L-Glutamic Acid, Hydrochloride
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
L-2-Aminoglutaric acid, hydrochloride;
2-Aminopentanedioic acid, hydrochloride CAS RN®: 138-15-8.
1 DEFINITION
L-Glutamic Acid, Hydrochloride, contains NLT 98.5% and NMT 101.5% of C5H9NO4·HCI, calculated on the dried basis.
2 IDENTIFICATION
Change to read:
SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197KA (CN 1-MAY-2020).
3 ASSAY
PROCEDURE
Sample: 100 mg of L-Glutamic Acid, Hydrochloride , previously dried
Analysis: Dissolve the Sample in 0.5 mL of water, add 15.0 mL of 0.1 N perchloric acid VS, and heat on a water bath for 30 min. After cooling, add 45 mL of glacial acetic acid, and titrate the excess perchloric acid with 0.1 N sodium acetate, determining the endpoint potentiometrically. Perform a blank determination (see Titrimetry (541)). Each mL of 0.1 N perchloric acid is equivalent to 18.36 mg of C5H9NO4·HCI.
Acceptance criteria: 98.5%-101.5% on the dried basis
4 IMPURITIES
Inorganic Impurities
RESIDUE ON IGNITION (281): NMT 0.25%
5 SPECIFIC TESTS
5.1 OPTICAL ROTATION, Specific Rotation (781S)
+25.2° to +25.8°, determined at 20°
Sample solution: 100 mg/mL, in 2 N hydrochloric acid
5.2 LOSS ON DRYING (731)
Dry a sample at 80° for 4 h: it loses NMT 0.5% of its weight.
6 ADDITIONAL REQUIREMENTS
6.1 PACKAGING AND STORAGE
Store in well-closed, light-resistant containers.
6.2 USP REFERENCE STANDARDS (11)
USP I-Glutamic Acid. Hydrochloride RS
