Methamphetamine Hydrochloride
(meth'' am fet' a meen hye'' droe klor' ide).
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C10H15N·HCl 185.70

Benzeneethanamine, N, -dimethyl-, hydrochloride, (S)-.
(+)-(S)-N, -Dimethylphenethylamine hydrochloride [51-57-0].
» Methamphetamine Hydrochloride contains not less than 98.5 percent and not more than 100.5 percent of C10H15N·HCl, calculated on the dried basis.
Packaging and storage— Preserve in tight, light-resistant containers.
USP Reference standards 11
USP Methamphetamine Hydrochloride RS Click to View Structure
Identification—
B: It responds to the tests for Chloride 191.
Melting range 741: between 171 and 175.
Specific rotation 781S: between +16 and +19.
Test solution: 20 mg per mL, in water.
Loss on drying 731 Dry it at 105 for 2 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281: not more than 0.1%.
Ordinary impurities 466
Test solution: chloroform.
Standard solution: chloroform.
Eluant: a mixture of chloroform, cyclohexane, and diethylamine (5:4:1).
Visualization: 1.
Assay—
Mobile phase— Prepare a degassed solution of 1.1 g of sodium 1-heptanesulfonate in a mixture of water, methanol, and diluted glacial acetic acid (7 in 50) (575:400:25). Adjust with the addition of acetic acid to a pH of 3.3 ± 0.1, if necessary. Filter through a 0.5-µm disk. Make adjustments if necessary (see System Suitability under Chromatography 621).
Standard preparation— Dissolve an accurately weighed quantity of USP Methamphetamine Hydrochloride RS in 0.12 M phosphoric acid, and dilute quantitatively and stepwise, with the aid of sonication if necessary, with 0.12 M phosphoric acid to obtain a solution having a known concentration of about 0.2 mg per mL.
Assay preparation— Transfer about 20 mg of Methamphetamine Hydrochloride, accurately weighed, to a 100-mL volumetric flask, dissolve in and dilute with 0.12 M phosphoric acid to volume, and mix.
Chromatographic system (see Chromatography 621)—The liquid chromatograph is equipped with a 257-nm detector and a 3.9-mm × 30-cm column that contains packing L1. The flow rate is about 2 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the column efficiency determined from the analyte peak is not less than 1000 theoretical plates; the tailing factor for the analyte peak is not more than 1.5; and the relative standard deviation for replicate injections is not more than 2.0%.
Procedure— Separately inject equal volumes (about 20 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 C10H15N·HCl in the portion of Methamphetamine Hydrochloride taken by the formula:
100C(rU / rS)
in which C is the concentration, in mg per mL, of USP Methamphetamine Hydrochloride 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 Clydewyn M. Anthony, Ph.D.
Senior Scientific Liaison
1-301-816-8139
(SM22010) Monographs - Small Molecules 2
Reference Standards RS Technical Services
1-301-816-8129
rstech@usp.org
USP35–NF30 Page 3842