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YY/T 1416.2-2016 PDF English

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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
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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


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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 ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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