YY/T 1416.2-2016Test method for additive in single-use containers for human venous blood specimen collection - Part 2: Sodium citrate (English PDF)

3.1 Test principle

The osmotic pressure method is suitable for the determination of the concentration of the sodium citrate in the form of non-buffered dihydrate in single-use blood-collecting vessel. Use the sodium-citrate standard stock solution to prepare a series of standard solutions. Use the freezing point osmometer to measure the osmotic-pressure value of each standard-concentration solution; draw the standard curve (linear) between the concentration and the osmotic pressure. Use the same method to measure the osmotic pressure of the sodium citrate solution in blood-collecting vessel. Use the standard curve to look up or use the linear regression equation to calculate the sodium-citrate's concentration corresponding to the osmotic pressure of the sample.

4.1 Test principle

Use the perchloric acid titrant whose concentration is known to titrate the content of sodium citrate in each blood-collecting vessel; use crystal violet as the indicator; titrate it until the color of the solution changes from violet to green.

4.2 Instruments and Reagents

4.2.1 Instruments

Main instruments include.

a) Magnetic stirrer;

b) Electronic balance with the accuracy of 0. 1 mg;

c) Closed automatic burette (acid).

4.2.2 Reagents

Unless otherwise specified, the reagents used should be the analytically pure. The test water shall meet the requirements for Grade-2 water specified in GB/T 6682. Wherein.

a) Glacial acetic acid. analytically pure. The purity shall be >= 99%, CAS 64-19-7;

b) Crystal violet. weigh 1.0 g of biological stain "crystal violet"; add 100 mL of glacial acetic acid to dissolve it; that is the crystal violet;

c) Perchloric acid titrant [c(HClO4) = 0.1 mol/L]. use the commercially available certified product; or it can be prepared or calibrated by the "VF perchloric acid titrant" in Appendix X of the "Pharmacopoeia of the People's Republic of China (2010) - Volume II"; place it in the brown glass bottle; keep it sealed.

d) Perchloric acid titrant [c(HClO4) = 0.1 mol/L]. take 0.1 mol/L perchloric acid titrant; prepare it by diluting it with the anhydrous acetic acid; and calibrate its concentration.

4.3 Test procedures

Take 1 blood-collecting vessel; use a small amount of water to rinse the vessel's wall and plug, for 3 times separately; collect all the rinsed solution and transfer it to a erlenmeyer flask of 250 mL. Heat the erlenmeyer flask until the solution is evaporated