Chemical stability of total parenteral nutrition mixtures

Manning, Ray; Washington, C.

doi:10.1016/0378-5173(92)90038-4

Cited by 15 publications

(5 citation statements)

References 104 publications

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“…As one of the main active ingredients, methionine (Met) is oxidized to methionine sulfoxide (MSO) in the presence of oxygen ( Figure 1) [19][20][21][22]. According to reports in the literature, MSO displays even higher toxicity in male hepatocytes than female hepatocytes [23,24].…”

Section: F I G U R E 1 the Degradation Impurities: Mso And Pgamentioning

confidence: 99%

Direct and simultaneous determination of methionine sulfoxide and pyroglutamic acid impurities in Compound Amino Acid Injection‐18 AA by ion‐pair reversed‐phase HPLC

Qin

et al. 2018

Separation Science Plus

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A direct and simultaneous determination of methionine sulfoxide and pyroglutamic acid impurities in Compound Amino Acid Injection‐18 AA by ion‐pair reversed‐phase high‐performance liquid chromatography with ultraviolet detection is described. The separation of both impurities in Compound Amino Acid Injection‐18 AA was accomplished with gradient elution consisting of acetonitrile and 10 mM diammonium hydrogen phosphate buffer (containing 15 mM sodium 1‐heptanesulfonate and obtaining pH 2.3 by addition of phosphoric acid). The limits of detection (μg/mL, S/N = 3:1) and quantification (μg/mL, S/N = 10:1) of methionine sulfoxide and pyroglutamic acid were 0.02 and 0.08, and 0.06 and 0.19, respectively. The linearity was in the range of 0.08–200.20 μg/mL for methionine sulfoxide and 0.19–201.20 μg/mL for pyroglutamic acid. The relatively simple method proved accurate (recovery 99.68–102.98% for methionine sulfoxide, 98.10–102.00% for pyroglutamic acid, n = 9) and precise (repeatability RSD = 1.06% for methionine sulfoxide, RSD = 0.60% for pyroglutamic acid, n = 6) in its application to commercial Compound Amino Acid Injection‐18 AA.

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Section: F I G U R E 1 the Degradation Impurities: Mso And Pgamentioning

confidence: 99%

Direct and simultaneous determination of methionine sulfoxide and pyroglutamic acid impurities in Compound Amino Acid Injection‐18 AA by ion‐pair reversed‐phase HPLC

Qin

et al. 2018

Separation Science Plus

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“…109,110 Given this complexity, caution is required before introducing substances (including medication) not known to be compatible and stable with PN and without knowing the consequence to the integrity of the PN preparation. The inclusion of nonnutrient medication with PN admixtures has not generally been.…”

Section: Questionmentioning

confidence: 99%

A.S.P.E.N. Clinical Guidelines

Boullata

Gilbert

Sacks

et al. 2014

J Parenter Enteral Nutr

265

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Background: Parenteral nutrition (PN) is a high-alert medication available for patient care within a complex clinical process. Beyond application of best practice recommendations to guide safe use and optimize clinical outcome, several issues are better addressed through evidence-based policies, procedures, and practices. This document provides evidence-based guidance for clinical practices involving PN prescribing, order review, and preparation. Method: A systematic review of the best available evidence was used by an expert work group to answer a series of questions about PN prescribing, order review, compounding, labeling, and dispensing. Concepts from the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) format were applied as appropriate. The specific clinical guideline recommendations were developed using consensus prior to review and approval by the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Board of Directors. The following questions were addressed: (1) Does education of prescribers improve PN ordering? (2) What is the maximum safe osmolarity of PN admixtures intended for peripheral vein administration? (3) What are the appropriate calcium intake and calciumphosphate ratios in PN for optimal neonatal bone mineralization? (4) What are the clinical advantages or disadvantages of commercially available premade ("premixed") multichambered PN formulations compared with traditional/customized PN formulations? (5) What are the clinical (infection, catheter occlusion) advantages or disadvantages of 2-in-1 compared with 3-in-1 PN admixtures? (6) What macronutrient dosing limits are expected to provide for the most stable 3-in-1 admixtures? (7) What are the most appropriate recommendations for optimizing calcium (gluconate) and (Na-or K-) phosphate compatibility in PN admixtures? (8) What micronutrient contamination is present in parenteral stock solutions currently used to compound PN admixtures? (9) Is it safe to use the PN admixture as a vehicle for non-nutrient medication delivery? (10) Should heparin be included in the PN admixture to reduce the risk of central vein thrombosis? (11) What methods of repackaging intravenous fat emulsion (IVFE) into smaller patient-specific volumes are safe? (12) What beyond-use date should be used for (a) IVFE dispensed for separate infusion in the original container and (b) repackaged IVFE? (JPEN J Parenter Enteral Nutr. 2014;38:334-377)

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“…Theoretically, there is an increased prevention of lipid peroxidation of the PUFA moiety when intravenous lipids are supplemented with liposoluble vitamin E. 9 AIO admixtures for adults are today well established by many investigations. [10][11][12][13] Acceptable standard ranges for nutrient contents have been developed to alert pharmacists to potential problems with formulation compatibility, stability, and deviation from normal clinical requirements. In contrast to PN for adults, there is little information about the stability of lipid-containing PN for children and even less for infants.…”

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confidence: 99%