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
YY/T 1416.2-2016
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S 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