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Method Reference #

Method title:

Principle of the method:

Parameter

Method Performance

Please report

in units as stated in SMPR!

Suitability

Ranking (1-3-5)

(select from drop-

down list, 5 = best)

SPIFAN matrices

Applicable to all forms of infant, adult, and/or pediatric formula (powders,

ready-to-feed liquids, and liquid concentrates).

Combination of milk, soy, hydrolyzed protein, FOS/GOS, amino acids, with high

or low fat.

All SPIFAN matrices analyzed for repeatability.

Representative matrices from each category analyzed for

recovery during SLV, except for Infant RTF due to the

defficient sample amount.

All required analytes are

measured.

Biotin

Method measures all required analytes.

0.1-150 mcg/100g reconstituted final product

1.66-142 mcg/100g reconstituted final product

Biotin

Not Applicable

Biotin

d

0.1 mcg/100g reconstituted final product

~0.8 mcg/100g in reconsitituted powder product OR

~1.5 mcg/100 g in ready-to-feed product

See Table 1

0.1-1 mcg/100g reconstituted final product: 80-120%

Not Applicable

>1 mcg/100g recons tituted final product: 90-110%

Range: 95-111% See Table 2

Bias vs SRM

See Table 3

0.1-1 mcg/100g reconstituted final product :

d

%

Not Applicable

>1 mcg/100g reconstituted final product :

d

6%

Range: 0.5-3.0% See Table 4

No SMRP requirements

Range: 1.3-4.5% See Table 4

0.1-1 mcg/100g reconstituted final product :

d

%

>1 mcg/100g reconstituted final product :

d

%

Suitable methods will include blank check samples, and check standards at the

lowest point and midrange point of the analytical range.

90-110% recovery of SRM with different sample sizes and

being quantified withing the calibration curve range of

8.5-60 ng/mL. See Table 5

Analytical equipment

Proprietary equipment

Laboratory safety

Other Considerations

Overall Score

0

Decision by ERP

Recommendation

ERP 2 years after

First Action Status

move to Final Action/repeal/remove/expand 2 year term

Notes

a

Concentrations apply to (1)

"ready to feed liquids" "as-is"; (2)

reconstituted powders (25 g into

200 g water); and (3) liquid

concentrates diluted 1:1 by weight.

b

Units

Feedback from Users of the Method since being

awarded First Action

Official Methods

Status

Adequate proof of performance via system suitability

Spike recovery

Accuracy/Recovery

Reproducibility (RSDR)

Intermediate Reproducibility

(RSDiR)

Evaluation of Method Performance vs. SMPR requirements.

Determination of biotin in infant, pediatric and adult nutritionals by HPLC and fluorescence detection

This reverse phase HPLC method with post column reduction and fluorescence detection allows for the quantitative determination of biotin in infant, pediatric, and adult nutritionals. Sample of

appropriate size is mixed with 6% meta-phosphoric acid to precipitate out the protein to produce a filtrate. The filtrate is injected onto a C18 HPLC column where biotin and riboflavin are separated

with a mobile phase (20% methanol in 0.02 M phosphate buffer at pH7.0). The biotin after eluting from the column binds with the streptavidin fluorescein to become a fluorescent conjugate. The

conjugate is then detected by fluorescence at an excitation wavelength of 495 nm and an emission wavelength of 518 nm.

Repeatability (RSDr)

SMPR Requirement

Analytical Range

Limit of detection (LOD)

Limit of detection (LOQ)

Did Method Author Consider ERP’s Method Specific

Recommendations

(See web link to specific method

comments):

Analytical equipment is commonly available in most labs.

No unique proprietary equipment/accessories are required.

hod does not require any special safety precautions e.g. personal protection from highly toxic solve

SPIFAN ERP Checklist v 1.0

Bio-03 (February 2016)

FOR ERP USE ONLY

DO NOT DISTRIBUTE