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GB/T 5009.194-2003Determination of immunoglobulin in health foods (English PDF)

保健食品中免疫球蛋白lgG的测定

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

August 11, 2003

Implementation date

January 1, 2004

Scope

GB/T 5009.194-2003 is the English-translated version of 保健食品中免疫球蛋白lgG的测定.

GB/T 5009.194-2003 is the Chinese standard "Determination of immunoglobulin in health foods". Its scope clause reads: This Standard specifies the determination method of immunoglobulin IgG in health foods.

This Standard applies to determination of immunoglobulin IgG in health foods such as tablets, capsules, and powders. The detection limit of this method. When taking 0.1g of the sample; diluting it to 25 mL; and the injection volume is 20µL, the detection concentration shall be 0.5 mg / mL.

Its clauses include application scope; principle; reagents; instruments and devices; analysis steps; calculation result; precision; chromatograms. It was issued by the Ministry of Health of the People's Republic of China on MARCH 26, 2010 and took effect on JUNE 1, 2010.

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Document preview — GB/T 5009.194-2003

National Standard of the People's Republic of China

ICS
67.040
Classification
C 53

Issued by: State Administration for Market Regulation; Standardization Administration of the PRC

Contents

  • Foreword21
  • Introduction22
  • 1 Application scope23
  • 2 Principle23
  • 3 Reagents23
  • 4 Instruments and devices23
  • 5 Analysis steps23
  • 6 Calculation result24
  • 7 Precision24
  • 8 Chromatograms25

Foreword

This Standard is proposed and administered by Ministry of Health, the People's Republic of China.

This Standard is responsibly drafted by Food Hygiene Supervision and Inspection Institute of Ministry of Health. Main drafters of this standard. Yang Zuying, and Song Shufeng.

1 Application scope

This Standard specifies the determination method of immunoglobulin IgG in health foods.

This Standard applies to determination of immunoglobulin IgG in health foods such as tablets, capsules, and powders.

The detection limit of this method. When taking 0.1g of the sample; diluting it to 25 mL; and the injection volume is 20µL, the detection concentration shall be 0.5 mg / mL.

2 Principle

According to the principle of high performance affinity chromatography, under the condition of phosphate buffer, immunoglobulin IgG is connected with ligand. Under the condition of pH2.5 hydrochloric acid glycine, ELUTE the immunoglobulin IgG.

3 Reagents

3.1 Mobile phase A. pH6.5, 0.05 mol / L phosphate buffer.

3.2 Mobile phase B. pH2.5, 0.05 mol / L glycine hydrochloric acid buffer.

3.3 IgG standard stock solution. WEIGH 0.0100g of IgG standard sample (Sigma Chemical Company), USE mobile phase A (3.1) to dissolve, and SET the volume to 10.0 mL, SHAKE well, the concentration shall be 1.0 mg / mL.

4 Instruments and devices

High performance liquid chromatography instrument with UV detection and gradient elution device.

5 Analysis steps

5.1 Sample treatment. WEIGH 0.1g (accurate to 0.001 g) of sample, USE mobile phase A (3.1) to dilute to 25.0mL, SHAKE well, INJECT after it is filtered through 0.45µm microporous membrane.

5.3 HPLC reference conditions

Chromatogram column. Pharmacia HI-Trap Protein G column, 1 mL. Wavelength. 280 nm.

6 Calculation result

Calculation result shall remain two significant figures.

7 Precision

Under repeatable condition, the difference of the absolute values of two independent measurement results shall not exceed 10% of the arithmetic mean. […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.

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