Stress Testing

Baertschi, Steven W.; Alsante, Karen M.

doi:10.1201/9780849359194.ch14

Cited by 28 publications

(48 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Accelerated stress conditions, including heat, humidity and light, have become a popular parameter for evaluating the reliability of drug products within short testing periods. 11,12 Our previous study provided the first evidence of thermally induced anhydride formation in Eudragit E, a copolymer composed of butyl methacrylate, 2-dimethylaminoethyl methacrylate and MMA in the composition 1:2:1. 13 PVA copolymer has also been copolymerized by AA and MAA with PVA, 5-7 but the thermal stability has not yet been investigated.…”

Section: Introductionmentioning

confidence: 99%

DSC-FTIR microspectroscopy used to investigate the heat-induced intramolecular cyclic anhydride formation between Eudragit E and PVA copolymer

Lin¹,

Cheng²,

Wei³

et al. 2011

Polym J

View full text Add to dashboard Cite

Section: Introductionmentioning

confidence: 99%

DSC-FTIR microspectroscopy used to investigate the heat-induced intramolecular cyclic anhydride formation between Eudragit E and PVA copolymer

Lin¹,

Cheng²,

Wei³

et al. 2011

Polym J

View full text Add to dashboard Cite

“…Another drug degradation mechanism is catalyzed by light, which also plays an important role in thermal oxidation [25] . However, the composite effect of light on drug stability is difficult to measure because of the dependence of degradation on the wavelength.…”

Section: Discussionmentioning

confidence: 99%

Stability study on an anti-cancer drug 4-(3,5-bis(2-chlorobenzylidene)-4-oxo-piperidine-1-yl)-4-oxo-2-butenoic acid (CLEFMA) using a stability-indicating HPLC method

Raghuvanshi

Nkepang

Hussain

et al. 2017

Journal of Pharmaceutical Analysis

View full text Add to dashboard Cite

CLEFMA, 4-(3,5-bis(2-chlorobenzylidene)-4-oxo-piperidine-1-yl)-4-oxo-2-butenoic acid, is a new chemical entity with anti-cancer and anti-inflammatory activities. Here, we report its stability in solution against stress conditions of exposure to acid/base, light, oxidant, high temperature, and plasma. The identity of the degradation products was ascertained by mass and proton nuclear magnetic resonance spectroscopy. To facilitate this study, we developed and validated a reverse phase high performance liquid chromatography method for detection of CLEFMA and its degradation. The method was linear over a range of 1–100 µg/mL; the accuracy and precision were within acceptable limits; it was stability-indicating as it successfully separated cis-/trans-isomers of CLEFMA as well as its degradation product. The major degradation product was produced from amide hydrolysis at maleic acid functionality caused by an acidic buffer, oxidant (3% hydrogen peroxide), or temperature stress (40–60 °C). The log k-pH profile showed that CLEFMA was most stable at neutral pH. In accelerated stability study we found that the shelf-life (T90%) of CLEFMA at 25 °C and 4 °C was 45 days and 220 days, respectively. Upon exposure to UV-light (365 nm), the normally prevalent trans-CLEFMA attained cis-configuration. This isomerization also involved the maleic acid moiety. CLEFMA was stable in plasma from which it could be efficiently extracted by an acetonitrile precipitation method. These results indicate that CLEFMA is sensitive to hydrolytic cleavage at its maleic acid moiety, and it is recommended that its samples should be stored under refrigerated and light-free conditions, and under inert environment.

show abstract

“…In the ester type of drugs in liquid dosage form undergoes hydrolysis. The most common examples include procaine, chloramphenicol, atropine, methyl phenindate, benzyl penicillin, oxazepam and lincomycin [76].…”

Section: Functional Group Related Degradationmentioning

confidence: 99%

Impurity Profiling of Drugs Towards Safety and Efficacy: Theory and Practice

Dhangar

Jagtap

Surana

et al. 2017

J. Chil. Chem. Soc.

View full text Add to dashboard Cite

Last decade has witnessed enormous changes in the studies of impurity profiling of drugs which can be reflected from pharmacopoeia and regulatory guidelines. The present review article is an attempt to provide comprehensive knowledge about various aspects and details about the impurity profiling in context with regulatory guidelines. Article also focused on isolation, separation and characterization techniques of impurities. It gives preliminary idea about applicability of virtual software used for studies on safety limit for impurities. The comprehensive information related to residual solvents, residual metals and genotoxicity studies of isolated impurities have also been incorporated into present article.

show abstract

Stress Testing

Cited by 28 publications

References 0 publications

DSC-FTIR microspectroscopy used to investigate the heat-induced intramolecular cyclic anhydride formation between Eudragit E and PVA copolymer

DSC-FTIR microspectroscopy used to investigate the heat-induced intramolecular cyclic anhydride formation between Eudragit E and PVA copolymer

Stability study on an anti-cancer drug 4-(3,5-bis(2-chlorobenzylidene)-4-oxo-piperidine-1-yl)-4-oxo-2-butenoic acid (CLEFMA) using a stability-indicating HPLC method

Impurity Profiling of Drugs Towards Safety and Efficacy: Theory and Practice

Contact Info

Product

Resources

About