2-Piperidineacetic acid, α-phenyl-, methyl ester, hydrochloride, (αR,2R)-;
Methyl (R)-2-phenyl-2-[(R)-piperidin-2-yl]acetate hydrochloride. [19262-68-1]
BRIEFING
Dexmethylphenidate Hydrochloride. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is being proposed.
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The liquid chromatographic procedure in the Assay and in the test for Organic Impurities was validated using the Luna C18 brand of column with L1 packing. The typical retention time for dexmethylphenidate is about 19 min.
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The liquid chromatographic procedure in the test for the Limit of S, S-Methylphenidate Hydrochloride was validated using the Astec Chirobiotic V2 brand of column with L88 packing. The typical retention time for dexmethylphenidate is about 8 min.
Description and Solubility information: White, to off-white powder. Freely soluble in water and methanol; soluble in alcohol; slightly soluble in chloroform and acetone.
(SM 4: Y. Yang)
Case ID—SUB-1285; SUB-1301
USP REFERENCE STANDARDS FOR PURCHASE
USP Methylphenidate Hydrochloride Erythro Isomer Solution RSUSP Methylphenidate Hydrochloride RS
USP Methylphenidate Related Compound A RS