C5H11NO2·HCl 153.61

Methanaminium, 1-carboxy-N, N, N-trimethyl-, chloride.
Betaine hydrochloride.
(Carboxymethyl)trimethylammonium chloride [590-46-5].

Packaging and storage— Preserve in well-closed containers.

USP Reference standards 11 — USP Betaine Hydrochloride RS.

Identification—

pH 791 : between 0.8 and 1.2, in a solution (1 in 4).

Water, Method I 921 : not more than 0.5%.

Residue on ignition 281 : not more than 0.1%.

Heavy metals 231 : 0.001%.

Residual solvents 467: meets the requirements.

Assay— Transfer about 400 mg of Betaine Hydrochloride, accurately weighed, to a conical flask, add 50 mL of glacial acetic acid, and heat gently with swirling until solution is complete. Add 25 mL of mercuric acetate TS, cool, add 2 drops of crystal violet TS, and titrate with 0.1 N perchloric acid VS to a green endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 15.36 mg of C5H11NO2·HCl.

Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine

USP29–NF24 Page 264

Phone Number : 1-301-816-8251