Lypressin Nasal Solution
» Lypressin Nasal Solution is a solution, in a suitable diluent, of the polypeptide hormone, prepared synthetically and free from foreign proteins, which has the properties of causing the contraction of vascular and other smooth muscle and of producing antidiuresis, and which is present in the posterior lobe of the pituitary of healthy pigs. It contains suitable preservatives, and is packaged in a form suitable for nasal administration so that the required dosage can be controlled as required. Each mL of Lypressin Nasal Solution possesses a pressor activity of not less than 85.0 percent and not more than 120.0 percent of that stated on the label in USP Posterior Pituitary Units.
Packaging and storage— Preserve in containers suitable for administering the contents by spraying into the nasal cavities in a controlled individualized dosage.
USP Reference standards 11
USP Vasopressin RS Click to View Structure
Labeling— Label it to indicate that it is for intranasal administration only. Label it also to state that the package insert should be consulted for instructions to regulate the dosage according to symptoms.
pH 791: between 3.0 and 4.3.
Limit of oxytocic activity— Proceed with Nasal Solution as directed in the test for Oxytocic activity under Vasopressin.
Assay— Proceed with Nasal Solution as directed in the Assay under Vasopressin Injection.
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Monograph Thomas A. Sigambris, M.S.
Scientific Liaison
(BIO12010) Monographs - Biologics and Biotechnology 1
Reference Standards RS Technical Services
USP35–NF30 Page 3732
Pharmacopeial Forum: Volume No. 30(3) Page 893