Three approaches to the analysis of trace formaldehyde in bulk and dosage from pharmaceuticals.
Trace-level determinations for the presence of formaldehyde in both bulk and dosage form pharmaceuticals were developed using three innovative strategies. One system adapted the chromotropic acid spot test for formaldehyde. This was accomplished spectrophotometrically over a linear detection range against authentic control samples. The other two chromatographic approaches necessitated rapid derivatization. One derivative was its corresponding oxime, formaldoxime, which was resolved on a gas chromatographic porous polymer column and sensed by a nitrogen-specific detector. The other derivative, sodium formate, was detected and quantified on an ion chromatograph using an anion-exchange column and a conductivity detector. The chromotropic acid technique was sensitive but not specific for formaldehyde. The chromatographic techniques required a high degree of water solubility. All were subject to interferences that could preclude their use for a particular application. None of the tested samples, which included a penicillin analogue, a pharmaceutical dosage from additive, a vitamin, and biological proteins, showed the presence of formaldehyde at trace levels.
Manius
G J
GJ
Roche Pharmaceuticals, Nutley, New Jersey 07110-1199.
Wen
L F
LF
Palling
D
D
D002849:Chromatography, Gas; D002852:Chromatography, Ion Exchange; D004304:Dosage Forms; D005557:Formaldehyde / Q000032:analysis*; D005634:Fructose-Bisphosphate Aldolase / Q000737:chemistry; D006898:Hydroxylamines / Q000032:analysis; D007202:Indicators and Reagents; D010091:Oximes / Q000032:analysis; D010406:Penicillins / Q000032:analysis; D011506:Proteins / Q000032:analysis; D013056:Spectrophotometry, Ultraviolet
D004304:Dosage Forms; D006898:Hydroxylamines; D007202:Indicators and Reagents; D010091:Oximes; D010406:Penicillins; D011506:Proteins; D005557:Formaldehyde; D005634:Fructose-Bisphosphate Aldolase