2006
DOI: 10.1016/j.jpba.2005.12.033
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Simultaneous determination of formic acid and formaldehyde in pharmaceutical excipients using headspace GC/MS

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Cited by 98 publications
(52 citation statements)
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“…As can be seen in Figure 2, the relative amount of formaldehyde produced is heavily affected by the amount of CA present, consistent with the concept that PEG that is less mobile due to interactions with CA, shows less degradation. It should be noted that subsequent to this work, a method was reported in the literature 22 for simultaneous determination of formaldehyde and formic acid using headspace GC/MS.…”
Section: Resultsmentioning
confidence: 99%
“…As can be seen in Figure 2, the relative amount of formaldehyde produced is heavily affected by the amount of CA present, consistent with the concept that PEG that is less mobile due to interactions with CA, shows less degradation. It should be noted that subsequent to this work, a method was reported in the literature 22 for simultaneous determination of formaldehyde and formic acid using headspace GC/MS.…”
Section: Resultsmentioning
confidence: 99%
“…A similar mechanism, i.e., generation of an acid during storage, could be applicable to calcium acetate hydrate, which was shown to promote acid-catalyzed degradation of the API in the present study. In addition, acidic impurities were reported in hydroxypropyl methylcellulose (up to 100 ppm), povidone (up to 1000 ppm), and sodium starch glycolate (up to 140 ppm) (30,31). Therefore, both the low pH eq and the incompatibility of atorvastatin calcium with Polyplasdone XL (crospovidone), PROSOLV SMCC 90 (silicified microcrystalline cellulose), EXPLOTAB® (sodium starch glycolate), observed in this study, may be attributed, at least in part, to the presence of acidic impurities on the surface of these excipients.…”
Section: Discussionmentioning
confidence: 99%
“…1) is most likely formed in the tablets by the reaction with formic acid. Organic acids, such as formic acid, are common impurities in poly(ethylene glycol) (PEG), hydroxypropyl methylcellulose (HPMC), povidone, and polyvinyl alcohol (6,12). Often, excipients with formaldehyde impurities also contain some formic acid due to oxidation of formaldehyde to formic acid by atmospheric oxygen.…”
Section: Effect Of Different Odt Platforms On Benzocaine Stabilitymentioning
confidence: 99%