Pentanoic acid, 5-amino-4-oxo-, hexyl ester, hydrochloride;
Hexyl 5-amino-4-oxopentanoate hydrochloride [140898-91-5]
BRIEFING
Hexaminolevulinate Hydrochloride. Because there is no existing USP monograph for this drug substance, a new monograph based on validated methods of analysis is proposed.
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The liquid chromatographic procedure for the Assay was validated using the XTerra RP18 brand of column with L1 packing. The typical retention time for hexaminolevulinate is about 6 min.
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The liquid chromatographic procedure for the test for the Limit of Aminolevulinic Acid was validated using the Symmetry C8 brand of column with L7 packing. The typical retention time for aminolevulinic acid is about 7 min.
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The liquid chromatographic procedure for the test for the Organic Impurities was validated using the XTerra RP18 brand of column with L1 packing. The typical retention time for hexaminolevulinate related compound C is about 8 min.
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The gas chromatographic procedure for the test for Limit of 1-Hexanol was validated using the Innowax brand of column with G16 phase. The typical retention time for 1-hexanol is about 20 min.
Description and solubility information: White to slightly yellow powder. Freely soluble in water and in ethanol; insoluble in heptane.
(SM3: A. Leeks, Jr.)
Case ID—SUB-1783