Stability of Oxycodone Hydrochloride for Injection in Dextrose and Saline Solutions
Bibliographic record
Abstract
ABSTRACT Objective: To evaluate the stability, over 35 days of storage at either 4°C or 24°C, of oxycodone hydrochloride 100 mg/mL in sterile water, stored in plastic syringes, and oxycodone hydrochloride 5 and 50 mg/mL in 0.9% sodium chloride (NS) or 5% dextrose in water (D5W), stored in polyvinylchloride (PVC) minibags. Methods: Oxycodone concentrations were determined on each of the study days (days 0, 1, 3, 7, 10, 14, 17, 21, 28, and 35) by means of a validated, stability-indicating, liquid chromatographic method with ultraviolet detection at 230 nm. Physical inspections and pH determinations were also completed on each study day. Results: Validation demonstrated that oxycodone could be quantified accurately and reproducibly. Maximum deviation from the nominal concentration of standards and quality control samples was less than 5%. Intra- and inter-day analytical reproducibility error, as measured by coefficient of variation, averaged less than 3%. During the study period, the concentrations observed in all study samples retained at least 95.6% of their initial concentrations. All solutions remained clear and colourless, with no visible precipitate, for the duration of the study. The pH of all solutions varied by less than 0.1 pH unit. Conclusions: Oxycodone hydrochloride 100 mg/mL in sterile water retained more than 95% of the initial concentration during 35 days of storage in plastic syringes at 4°C and 24°C. Furthermore, 5 and 50 mg/mL solutions prepared by diluting the 100 mg/mL solution in NS or D5W retained more than 95% of their initial drug concentration during 35 days of storage in PVC minibags at 4°C and 24°C. RESUME Objectif : Evaluer la stabilite des solutions de chlorhydrate d’oxycodone entreposees pendant 35 jours a 4 °C ou 24 °C, melangees d’une part dans de l’eau sterile, a des concentrations de 100 mg/mL, et conservees dans des seringues de plastique, et d’autre part, dans du chlorure de sodium a 0,9 % (NS) ou de dextrose a 5 % dans l’eau (D5W), a des concentrations de 5 et de 50 mg/mL, et conservees dans des minisacs de chlorure de polyvinyle (PVC). Methodes : Les concentrations d’oxycodone ont ete mesurees a chaque jour de l’etude (jours 0, 1, 3, 7, 10, 14, 17, 21, 28 et 35) au moyen d’une epreuve valide de stabilite par chromatographie liquide a haute pression et par detecteur ultraviolet a 230 nm. L’inspection visuelle et la mesure du pH ont aussi ete realisees a chaque jour de l’etude. Resultats : Les tests de validation ont demontre que les resultats pouvaient etre mesures quantitativement de facon precise et reproductible. L’ecart maximal a partir des concentrations nominales des echantillons standards et de controle de la qualite etait moins de 5 %. L’erreur de la reproductibilite analytique pour une meme journee et d’une journee a l’autre, telle que mesuree par le coefficient de variation, etait en moyenne de moins de 3 %. Tous les echantillons a l’etude pendant toute la periode de l’etude ont conserve au moins 95,6 % leurs concentrations initiales. Toutes les solutions etaient claires et incolores, sans aucun precipite visible, pendant toute la duree de l’etude. Le pH de toutes les solutions a varie par moins de 0,1. Conclusions : Les solutions de chlorhydrate d’oxycodone preparees a raison de 100 mg/mL d’eau sterile ont retenu plus de 95 % de leurs concentrations initiales durant les 35 jours qu’elles ont ete conservees dans des seringues de plastique, a 4 °C et a 24 °C. De plus, les solutions a 5 et a 50 mg/mL, preparees en diluant la solution de 100 mg/mL dans du NS ou du D5W, ont retenu plus de 95 % de leurs concentrations initiales pendant les 35 jours qu’elles ont ete conservees dans des minisacs de PVC, a 4 °C et a 24 °C.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| 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) | 0.000 | 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 teacher head, 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".