Desmopressin Acetate Injection

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

Desmopressin Acetate Injection is a sterile solution of Desmopressin Acetate in a suitable diluent. It may contain suitable preservatives. It possesses, in each mL, an activity of NLT 90.0% and NMT 110.0% of the labeled amount of desmopressin (C₄₆H₆₄N₁₄O₁₂S₂), calculated on the anhydrous, acetic acid-free basis.

2 IDENTIFICATION

A. The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.

3 ASSAY

3.1 Procedure

Buffer solution: Dissolve 4.9 g of phosphoric acid, accurately weighed, in water. Dilute with water to 1000 mL, and adjust with triethylamine to a pH of 3.5.

Solution A: Transfer 9 g of sodium chloride, accurately weighed, to a 1000-mL flask, and dissolve in and dilute with water to volume. Adjust with hydrochloric acid to a pH between 3.5 and 5.0.

Solution B: Transfer 9 g of sodium chloride, accurately weighed, to a 1000-mL flask, dissolve in water, and add 5 g of Chlorobutanol. Dilute with water to volume, and adjust with hydrochloric acid to a pH between 3.5 and 5.0.

Mobile phase: Acetonitrile and Buffer solution (16.5:83.5). Filter and degas. Make adjustments, if necessary (see Chromatography (621). System Suitability).

Sample solution: For injections with concentrations of desmopressin between 4 µg/mL and 0.1 mg/mL, use undiluted Injection. For injections with concentrations exceeding 0.1 mg/mL and without preservatives, dilute 1000 µl of Injection, accurately measured, with 10 mL of Solution A. For injections with concentrations exceeding 0.1 mg/mL and containing preservatives, dilute 1000 µL of Injection, accurately measured, with 10 mL of Solution B.

Standard solution: 1 mg/mL of USP Desmopressin Acetate RS in water. Dilute with Solution A or Solution B, as directed in Sample solution, to

obtain a solution with a concentration of desmopressin equivalent to that of the Sample solution.

Chromatographic system

• (See Chromatography (621), System Suitability.)
• Mode: LC
• Detector: UV 215 nm
• Column: 4.6-mm x 25-cm; 5-µm packing L.1
• Flow rate: 1.5 mL/min
• Injection volume: 100 µL; 50 µL for System suitability

System suitability

• Sample: Standard solution
• Suitability requirements
• Tailing factor: NMT 1.4
• Relative standard deviation: NMT 5.0% for replicate injections

Analysis

Samples: Sample solution and Standard solution

Separately inject the Sample solution and the Standard solution, both freshly prepared, and record the chromatograms for a total time of NLT 2.5 times the retention time of the desmopressin peak.

Calculate the quantity of desmopressin (C₄₆H₆₄N₁₄O₁₂S₂), in mg, in the volume of Injection taken:

Result = C × D ×  (r_u/r_s)

C = concentration of USP Desmopressin Acetate RS in the Standard solution (mg/mL)

D = dilution factor for the Sample solution

r_u = peak response from the Sample solution

r_s = peak response from the Standard solution

Acceptance criteria: 90.0%–110.0% on the anhydrous, acetic acid-free basis

4 SPECIFIC TESTS

PH (791): 3.5-6.0

BACTERIAL ENDOTOXINS TEST (85): NMT 10 USP Endotoxin Units/µg of desmopressin

STERILITY TESTS (71); It meets the requirements when tested as directed in Test for Sterility of the Product to Be Examined, Membrane Filtration.

PARTICULATE MATTER IN INJECTIONS (788): Meets the requirements for small-volume injections

OTHER REQUIREMENTS: It meets the requirements in Injections (1), Container Content.

5 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in tight containers, protected from light. Store at a temperature between 2° to 8°.

LABELING: Label it to state the potency, in mg, of desmopressin.

USP REFERENCE STANDARDS (11)

USP Desmopresain Acetate RS