Separation and characterization of impurity P in azithromycin product

Guo, Nian; He, Quan; Jin, Yong; Hou, Zhouke; Pan, Yuanjiang; Liu, Jian; Sun, Cuirong

doi:10.1016/j.jpba.2020.113853

Cited by 3 publications

(2 citation statements)

References 14 publications

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“…The analyses show all mixture components and are nearly free of any background ions; the m / z 591 is tentatively assigned as fragment ion of azithromycin. 89 For some drugs and thermometer molecules, there has been some tendency of low-intensity fragmentation by vMAI, despite that no energy is added (laser, heat, voltages) to promote analyte ionization. 90,91 The analyses of urine are also straightforward.…”

Section: Resultsmentioning

confidence: 99%

Instrumentation development, improvement, simplification, and miniaturization: The multifunctional plate source for use in mass spectrometry

Trimpin,

Inutan,

Coffinberger

et al. 2023

Eur J Mass Spectrom (Chichester)

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In remembrance of Prof. Dr Przybylski, we are presenting a vision towards his beloved mass spectrometry (MS) and its far-reaching promises outside of the academic laboratory. Sub-atmospheric pressure (AP) ionization MS is well positioned to make a step-change in direct ionization, a concept that allows sublimation/evaporation ionization and mass analyses of volatile and nonvolatile molecules from clean or dirty samples, directly, accurately, sensitively, and in a straightforward manner that has the potential to expand the field of MS into unchartered application areas. Contrary to ambient ionization MS, ionization commences in the sub-AP region of the mass spectrometer, important for practical and safety reasons, and offers inter alia, simplicity, speed, sensitivity, and robustness directly from real-world samples without cleanup. The plate source concept, presented here, provides an easy to use, rapid, and direct sample introduction from AP into the sub-AP of a mass spectrometer. Utilizing sub-AP ionization MS based on the plate source concept, small to large molecules from various environments that would be deemed too dirty for some direct MS methods are demonstrated. The new source concept can be expanded to include multiple ionization methods using the same plate source “front end” without the need to vent the mass spectrometer between the different methods, thus allowing ionization of more compounds on the same mass spectrometer for which any one ionization method may be insufficient. Examples such as fentanyl, gamma-hydroxybutyric acid, clozapine, 1-propionyllysergic acid, hydrocodone angiotensin I and II, myoglobin, and carbonic anhydrase are included.

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Section: Resultsmentioning

confidence: 99%

Instrumentation development, improvement, simplification, and miniaturization: The multifunctional plate source for use in mass spectrometry

Trimpin,

Inutan,

Coffinberger

et al. 2023

Eur J Mass Spectrom (Chichester)

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show abstract

“…An important factor for the safety and effectiveness of pharmaceuticals is the purity of the drug, making impurity profiling critical [7,8]. Various unknown impurities could form in the drug product during formulation, manufacturing, and storage as well as in the synthesis of the active pharmaceutical ingredient (API) [9].…”

Section: Introductionmentioning

confidence: 99%

Detection and Identification of an Unknown Impurity in Ephedrine HCl 5 mg/mL Cyclic Olefin Syringes: Formulation Development

et al. 2023

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An unknown impurity was detected in in-house prepared ephedrine hydrochloride (HCl) 5 mg/mL prefilled sterilized syringes when applying a stability-indicating British Pharmacopoeia 2018 impurity method for ephedrine injection. Ultraviolet, chromatographic, mass spectral, and physicochemical methods were combined to identify the unknown impurity. The unknown impurity was identified as methcathinone, which is generated from ephedrine drug substance through an oxidation reaction. A formulation study, in which different process adjustments were tested, was carried out to reduce the amount of unknown impurity. Nitrogen gassing in combination with 0.05 M citrate buffer addition proved to be the most potent process adjustment in reducing methcathinone formation in ephedrine HCl 5 mg/mL prefilled sterilized syringes after 4 months of storage in the dark at room temperature (20 °C ± 5 °C). More detailed research on the long-term stability of the reformulated ephedrine HCl drug product is currently underway, with promising results for up to 9 months gathered already.

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Recent Progresses in Analytical Perspectives of Degradation Studies and Impurity Profiling in Pharmaceutical Developments: An Updated Review

Jahani

Bazzaz

Akaberi

et al. 2022

Critical Reviews in Analytical Chemistry

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Separation and characterization of impurity P in azithromycin product

Cited by 3 publications

References 14 publications

Instrumentation development, improvement, simplification, and miniaturization: The multifunctional plate source for use in mass spectrometry

Instrumentation development, improvement, simplification, and miniaturization: The multifunctional plate source for use in mass spectrometry

Detection and Identification of an Unknown Impurity in Ephedrine HCl 5 mg/mL Cyclic Olefin Syringes: Formulation Development

Recent Progresses in Analytical Perspectives of Degradation Studies and Impurity Profiling in Pharmaceutical Developments: An Updated Review

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