Anticoagulant Sodium Citrate Solution

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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1 DEFINITION

Anticoagulant Sodium Citrate Solution is a sterile solution of Sodium Citrate in Water for Injection. It contains, in each 100 mL, NLT 3.80 g and NMT 4.20 g of sodium citrate dihydrate (C₆H₅Na₃O₇  · 2H₂O). It contains no antimicrobial agents.

Prepare Anticoagulant Sodium Citrate Solution as follows.

[NOTE-Anhydrous sodium citrate (35.1 g) may be used instead of the dihydrate.]

Dissolve the Sodium Citrate in sufficient Water for Injection to make 1000 mL, and filter until clear. Place the solution in suitable containers, and sterilize.

2 IDENTIFICATION

A. IDENTIFICATION TESTS GENERAL, Citrate (191): Meets the requirements when evaporated to a concentration of 1 in 20

B. IDENTIFICATION TESTS-GENERAL, Sodium(191); Meets the requirements when evaporated to a concentration of 1 in 20

3 ASSAY

PROCEDURE

Mobile phase, Standard preparation 1, and Chromatographic system: Proceed as directed in Assay for Citric Acid/Citrate and Phosphate (345).

Sample solution: Pipet 10 mL of Solution into a suitable volumetric flask, and proceed as directed in Assay for Citric Acid/Citrate and

Phosphate (345), Sample solution (for the assay of citric acid/citrate).

Analysis

Samples: Standard preparation 1 and Sample solution

Proceed as directed in Assay for Citric Acid/Citrate and Phosphate (345), Procedure.

Calculate the quantity, in g, of sodium citrate dihydrate (C₆H₅Na₃O₇  · 2H₂O) in the volume of Solution taken:

Result = (r_u /r_s ) × C_s × (M_r1 /M_r2 ) × D × F

r_u = peak area of citrate from the Sample solution

r_s = peak area of citrate from Standard preparation 1

C_s = concentration of citrate in Standard preparation 1 (µg/mL)

M_r1 = molecular weight of sodium citrate dihydrate, 294.10

M_r2 = molecular weight of citrate (C₆H₅O₇), 189.10

D = dilution factor

F = conversion factor, 0.000001 g/µg

Acceptance criteria: In each 100 mL, 3.80–4.20 g of sodium citrate dihydrate (C₆H₅Na₃O₇  · 2H₂O)

4 SPECIFIC TESTS

PH (791): 6.4-7.5

BACTERIAL ENDOTOXINS TEST (85): Contains NMT 5.56 USP Endotoxin Units/mL

OTHER REQUIREMENTS: Meets the requirements in Injections and Implanted Drug Products (1)

5 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in single-dose containers, preferably of Type I or Type II glass.

USP REFERENCE STANDARDS (11)

USP Citric Acid BS