Packaging and storage—
Preserve in tight, light-resistant containers.
USP Reference standards 
11
—
USP Prochlorperazine Maleate 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—
B:
Fuse about 100 mg with a few pellets of sodium hydroxide: the cooled melt responds to the test for
Sulfite 191.
Loss on drying 731—
Dry it in vacuum at 100
for 3 hours: it loses not more than 0.5% of its weight.
Selenium 291:
0.003%, a 100-mg test specimen, mixed with 100 mg of magnesium oxide, being used.
Ordinary impurities 466—
Test solution:
a mixture of methanol and ammonium hydroxide (9:1).
Standard solution:
a mixture of methanol and ammonium hydroxide (9:1).
Eluant:
a mixture of chloroform, toluene, alcohol, and ammonium hydroxide (50:50:50:0.5).
Spray reagent—
Mix 2 mL of chloroplatinic acid solution (1 in 10) and 50 mL of potassium iodide solution (4 in 100). Dilute with water to 100 mL, and acidify with 1 N hydrochloric acid.
Visualization:
1, followed by Spray reagent.
Organic volatile impurities, Method I 467:
meets the requirements.
Assay—
Transfer about 750 mg of Prochlorperazine Edisylate, accurately weighed, to a separator containing 40 mL of water, and shake to effect solution. Render the solution alkaline with ammonium hydroxide, and extract with three 25-mL portions of ether. Wash the combined ether extracts once with about 25 mL of water, discard the washing, and evaporate the ether solution on a steam bath to dryness. Dissolve the residue in 60 mL of glacial acetic acid, add
crystal violet TS, and titrate with 0.1 N perchloric acid VS. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 28.21 mg of C
20H
24ClN
3S·C
2H
6O
6S
2.
Auxiliary Information—
Staff Liaison :
Elena Gonikberg, Ph.D., Scientist
Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
USP29–NF24 Page 1814
Pharmacopeial Forum : Volume No. 29(5) Page 1565
Phone Number : 1-301-816-8251
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