Abstract：
:The reaction between the high-dose drug substance 5-aminosalicylic acid (5-ASA) and the excipient citric acid during storage of an experimental enema preparation has been studied and three isobaric reaction products, i.e., an ester and an amide with non-symmetrically substituted citric acid moieties and a symmetrical amide, were identified by combined use of HPLC-SPE-NMR and HPLC-MS. After storage for 1 week at 70 degrees C, approximately 5% of the 5-ASA present in the formulation was transformed into these impurities. Storage of the enema for 32 months at room temperature led to loss of approximately 10% of the original amount of 5-ASA, with the ester as the main reaction product.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Larsen J,Staerk D,Cornett C,Hansen SH,Jaroszewski JWdoi
10.1016/j.jpba.2008.12.028subject
Has Abstractpub_date
2009-04-05 00:00:00pages
839-42issue
3eissn
0731-7085issn
1873-264Xpii
S0731-7085(08)00693-6journal_volume
49pub_type
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