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YY/T 1416.2-2016 English PDF (YYT1416.2-2016)

YY/T 1416.2-2016 English PDF (YYT1416.2-2016)

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

This Part of YY/T 1416 specifies the method for determining the amount of additive "sodium citrate" in single-use containers for human venous blood specimen collection. This Part applies to the determination of the sodium citrate in the form of non-buffered dihydrate in single-use containers for human venous blood specimen collection and the determination of the sodium citrate in buffered sodium-citrate additive.
YY/T 1416.2-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.120.20
C 31
Test method for additive in single use containers
for human venous blood specimen collection ?€?
Part 2. Sodium citrate
ISSUED ON. JANUARY 26, 2016
IMPLEMENTED ON. JANUARY 1, 2017
Issued by. China Food and Drug Administration
Table of Contents
Foreword . 3
Introduction .. 4
1 Scope .. 5
2 Normative references . 5
3 Osmotic pressure method .. 5
4 Titration method . 7
5 Test report . 8
Test method for additive in single use containers
for human venous blood specimen collection ?€?
Part 2. Sodium citrate
1 Scope
This Part of YY/T 1416 specifies the method for determining the amount of additive ?€?sodium citrate?€? in single-use containers for human venous blood specimen collection (hereafter referred to as blood-collecting vessel).
This Part applies to the determination of the sodium citrate in the form of non-buffered dihydrate in single-use containers for human venous blood specimen collection and the determination of the sodium citrate in buffered sodium-citrate additive. 2 Normative references
The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this standard.
GB/T 6682 Water for analytical laboratory use - Specification and test methods Pharmacopoeia of the People's Republic of China (2010) - Volume II
3 Osmotic pressure method
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.
3.2 Instruments and reagents
4 Titration method
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

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