Dinoprostone
(dye'' noe pros' tone).
C20H32O5 352.47 Prosta-5,13-dien-1-oic acid, 11,15-dihydroxy-9-oxo-, (5Z,11,13E,15S)-; (E,Z)-(1R,2R,3R)-7-[3-Hydroxy-2-[(3S)-(3-hydroxy-1-octenyl)]-5-oxocyclopentyl]-5-heptenoic acid; Prostaglandin E2 [363-24-6]. DEFINITION
Dinoprostone contains NLT 97.0% and NMT 103.0% of C20H32O5.
[NotePrepare all solutions in all tests immediately before use. ]
IDENTIFICATION
• B.
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
ASSAY
• Procedure
Mobile phase:
Methanol and 0.2% acetic acid (29:21)
Standard solution:
2.5 mg/mL of USP Dinoprostone RS in Mobile phase
Sample solution:
2.5 mg/mL of Dinoprostone in Mobile phase
Chromatographic system
Mode:
LC
Detector:
UV 210 nm
Column:
4.6-mm × 25-cm; packing L1
Temperature:
30
Flow rate:
1 mL/min
Injection size:
20 µL
System suitability
Sample:
Standard solution
Suitability requirements
Resolution:
NLT 1.0 between dinoprostone and any other adjacent peak
Relative standard deviation:
NMT 2.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of C20H32O5 in the portion of Dinoprostone taken:
Result = (rU/rS) × (CS/CU) × 100
Acceptance criteria:
97.0%103.0%
IMPURITIES
Inorganic Impurities
• Residue on Ignition 281:
NMT 0.5%
Organic Impurities
• Procedure
Mobile phase:
Proceed as directed in the Assay.
Standard stock solution:
Prepare as directed for the Standard solution in the Assay.
Standard solution:
Transfer 0.5 mL of the Standard stock solution to a 50-mL volumetric flask, and dilute with Mobile phase to volume.
Sample solution:
Prepare as directed in the Assay.
Chromatographic system
Mode:
LC
Detector:
UV 210 nm
Column:
4.6-mm × 25-cm; packing L1
Temperature:
30
Flow rate:
1 mL/min
Injection size:
20 µL
System suitability
Samples:
Standard stock solution and Sample solution
Suitability requirements
Column efficiency:
NLT 6000 theoretical plates, Standard stock solution
Relative standard deviation:
NMT 2.0%, Standard stock solution
Resolution:
NLT 1.0 between dinoprostone and any other adjacent peak, Sample solution
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of each impurity in the portion of Dinoprostone taken:
Result = (rU/rS) × (CS/CU) × (1/F) × 100
Acceptance criteria:
See Impurity Table 1.
Impurity Table 1
SPECIFIC TESTS
• Optical Rotation, Specific Rotation 781S:
82.0 to 90.0, at 20
Sample solution:
5 mg/mL, in alcohol
• Water Determination, Method I 921:
NMT 0.5%
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed, light-resistant containers.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 2929
Pharmacopeial Forum: Volume No. 35(5) Page 1132
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