Cloprostenol Sodium

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

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

DOWNLOAD PDF HERE

C₂₂H₂₈CINaO₆        446.90

5-Heptenoic acid, 7-[2-[4-(3-chlorophenoxy)-3-hydroxy-1-butenyl]-3,5-dihydroxycyclopentyl]-, [1a(Z),28(1E,3R*), 30,5a]-, sodium salt, (+)-; (±)-Sodium (Z)-7-[(1R*,2R,3R*,5S*)-2-((E)-(3R*)-4-(m-chlorophenoxy)-3-hydroxy-1-butenyl]-3,5-dihydroxycyclopentyl]-5-heptenoate CAS RN: 55028-72-3; UNII: 886SAV9675.

1 DEFINITION

Cloprostenol Sodium contains NLT 97.5% and NMT 102.5% of cloprostenol sodium (C₂₂H₂₈CINaO₆), calculated on the anhydrous basis.

2 IDENTIFICATION

Change to read:

A. ^▲SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197K _{▲(CN 1-MAY-2020)}

B. IDENTIFICATION TESTS GENERAL, Sodium (191)

3 ASSAY

3.1 PROCEDURE

Mobile phase: Chromatographic hexane, dehydrated alcohol, and glacial acetic acid (900:100:1) 

Standard solution: 0.8 mg/mL of USP Cloprostenol Sodium RS in dehydrated alcohol

Sample solution: 0.8 mg/mL of Cloprostenol Sodium in dehydrated alcohol

3.1.1 Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 220 nm

Column: 4.6-mm x 25-cm; 5-µm packing L3

Flow rate: 1.8 mL/min

Injection volume: 5 µL

3.1.2 System suitability

Sample: Standard solution

3.1.3 Suitability requirements

Tailing factor: NMT 1.5 for the cloprostenol peak

Relative standard deviation: NMT 2.0%

3.1.4 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of cloprostenol sodium (C₂₂H₂₈CINaO₆) in the portion of Cloprostenol Sodium taken:

                 Result = (r_U/r_S) x (C_S/C_U) × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Cloprostenol Sodium RS in the Standard solution (mg/mL)

C_U = concentration of Cloprostenol Sodium in the Sample solution (mg/mL)

Acceptance criteria: 97.5%-102.5% on the anhydrous basis

4 IMPURITIES

4.1 ORGANIC IMPURITIES

Mobile phase: Chromatographic hexane, dehydrated alcohol, and glacial acetic acid (930:70:1)

Sample solution: 20 mg/mL of Cloprostenol Sodium in dehydrated alcohol

Standard solution, Chromatographic system, and System suitability: Proceed as directed in the Assay, except use a run time of NLT 2 times the retention time of cloprostenol.

4.1.1 Analysis

Sample: Sample solution

Calculate the percentage of each impurity in the portion of Cloprostenol Sodium taken:

                           Result = (r_U/r_T) x 100

r_U = peak response of each individual impurity from the Sample solution

r_T = sum of the responses all the peaks from the Sample solution

Acceptance criteria: Disregard any peak below 0.05%.

Individual impurities: NMT 1.0%

Total impurities: NMT 2.5%

5 SPECIFIC TESTS

WATER DETERMINATION, Method/(921)

Sample solution: 50 mg dissolved in 1 mL of dehydrated alcohol

Acceptance criteria: NMT 3.0%

6 ADDITIONAL REQUIREMENTS

LABELING: Label it to indicate that it is for veterinary use only.

PACKAGING AND STORAGE: Preserve in tight, light-resistant containers.

USP REFERENCE STANDARDS (11)

USP Cloprostenol Sodium RS