Desmopressin Nasal Spray Solution
» Desmopressin Nasal Spray Solution is a solution of Desmopressin Acetate in a suitable diluent. It is supplied in a form suitable for nasal administration and contains suitable preservatives. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of desmopressin (C46H64N14O12S2), calculated on the anhydrous, acetic acid-free basis.
Packaging and storage— Preserve in containers suitable for administering the contents by spraying into the nasal cavities in a controlled, individualized dosage. Protect from light, and store at a temperature between 2 and 8.
Labeling— Label it to indicate that it is for intranasal administration only and to state the total number of discharges. Label it also to state that the dosage regulation is described in the package insert.
USP Reference standards 11
USP Desmopressin Acetate RS Click to View Structure
Identification— The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Microbial enumeration tests 61 and Tests for specified microorganisms 62 The total aerobic microbial count does not exceed 100 cfu per mL, the total combined molds and yeasts count does not exceed 10 cfu per mL, and it meets the requirements of the test for the absence of Staphylococcus aureus and Pseudomonas aeruginosa.
pH 791: between 3.5 and 6.0.
Uniformity of unit spray weight and total number of discharges per container— Select three Nasal Spray Solution units, and prime each spray pump as directed on the label, but not more than five times. Accurately weigh, by difference, 10 individual deliveries from each unit, weighing the first 3 discharges immediately after priming, weighing 4 discharges from the middle of each unit, and 3 close to the end of each unit. Continue to fire until the unit is empty. For each unit, determine the total number of discharges, including the number of priming deliveries, and calculate the mean weight delivered per discharge: it contains not less than the number of discharges stated on the label; the mean weight delivered per discharge is within 10% of the labeled weight per discharge; and not fewer than 9 tested discharges for each unit are between 85% and 125% of the labeled weight per discharge.
Buffer solution, Mobile phase, Solution A, Solution B, and Chromatographic system— Prepare as directed in the Assay under Desmopressin Injection.
Assay preparation, Standard preparation, and Procedure— Proceed as directed for products containing preservatives in the Assay under Desmopressin Injection.
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USP35–NF30 Page 2830
Pharmacopeial Forum: Volume No. 31(4) Page 1059