Physical Compatibility and Chemical Stability of Bupivacaine and Hydromorphone in Polypropylene Syringes
Bibliographic record
Abstract
ABSTRACT Background: Narcotics are combined with local anesthetic agents for epidural administration during many surgical procedures. A literature review revealed one chemical stability study for bupivacaine combined with hydromorphone and packaged in polyvinyl chloride bags and one physical stability study for this drug combination packaged in polypropylene syringes. Objective: A physical compatibility and chemical stability study was undertaken to determine a shelf life that would allow batch preparation of this drug combination, for storage in polypropylene syringes, without significant wastage. Methods: Bupivacaine (0.5%) was diluted with normal saline (0.9% sodium chloride) to prepare a 0.25% solution, which was then combined with hydromorphone such that the final concentration of the latter was either 0.02 or 0.04 mg/mL. These mixtures were then packaged in polypropylene syringes and stored either at 22°C with exposure to fluorescent light or at 6°C with protection from light. Five-millilitre samples were taken from each syringe on days 0, 7, 14, 28, 56, and 91 and frozen at –70°C. All samples were monitored for colour, clarity, and changes in pH, in addition to undergoing duplicate analysis with a stability-indicating high-pressure liquid chromatography assay. Results: All samples remained colourless and free of precipitate throughout the study. There were no significant changes in pH under either of the storage conditions. Both the bupivacaine (0.25%) and the hydromorphone (0.02 or 0.04 mg/mL) stored in combination at either 22°C with exposure to light or 6°C with protection from light remained stable for 91 days. Conclusions: Bupivacaine (0.25%) with hydromorphone (0.02 or 0.04 mg/mL) packaged in polypropylene syringes and stored either at 22°C with exposure to light or at 6°C with protection from light were considered stable for at least 91 days. At the author’s institution, a 30-day expiry date has been established on the basis of the institutional sterile packaging policy. Facilities wishing to use the physical compatibility and chemical stability information provided here should first perform their own institution- specific sterile packaging testing. RESUME Historique : On administre des narcotiques en association avec des anesthesiques locaux par voie epidurale dans le cadre de nombreuses interventions chirurgicales. Une revue de la litterature a fait etat d’une etude de stabilite chimique pour la bupivacaine associee a l’hydromorphone et conditionnees dans des sacs de polychlorure de vinyle, et une etude de stabilite physique pour cette meme association medicamenteuse conditionnee dans des seringues de polypropylene. Objectif : Une etude de compatibilite physique et de stabilite chimique a ete menee pour determiner la duree de conservation qui permettrait de preparer par lots et de conserver dans des seringues de polypropylene cette association medicamenteuse, sans pertes significatives. Methodes : On a dilue de la bupivacaine (a 0,5 %) dans une solution physiologique salee (chlorure de sodium a 0,9 %) pour obtenir une solution a 0,25 %, qu’on a alors melangee a de l’hydromorphone pour obtenir une concentration finale de cette derniere de soit 0,02, soit 0,04 mg/mL. Ces preparations ont ensuite ete conditionnees dans des seringues de polypropylene et conservees soit a une temperature de 22 °C sous lumiere fluorescente, soit a une temperature de 6 °C a l’abri de la lumiere. On a preleve des echantillons de cinq millilitres de chaque seringue aux jours 0, 7, 14, 28, 56 et 91, qu’on a ensuite congeles a une temperature de –70 °C. Tous les echantillons ont ete examines pour un changement de couleur, de limpidite ou de pH, et soumis a une double analyse au moyen d’une epreuve de stabilite par chromatographie liquide a haute pression. Resultats : Tous les echantillons sont demeures incolores et n’ont presente aucun precipite tout au long de l’etude. On n’a observe aucun changement significatif du pH dans les deux conditions de stockage. Les melanges de bupivacaine (a 0,25 %) et d’hydromorphone (a 0,02 ou 0,04 mg/mL) conserves a une temperature de 22 °C avec exposition a la lumiere ou a une temperature de 6 °C a l’abri de la lumiere sont demeures stables pendant 91 jours. Conclusions : L’association bupivacaine (a 0,25 %) et hydromorphone (a 0,02 ou 0,04 mg/mL) conditionnee dans des seringues de polypropylene et conservee soit a une temperature de 22 °C avec exposition a la lumiere, soit a une temperature de 6 °C a l’abri de la lumiere a ete jugee stable pendant une periode d’au moins 91 jours. L’etablissement ou est rattache l’auteur a etabli une date de peremption de 30 jours, conformement a sa politique de conditionnement sterile. Les etablissements qui souhaitent utiliser l’information sur la compatibilite et la stabilite chimique presentee ici devraient d’abord mener leurs propres essais sur les conditionnements steriles qu’ils utilisent.
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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 | 0.002 |
| 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 | 0.001 |
| 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".