 

Fitness for Purpose Statement