Stability and Compatibility of Etoposide in Normal Saline
Bibliographic record
Abstract
ABSTRACT Objective: At concentrations greater than 0.4 mg/mL, solutions of etoposide in normal saline are unstable, and the drug precipitates quickly. However, the stability of this drug at much higher concentrations has not been examined. This study was undertaken to evaluate the stability and compatibility of solutions of etoposide in 0.9% sodium chloride (normal saline [NS]), ranging in concentration from 0.20 to 12.00 mg/mL and stored in glass test tubes for 22 days at room temperature (24°C) and in the refrigerator (4°C). Method: Solutions of etoposide in NS (0.20 to 12.00 mg/mL) were prepared and stored at room temperature (24°C) and in the refrigerator (4°C). A validated, stability-indicating highpressure liquid chromatographic method was used to determine the concentration of the drug on days 0, 1, 2, 5, 7, 14, and 22. Samples were inspected visually to check for the formation of a precipitate. Results: Etoposide solutions from 0.20 to 0.50 mg/mL and those of 9.50 mg/mL or more were stable for at least 24 h at both temperatures, retaining more than 90% of their initial concentration. The 8.00 mg/mL solution stored at 4°C was also stable for this period. Solutions of 2.00, 4.00, and 6.00 mg/mL precipitated within 2 h. Solutions of 1.00 to 8.00 mg/mL lost more than 10% of their initial concentration within 24 h. Solutions of 0.20, 11.00, and 12.00 mg/mL retained more than 90% of the initial concentration over the full 22-day study period, and no precipitate was observed. Conclusions: The compatibility of etoposide in 0.9% NS is concentration-dependent. Etoposide solutions at lower concentrations (up to 0.50 mg/mL) retained most of their initial concentration for at least 24 h, and stronger solutions (10.00 mg/mL or more) retained most of their initial concentration for at least 7 days. It is recommended that storage of etoposide solutions in NS (concentration 10 mg/mL or more) at 4°C or 24°C not exceed 5 days, depending on solution sterility and bacterial contamination rate in the particular IV admixture program. Under these conditions, more than 94% of the initial concentration of the drug should be retained. RESUME Objectif : Les solutions d’etoposide, a des concentrations superieures a 0,4 mg/mL de solution physiologique salee, sont instables et forment rapidement un precipite. Toutefois, la stabilite de cet agent a des concentrations superieures n’a pas ete evaluee. Cette etude a ete menee afin d’evaluer la stabilite et la compatibilite de l’etoposide preparee dans solutions de chlorure de sodium a 0,9 % (solution physiologique salee; NS), a des concentrations allant de 0,20 a 12,00 mg/mL, puis entreposees dans des eprouvettes en verre durant 22 jours, a la temperature ambiante de 24 °C et au refrigerateur a 4 °C. Methode : Les solutions d’etoposide dans du NS (0,20 a 12,00 mg/mL) ont ete preparees puis entreposees a la temperature ambiante (24 °C) et au refrigerateur (4°C). La concentration des solutions en medicament a ete determinee au moyen d’une epreuve de stabilite par chromatographie liquide a haute pression validee, aux jours 0, 1, 2, 5, 7, 14, et 22. Les echantillons ont ete inspectes visuellement a la recherche d’un precipite. Resultats : Les solutions d’etoposide aux concentrations allant de 0,20 a 0,50 mg/mL et celles de 9,50 mg/mL ou plus sont restees stables durant au moins 24 heures aux deux temperatures et ont conserve plus de 90 % de leur concentration initiale en medicament. Les solutions de 8,00 mg/mL conservees a 4 °C sont egalement restees stables durant cette periode. Les solutions de 2,00, 4,00, et 6,00 mg/mL ont forme un precipite apres deux heures. Les solutions de 1,00 a 8,00 mg/mL ont perdu plus de 10 % de leur concentration initiale en 24 heures. Les solutions de 0,20, 11,00 et 12,00 mg/mL ont conserve plus de 90 % de leur concentration initiale pendant les 22 jours qu’a dure l’etude et n’ont forme aucun precipite. Conclusion : La compatibilite de l’etoposide preparee dans un NS a 0,9 % est fonction de la concentration. Les solutions d’etoposide de plus faible concentration (jusqu’a 0,50 mg/mL) ont conserve la plus grande partie de leur concentration initiale en medicament pendant au moins 24 heures, et les solutions a plus forte concentration (10,00 mg/mL ou plus) ont conserve leur concentration initiale en medicament pendant au moins sept jours. Il est recommande de ne pas conserver les solutions d’etoposide dans du NS (a des concentrations de 10 mg/mL ou plus) a 4 °C ou a 24 °C pendant plus de cinq jours, en tenant compte de la sterilite de la solution et du taux de contamination bacterienne relatif au programme d’additifs aux solutes intraveineux de chaque etablissement. Dans ces conditions, les solutions devraient retenir plus de 94 % des concentrations initiales en medicament.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".