Stability of extemporaneously prepared acetylcysteine 1% and 10% solutions for treatment of meconium ileus

Fohl, Alexander L.; Johnson, Cary E.; Cober, M. Petrea

doi:10.2146/ajhp100214

Cited by 10 publications

(7 citation statements)

References 14 publications

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“…Literature reports the formation of impurities B, C and D on subjecting the aqueous solution, and cough syrup to various forced degradation conditions. 39,40 From the forced degradation study conducted in our lab it is clear that known impurities B, C and D are degradation impurities which need to be strictly monitored during stability studies.…”

Section: Discussionmentioning

confidence: 99%

“…[30][31][32][33] The related substances [ Figure 34,35 Among chromatographic methods literature reveals separation methods like reverse phase HPLC and ion pair chromatography for related substances test of NAC in bulk and drug products. [34][35][36][37][38][39][40][41][42][43][44] Literature also reports expensive and less widely available techniques like LC-UV-MS 44 and capillary electrophoresis-mass spectrometry 25 for quantifying the related substances of acetyl cysteine. According to our findings, none of the currently available analytical methods is stability indicating.…”

Section: Introductionmentioning

confidence: 99%

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Development and Validation of an Analytical Method for Related Substances in N-acetyl–L-cysteine Effervescent Tablets by RP-HPLC

Mathew¹,

Ravi²,

Rameshwar³

et al. 2017

IJPER

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Background:The reported chromatographic methods for N-acetyl cysteine [NAC] are reverse phase HPLC and ion pair chromatography [IPC] for related substances test in bulk and in formulations. No reported stability indicating methods for the estimation of related substances in NAC effervescent formulation was found in literature. Objective: The present work was aimed at developing a selective, sensitive and reproducible stability indicating high-performance liquid chromatographic method for the quantitative determination of known, unknown impurities, degradation impurities and processrelated impurities of NAC effervescent formulation. Method: A reversed phase ion pair chromatographic method was developed employing Cadenza C18 column as the stationary phase and 0.01M octane sulphonate [pH 2.20], methanol and acetonitrile in the ratio 90:8:2 as the mobile phase. A gradient programme was followed with a run time of 55 minutes. 0.3 M hydrochloric acid was selected as the optimum diluent. The performance of the method was validated according to the ICHQ2R1 guidelines. Results: The method was found to be linear from 1.5 to 25µg/ml for impurities A, C and D and from 2.0 to 25 µg/ml for impurity B. The official impurities C and D were mapped in all stress conditions. Additionally, impurity B was also seen in acidic conditions. Conclusion: The results from the study demonstrate that the method is suitable for evaluating the stability of NAC effervescent tablet. Key words: N-acetyl cysteine, Reverse phase HPLC, Effervescent formulation, Ion pair chromatography, Related substances,Validation. Key message: An ion pair chromatographic method was developed for quantifying the related substances of N-acetyl cysteine effervescent Tablets. Selection of diluent was an important variable in the method development.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Development and Validation of an Analytical Method for Related Substances in N-acetyl–L-cysteine Effervescent Tablets by RP-HPLC

Mathew¹,

Ravi²,

Rameshwar³

et al. 2017

IJPER

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“…8 Stability of preparations has become a major focus in the formulation, production, and storage of insulin since its introduction in the 1920s. 9 Investigators have studied various additives, such as cyclodextrins, amino acids, and zinc, to stabilize the bonds and varied external factors such as temperature and pH to assess the effects of the environment. 12,14…”

Section: Discussionmentioning

confidence: 99%

“…Time points were considered stable if the mean concentration of the samples exceeded 90% of the equilibrium concentration at hour 6. 8-11…”

Section: Methodsmentioning

confidence: 99%

Stability of Regular Human Insulin Extemporaneously Prepared in 0.9% Sodium Chloride in a Polyvinyl Chloride Bag

et al. 2012

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Purpose The purpose of this study was to evaluate the extended stability of extemporaneously prepared regular human insulin 100 units in 0.9% sodium chloride at a total volume of 100 mL under refrigeration. Methods Three admixtures of regular human insulin were prepared aseptically under a laminar flow hood at time zero. They were prepared by withdrawing 1 mL of regular human insulin with a concentration of 100 units/mL and adding it to a sufficient quantity of 0.9% sodium chloride for injection in a Polyvinylchloride (PVC) bag to yield a total volume of 100 mL. The 3 admixtures were stored refrigerated(2°C to 8°C [36°F to 46°F]) and three 1 mL samples of each admixture were withdrawn, transferred to a test tube, and frozen(–30°C to −15°C [–22°F to 5°F]) at hours 0, 6, 12, 36, 48, 72, 96, 120, 144, and 168. Insulin concentrations were measured by chemiluminescent immunoassay. The time points were considered stable if the mean concentration of the samples exceeded 90% of the equilibrium concentration at hour 6. Results The equilibrium concentration was 0.57 units/mL. Time points were considered stable if the mean concentration was at least 0.52 units/mL. All time points retained at least 90% of the equilibrium concentration with the exception of hour 120(0.46 ± 0.05 units/mL). At hour 168, the mean concentration was 0.63 ± 0.07 units/mL. Conclusion Regular human insulin 100 units added to 0.9% sodium chloride for injection in a PVC bag to yield a total volume of 100 mL is stable for 168 hours when stored at 2°C to 8°C(36°F to 46°F).

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“…This study aims to evaluate the stability in aerosol containers of two mucolytic agents, N-acetylcysteine (300 mg/3 ml) and ambroxol (15 mg /2ml), and two corticosteroids beclomethasone dipropionate (800 μg /2ml) and budesonide (0.50 mg /2ml and 0.25 mg /2ml), after dilution with Sirmione thermal water stored in plastic ampoules, for aerosol therapy. A large number of analytical methods for the determination and quantifi cation of N-acetylcysteine [11,12], ambroxol [13,14], budesonide [15] and beclomethasone dipropionate [16,17] in pharmaceutical preparations have been developed. However, in spite of the structural diversity and different chemical-physical properties of these drugs (Figure 1), mainly due to the presence of excipients (sodium edetate, polysorbate 80, polysorbate 20, and sorbitan laurate) that can interfere with the separation process, no method was found for their simultaneous analysis.…”

Section: Introductionmentioning

confidence: 99%

Chemical and physical stability of selected drugs for aerosol therapy with Sirmione thermal water

Cuna¹,

Sturani²,

Galfrè³

et al. 2021

Open Journal of Chemistry

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Stability of extemporaneously prepared acetylcysteine 1% and 10% solutions for treatment of meconium ileus

Abstract: Extemporaneously prepared solutions of acetylcysteine 1% (10 mg/mL) and 10% (100 mg/mL) prepared with bacteriostatic 0.9% sodium chloride for injection were stable for at least 60 days when stored in plastic amber bottles at room temperature.

Cited by 10 publications

References 14 publications

Development and Validation of an Analytical Method for Related Substances in N-acetyl–L-cysteine Effervescent Tablets by RP-HPLC

Development and Validation of an Analytical Method for Related Substances in N-acetyl–L-cysteine Effervescent Tablets by RP-HPLC

Stability of Regular Human Insulin Extemporaneously Prepared in 0.9% Sodium Chloride in a Polyvinyl Chloride Bag

Chemical and physical stability of selected drugs for aerosol therapy with Sirmione thermal water

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