Prednisolone Sodium Phosphate Ophthalmic Solution
» Prednisolone Sodium Phosphate Ophthalmic Solution is a sterile solution of Prednisolone Sodium Phosphate in a buffered, aqueous medium. It contains not less than 90.0 percent and not more than 115.0 percent of the labeled amount of prednisolone phosphate (C21H29O8P), present as the disodium salt.
Packaging and storage—
Preserve in tight, light-resistant containers.
USP Reference standards 
11
—
11—
USP Prednisolone RS 
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Identification—
A: Infrared Absorption 197K
197K
Test specimen:
Place 5 mL of the Assay preparation obtained as directed in the Assay, in a glass-stoppered, 100-mL volumetric flask, mix with 5 mL of Alkaline phosphatase solution prepared as directed in the Assay, and add 50 mL of methylene chloride. Insert the stopper, and allow to stand, with occasional gentle inversion (about once every 15 minutes), for 2 hours. Filter the methylene chloride layer through a dry paper, and evaporate 25 mL of the filtrate to dryness.
Standard specimen:
Prepare as directed in Infrared Absorption 197K, using USP Prednisolone RS.
197K, using USP Prednisolone RS.
B:
Dissolve 65 mg of phenylhydrazine hydrochloride in 100 mL of dilute sulfuric acid (3 in 5), add 5 mL of isopropyl alcohol, and mix. Heat 5 mL of this solution with 1 mL of Assay preparation (obtained as directed in the Assay) at 70
for 2 hours: a yellow color develops.
for 2 hours: a yellow color develops.
Sterility 71:
meets the requirements.
71:
meets the requirements.
pH 791:
between 6.2 and 8.2.
791:
between 6.2 and 8.2.
Assay—
Proceed with Ophthalmic Solution as directed in the Assay under Prednisolone Sodium Phosphate Injection.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Mary S. Waddell
Scientific Liaison 1-301-816-8124 |
(SM42010) Monographs - Small Molecules 4 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
|
| 71 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
USP35–NF30 Page 4405