1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butynyl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-;
8-[(3R)-3-Aminopiperidin-1-yl]-7-(but-2-yn-1-yl)-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]-3,7-dihydro-1H-purine-2,6-dione [668270-12-0]
BRIEFING
Linagliptin. 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 used in the Assay was validated using the Inertsil ODS-2 brand of column with L1 packing. The typical retention time for linagliptin is about 5 min.
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The liquid chromatographic procedure used in the test for Organic Impurities, Procedure 1 was validated using the Hypersil Gold aQ brand of column with L1 packing. The typical retention time for linagliptin is about 9 min.
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The liquid chromatographic procedure used in the test for Organic Impurities, Procedure 2 was validated using the Kromasil C-18 brand of column with L1 packing. The typical retention time for linagliptin is about 15 min.
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The liquid chromatographic procedure used in the test for Enantiomeric Purity was validated using the Chiralpak IA-3 brand of column with L99 packing. The typical retention time for linagliptin is about 19 min.
Description and solubility information: White to yellowish powder. Soluble in methanol; sparingly soluble in ethanol; very slightly soluble in water, isopropanol, and acetone.
(SM3: R. Fales)
Case ID—SUB-82, SUB-407, SUB-1647