Prochlorperazine Edisylate Injection
» Prochlorperazine Edisylate Injection is a sterile solution of Prochlorperazine Edisylate in Water for Injection. It contains an amount of prochlorperazine edisylate equivalent to not less than 90.0 percent and not more than 110.0 percent of the labeled amount of prochlorperazine (C20H24ClN3S).
Packaging and storage— Preserve in single-dose or in multiple-dose containers, preferably of Type I glass, protected from light.
USP Reference standards 11
USP Prochlorperazine Maleate RS
.
USP Endotoxin RS
.
note—Throughout the following procedures, protect test or assay specimens, the Reference Standard, and solutions containing them, by conducting the procedures without delay, under subdued light, or using low-actinic glassware.
Identification— It meets the requirements under Identification—Organic Nitrogenous Bases 181, USP Prochlorperazine Maleate RS being used as the standard for comparison.
Bacterial endotoxins 85 It contains not more than 17.9 USP Endotoxin Units per mg of prochlorperazine.
pH 791: between 4.2 and 6.2.
Other requirements— It meets the requirements under Injections 1.
Assay—
Phosphate buffer— Transfer about 2.68 grams of dibasic sodium phosphate, heptahydrate to a 1-L volumetric flask, add 950 mL of water, and adjust to a pH of 3.0 with phosphoric acid, dilute to volume, and mix.
Mobile phase— Prepare a filtered and degassed mixture of acetonitrile and Phosphate buffer (7:3). Make adjustments if necessary (see System Suitability under Chromatography 621).
Standard preparation— Dissolve an accurately weighed quantity of USP Prochlorperazine Maleate RS in Mobile phase, and dilute quantitatively, and stepwise if necessary, with Mobile phase to obtain a solution having a known concentration of prochlorperazine of about 0.1 mg per mL.
Assay preparation— Transfer an accurately measured portion of Injection, equivalent to about 10 mg of prochlorperazine, to a 100-mL volumetric flask, dissolve in Mobile phase, and dilute with Mobile phase to volume.
Chromatographic system (see Chromatography 621)—The liquid chromatograph is equipped with a 254-nm detector and a 3.9-mm × 30-cm column that contains packing L1. The flow rate is about 1.5 mL per minute. The column temperature is maintained at 40. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the column efficiency is not less than 3000 theoretical plates, the tailing factor is not more than 2.5, and the relative standard deviation for replicate injections is not more than 2.0%.
Procedure— Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of prochlorperazine (C20H24ClN3S) in the portion of Injection taken by the formula:
100(373.94 / 606.09)C(rU / rS)
in which 373.94 and 606.09 are the molecular weights of prochlorperazine and prochlorperazine maleate, respectively, C is the concentration, in mg per mL, of USP Prochlorperazine Maleate RS in the Standard preparation, and rU and rS are the peak responses obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Elena Gonikberg, Ph.D.
Senior Scientist
1-301-816-8251
(MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
Reference Standards Lili Wang, Technical Services Scientist
1-301-816-8129
RSTech@usp.org
85 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
1-301-816-8339
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 3396
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.