YY/T 1416.1-2016Test method for additive in single-use containers for human venous blood specimen collection - Part 1: Ethylene diamine tetraacetic acid (EDTA) salt (English PDF)

3.1 Test principle

Prepare a series of standard solutions with EDTA salt standard reserve solution.

Measure the osmotic pressure of each standard concentration solution by freezing point osmosimeter. Draw a standard curve (linear) of the osmotic pressure. Measure by the same method the osmotic pressure of EDTA salt solution in the blood collection tube where the nominal capacity is reached by adding water. Find from the standard curve or calculate by linear regression equation the concentration of ethylene diamine tetraacetic acid (EDTA) salt corresponding to the osmotic pressure of the sample.

3.2 Instruments and reagents

3.2.1 Instrument

Instruments for osmotic pressure method include.

a) Freezing point osmometer;

b) Electronic balance with precision of 0.1mg.

3.2.2 Reagent

Unless otherwise specified, the reagent used shall be analytical pure, and the water used shall conform to the requirements of the 2nd class water specified in GB/T 6682, of which.

a) Ethylene diamine tetraacetic acid disodium dishydrate (EDTA-Na2·2H2O). analytical purity>=99.0%;

b) Ethylene diamine tetraacetic acid dipotassium dihydrate (EDTA- K2·2H2O). analytical purity>=99.0%;

c) Anhydrous ethylene diamine tetraacetic acid tripotassium (EDTA-K3). analytical purity>=99.0%.

3.3 Test steps

3.3.1 Drawing of standard curve

Accurately weigh appropriate amount of ethylene diamine tetraacetic acid (EDTA) salt [a), b) or c) in 3.2.2] corresponding to the additive to be tested in single-use blood collection tube. Add water to dissolve and dilute to a mass concentration of EDTA salt at about 10 mg/mL. Thus, the standard reserve solution is prepared. Accurately measure appropriate amount of the reserve solution respectively. Add water to dilute to a series of standard solution with the concentration of EDTA salt at 0.5mg/ mL~4.0 mg/mL. Determine the osmotic pressure of each concentration solution according to the method of the osmotic pressure molar concentration specified in the second part IX G of the Pharmacopoeia of the People's Republic of China 2010 edition. Draw a standard curve with the concentration C (mg/mL) as ordinate and the osmotic pressure value X (mOsm/kg) as abscissa. Also make the regression equation.

3.3.2 Determination of sample solution

Take 3 EDTA blood collectors, add water of nominal volume with precision, shake fully until anticoagulant is dissolved. Respectively determine the osmotic pressure of the 3 EDTA blood collectors by the method of osmotic pressure specified in the second part IX G of the Pharmacopoeia of the People's Republic of China. Find on the standard curve or calculate by regression