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
Test method for additive in single-use containers for human venous blood specimen collection.Part 2-Sodium citrate
ICS 11.120.20
C31
People's Republic of China Pharmaceutical Industry Standard
Disposable human venous blood sample collection container added
Methods for determination of doses - Part 2. Sodium citrate
specimencolection-Part 2.Sodiumcitrate
Published on.2016-01-26
2017-01-01 Implementation
The State Food and Drug Administration issued
Foreword
YY/T 1416 "Determination of additive content in disposable venous blood sampling containers for human use" consists of the following components.
--- Part 1. ethylenediaminetetraacetic acid (EDTA) salt;
--- Part 2. Sodium citrate;
This section is Part 2 of YY/T 1416.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing agency of this document does not assume responsibility for identifying these patents.
This section was proposed by the State Food and Drug Administration.
This part is under the jurisdiction of the National Standardization Technical Committee for Medical Infusion Devices (SAC/TC106).
This section was drafted by. Shandong Provincial Medical Device Product Quality Inspection Center, BD Medical Devices (Shanghai) Co., Ltd., Shandong Xinhuaan
Medical Products Co., Ltd., Shengguang Medical Products Co., Ltd.
The main drafters of this section. Qin Yang, Zhou Xiuhua, Meng Qingsong, Qiao Xiaohong, Liu Ye.
introduction
One-time use of human venous blood sample collection containers (abbreviation. blood collection tube) is matched with one-time use of sterile venous blood sample collection needles.
Blood samples were collected for clinical testing. The use of blood collection tubes containing different additives or add-ons differs, with sodium citrate as a single use
With one of the anticoagulants used to collect blood vessels, sodium citrate can form soluble dissociative chelates with calcium ions in the blood and cause the blood to lose free calcium.
Prevent blood coagulation.
This section recommends the use of osmotic and titration methods to determine the amount of sodium citrate additive in a single blood collection tube for ease of use.
Pulse blood collection container quality control. Other methods of measurement may also be used, but methodological confirmation is required.
Disposable human venous blood sample collection container added
Methods for determination of doses - Part 2. Sodium citrate
1 Scope
This part of YY/T 1416 gives sodium citrate in the disposable human blood sample collection container (hereinafter referred to as blood collection tube).
Dosage determination method.
This section applies to the use of a non-buffered dihydrate form of sodium citrate and buffered citric acid in a disposable human blood sample collection container.
Determination of Sodium Citrate in Sodium Additives.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 6682 Analysis Laboratory Water Specifications and Test Methods
The.2010 edition of the "People's Republic of China Pharmacopoeia" 2
3 Osmotic pressure method
3.1 Test principle
The osmotic method is suitable for determining the concentration of sodium citrate in the form of unbuffered dihydrate in disposable blood collection tubes. Citric acid
The sodium standard stock solution is formulated as a series of standard solutions. Measure the osmotic pressure of each standard concentration solution using a freezing point osmometer and plot the concentration
The osmotic pressure standard curve (linear). The osmotic pressure of the sodium citrate solution in the blood collection tube is measured by the same method, or the linear regression is obtained from the standard curve.
The sodium citrate concentration corresponding to the osmotic pressure of the sample is calculated by the equation.
3.2 Instruments and reagents
3.2.1 Instruments
The main instruments include.
a) Freezing point osmometer;
b) Electronic balance with an accuracy of 0.1 mg.
3.2.2 Reagents
Unless otherwise specified, the reagents used should be analytically pure, with sodium citrate (Na3C6H5O7.2H2O), analytically pure, >99.0% pure.
Test water should meet the requirements of the secondary water specified in GB/T 6682.
3.3 Test procedure
3.3.1 Preparation of Solution Curve
Accurately weigh the appropriate amount of sodium citrate (3.2.2) and place in a 50-mL volumetric flask. Add water to dissolve and dilute to the mark. Shake well to make citric acid.
A stock solution with a sodium concentration of approximately 10% (340.02 mmol/L). Precisely measure the appropriate amount of the above solution to make sodium citrate concentration
The standard solution was 2% to 6% (68.00 mmol/L to 204.01 mmol/L). According to the.2010 edition of the "People'
Appendix IX G Osmolality Assay Measure the osmotic pressure of each standard point separately, with the concentration c (% or mmol/L) as the ordinate,
The osmotic pressure value X (mOsm/kg) is a standard curve plotted on the abscissa, and a regression equation is obtained.
3.3.2 Determination of sample solution
Take 3 blood collection samples 1), according to the.2010 edition of the "People's Republic of China Pharmacopoeia" Part II Appendix IX G osmolality assay
Measure the osmotic pressure of each tube solution separately, find out on the standard curve diagram or use the regression equation to obtain the sodium citrate concentration value of each blood collection tube.
4 Titration
4.1 Test principle
Titrate the sodium citrate content of the single blood collection tube with a known concentration of perchloric acid titrant and titrate to solution with crystal violet as indicator.
The color changes from violet to green.
4.2 Instruments and Reagents
4.2.1 Instruments
The main instruments include.
a) magnetic stirrer;
b) Electronic balance with an accuracy of 0.1mg;
c) Closed automatic burette (acid type).
4.2.2 Reagents
Unless otherwise specified, the reagents used should be analytically pure, and the test water should meet the requirements for secondary water specified in GB/T 6682. among them.
a) Glacial acetic acid. analytically pure, purity ≥99%, CAS64-19-7;
b) crystal violet. Weigh 1.0g crystal violet biological stain, add 100mL glacial acetic acid to dissolve, that is;
c) Perchloric acid titrant [c(HClO4) = 0.1mol/L]. Use commercially available certified products or press the.2010 edition of the People's Republic of China
Pharmacopoeia Part II Appendix XVF perchloric acid titrants were prepared and demarcated, placed in brown glass bottles, sealed and kept;
d) Perchloric acid titrant [c(HClO4)=0.01 mol/L]. Take 0.1mol/L perchloric acid titrant, dilute with anhydrous acetic acid
Into, and calibrate the concentration.
1) If the volume of additive in the blood collection tube is less than 0.5 mL, two tests are required after mixing.
2) The residue is golden yellow with a little white moisture and cannot be steamed to black.
4.3 Test procedure
One blood collection tube was taken, and the tube wall and the tube stopper were rinsed with a small amount of water three times. The collected washing solution was transferred to a 250 mL Erlenmeyer flask. Cone
The vial is heated until the solution has evaporated. 2) The flask is placed in a desiccator until it is completely cooled. Immediately after cooling, add 50mL glacial acetic acid again
Dissolve the residue in the Erlenmeyer flask and add 2 drops of crystal violet indicator. Stir the Erlenmeyer flask on a magnetic stirrer and titrate it with perchloric acid.
The solution to the bright green, which is the end point, records the volume V of the titrant used, as well as a blank control. Calculate the additive lemon in blood collection tube according to formula (1)
Sodium content. Take another blood collection tube and repeat the above procedure.
m=
Cs
(V-V0)×f (1)
In the formula.
m --- sodium citrate additive in blood vessels, in milligrams (mg);
Cs --- The actual concentration of perchloric acid titrant, in moles per liter (mol/L);
c --- Perchloric acid titrant concentration in moles per liter (mol/L);
V --- The volume of perchloric acid titrant used to titrate the sample in milliliters (mL);
V0 --- the volume of the perchloric acid titrant used to titrate the blank, in milliliters (mL);
f --- titration factor, the amount of trisodium citrate corresponding to 1 mL of titrant, and the f value of Na3C6H5O7·2H2O is 0.9803.
5 Test report
The test report should include at least the following.
a) Identification of test samples;
b) the number of this section;
c) test results;
d) test date;
e) Test personnel.