Chlorpromazine Hydrochloride Syrup
» Chlorpromazine Hydrochloride Syrup contains, in each 100 mL, not less than 190 mg and not more than 210 mg of C17H19ClN2S·HCl.
Packaging and storage—
Preserve in tight, light-resistant containers.
USP Reference standards 
11
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11—
USP Chlorpromazine Hydrochloride RS 
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[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—
A:
Transfer a volume of it, equivalent to about 20 mg of chlorpromazine hydrochloride, to a 125-mL separator. Add 10 mL of water, 2 mL of sodium hydroxide solution (1 in 2), and mix. Extract with three 30-mL portions of ether. Filter the combined ether extracts through anhydrous sodium sulfate. With the aid of a stream of nitrogen evaporate the ether to about 5 mL. Quantitatively transfer the solution to a 40-mL centrifuge tube. Evaporate with a stream of nitrogen and mild heat to dryness. Dissolve the residue in 100 mL of methanol to obtain the Test solution. Separately apply 15 µL of this Test solution and 15 µL of a Standard solution, containing 0.2 mg of USP Chlorpromazine Hydrochloride RS per mL of methanol, to a thin-layer chromatographic plate (see Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel. Develop the chromatogram in a chamber containing a freshly prepared mixture of ethyl acetate that has been saturated with ammonium hydroxide, ether, and methanol (75:25:20) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, air-dry, and spray with Iodoplatinate reagent prepared by dissolving 100 mg of platinic chloride in 10 mL of 0.1 N hydrochloric acid, adding 25 mL of potassium iodide solution (1 in 25), 0.5 mL of formic acid, and diluting with water to 100 mL: the RF value of the principal spot from the test solution corresponds to that obtained from the Standard solution.
621) coated with a 0.25-mm layer of chromatographic silica gel. Develop the chromatogram in a chamber containing a freshly prepared mixture of ethyl acetate that has been saturated with ammonium hydroxide, ether, and methanol (75:25:20) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, air-dry, and spray with Iodoplatinate reagent prepared by dissolving 100 mg of platinic chloride in 10 mL of 0.1 N hydrochloric acid, adding 25 mL of potassium iodide solution (1 in 25), 0.5 mL of formic acid, and diluting with water to 100 mL: the RF value of the principal spot from the test solution corresponds to that obtained from the Standard solution.
B:
Dilute a portion of the Syrup with an equal volume of water: the resulting solution responds to the tests for Chloride 191.
191.
Limit of chlorpromazine sulfoxide—
Chlorpromazine sulfoxide standard solution—
Transfer 5 mL of a solution in dilute hydrochloric acid (1 in 100) of USP Chlorpromazine Hydrochloride RS containing 10.6 mg per mL to a 50-mL volumetric flask. Add 2 mL of 30% hydrogen peroxide and heat at 60
for 10 minutes. Cool, dilute with 1 M sodium bisulfite to volume, and mix. Transfer 10.0 mL to a 60-mL separator, add 2 mL of sodium hydroxide solution (1 in 2), and mix. Extract with three 30-mL portions of ether. Filter the extracts through ether-wetted anhydrous sodium sulfate into a 250-mL conical flask. Cautiously evaporate the extracts to dryness. Dissolve the residue in 10.0 mL of methanol, and filter if necessary. Each mL of this solution contains 1 mg of chlorpromazine sulfoxide.
for 10 minutes. Cool, dilute with 1 M sodium bisulfite to volume, and mix. Transfer 10.0 mL to a 60-mL separator, add 2 mL of sodium hydroxide solution (1 in 2), and mix. Extract with three 30-mL portions of ether. Filter the extracts through ether-wetted anhydrous sodium sulfate into a 250-mL conical flask. Cautiously evaporate the extracts to dryness. Dissolve the residue in 10.0 mL of methanol, and filter if necessary. Each mL of this solution contains 1 mg of chlorpromazine sulfoxide.
Procedure—
Transfer an accurately measured volume of the Syrup, equivalent to about 20 mg of chlorpromazine hydrochloride, to a 125-mL separator. Add 10 mL of water and 2 mL of sodium hydroxide solution (1 in 2), and mix. Extract with three 30-mL portions of ether. Filter the combined ether extracts through anhydrous sodium sulfate. With the aid of a stream of nitrogen evaporate the ether to about 5 mL. Quantitatively transfer the solution to a 40-mL centrifuge tube. Evaporate with a stream of nitrogen and mild heat to dryness. Dissolve the residue in 1.0 mL of methanol to obtain the Test solution. Separately apply 15 µL of this Test solution and 15 µL of a Chlorpromazine sulfoxide standard solution to a thin-layer chromatographic plate (see Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel. Develop the chromatogram in a chamber containing a freshly prepared mixture of ethyl acetate that has been saturated with ammonium hydroxide, ether, and methanol (75:25:20) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, air-dry, and spray with Iodoplatinate reagent prepared by dissolving 100 mg of platinic chloride in 10 mL of 0.1 N hydrochloric acid, adding 25 mL of potassium iodide solution (1 in 25) and 0.5 mL of formic acid, and diluting with water to 100 mL. The chromatogram from the Test solution may exhibit a secondary spot whose RF value corresponds to, and whose size and intensity are not greater than, those of the spot from the Chlorpromazine sulfoxide standard solution (5.0%).
621) coated with a 0.25-mm layer of chromatographic silica gel. Develop the chromatogram in a chamber containing a freshly prepared mixture of ethyl acetate that has been saturated with ammonium hydroxide, ether, and methanol (75:25:20) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the chamber, air-dry, and spray with Iodoplatinate reagent prepared by dissolving 100 mg of platinic chloride in 10 mL of 0.1 N hydrochloric acid, adding 25 mL of potassium iodide solution (1 in 25) and 0.5 mL of formic acid, and diluting with water to 100 mL. The chromatogram from the Test solution may exhibit a secondary spot whose RF value corresponds to, and whose size and intensity are not greater than, those of the spot from the Chlorpromazine sulfoxide standard solution (5.0%).
Assay—
Transfer an accurately measured volume of Syrup, equivalent to about 10 mg of chlorpromazine hydrochloride, to a 50-mL volumetric flask, add 0.1 N hydrochloric acid to volume, and mix. Proceed as directed in the Assay under Chlorpromazine Hydrochloride Injection, beginning with “Pipet 10 mL of the solution.” Calculate the quantity, in mg, of C17H19ClN2S·HCl in each mL of the Syrup taken by the formula:
1.25C(A254 
A277)U / V(A254 A277)S
in which C is the concentration, in µg per mL, of USP Chlorpromazine Hydrochloride RS in the Standard solution; V is the volume, in mL, of Syrup taken; and the parenthetic expressions are the differences in the absorbances of the two solutions at the wavelengths indicated by the subscripts, for the solution from the Syrup (U) and the Standard solution (S), respectively.
A277)U / V(A254 A277)S
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Ravi Ravichandran, Ph.D.
Principal Scientific Liaison 1-301-816-8330 |
(SM42010) Monographs - Small Molecules 4 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 2644