Development of a new sodium diclofenac certified reference material using the mass balance approach and 1H qNMR to determine the certified property value

Quantitative NMR Studies of Multiple Compound Mixtures

“…qNMR has been increasingly employed for purity evaluation of reference standards [185], which is usually much easier and faster than traditional mass balance approach including quantification of all impurities (as well as moisture and ash). For example, Nogueira et al [161] adopted mass balance approach and 1 H qNMR to determine the certified property value of sodium diclofenac certified reference material (CRM), and achieved satisfactory results. Similarly, qNMR was established for purity determination of pharmaceutical reference materials by Shen et al [165], who investigated the accuracy and precision of the qNMR method for purity determination of six types of angiotensin-converting enzyme (ACE) inhibitors reference standards.…”

Об Аттестации Стандартных Образцов В Фармации: Метод Баланса Масс

“…Ñëåäóåò îòìåòèòü, ÷òî èìåþòñÿ ïóáëèêàöèè, â êîòîðûõ äëÿ îïðåäåëåíèÿ ñîäåðaeàíèÿ îñíîâíîãî âåùåñòâà è ïðèìåñåé (X RelSub ) â àòòåñòóåìûõ ñóáñòàíöèÿõ ïðèìåíÿþò ßÌÐ [18,22,27] èëè ÄÑÊ [19,21,23,25]. Ïðè ýòîì ìåòîä ÄÑÊ èñïîëüçóþò êàê ïðÿìîé ìåòîä îïðåäåëåíèÿ X RelSub , à ìåòîä ßÌÐ -êàê êîñâåííûé: èç 100 % âû÷èòàþò ñîäåðaeàíèå îñíîâíîãî âåùåñòâà, ðàññ÷èòàííîå ïî äàííûì ßÌÐ.…”

Universal quantitative NMR analysis of complex natural samples

“…Moreover, qHNMR has been demonstrated to be a competitive metrological technique for the purity certification of organic compounds, with a reliable estimation of chemical purity defined by an accuracy and precision of ±1%, and an uncertainty of measurement less than 0.1% [12 • , 13 • , 14]. In fact, qHNMR is powerful enough to be used as a reference method for the validation of other analytical chromatographic techniques [12 • , 14].…”

“…In fact, qHNMR is powerful enough to be used as a reference method for the validation of other analytical chromatographic techniques [12 • , 14]. The recognition of qHNMR as a reference method is exemplified by its application for qualitative and quantitative analysis of several compounds such as non-fractionated heparin sodium [15] in pharmacopeial methods [6, 12 • ].…”