Chemical stability of diphenhydramine hydrochloride in minibags and polypropylene
Bibliographic record
Abstract
ABSTRACT Solutions of diphenhydramine hydrochloride (12.5, 25, and 50 mg/50 mL) were prepared, in duplicate, in minibags containing dextrose 5% in water (D5W) or 0.9% sodium chloride (NS) and stored at either 22°C or 4°C, protected from light, for 91 days. Samples were taken from each minibag on days 0, 1, 3, 7, 14, 30, 59, and 91 and frozen at -72°C. Solutions of diphenhydramine hydrochloride (12.5, 25, and 50 mg/10 mL) were prepared in NS and packaged in polypropylene syringes, in triplicate, and sealed with friction caps. The syringes were stored at either 22°C or 4°C, protected from light, for 28 days. Samples were collected from each syringe on days 0, 1, 3, 7, 14, 22, and 28 and frozen at -72°C. All samples were analyzed in duplicate with a stability-indicating high-pressure liquid chromatography assay. All chemical stability samples remained colourless and free of precipitate throughout the course of the study. The concentration of all diphenhydramine solutions was greater than 90%, of the initial concentration over the entire study period for all diluents and storage temperatures studied. Diphenhydramine hydrochloride solutions diluted to concentrations of 12.5, 25, and 50 mg/50 mL with D5W or NS were considered chemically stable for at least 91 days when stored at either 22°C or 4°C and protected from light. Solutions of diphenhydramine diluted to 12.5, 25, and 50 mg/10 mL with NS, packaged in polypropylene syringes, and sealed with friction caps were considered stable for at least 28 days when stored at either 22°C or 4°C and protected from light. RESUME Des solutions de chlorhydrate de diphenhydramine (12,5, 25, et 50 mg/50 ml) ont ete preparees, en deux exemplaires, dans des minisacs contenant du dextrose a 5 % dans l'eau (D5W) ou du chlorure de sodium a 0,9 % (NS), puis entreposees a des temperatures de 22°c ou de 4°C, a l'abri de la lumiere, et ce pendant 91 jours. Des echantillons ont ete preleves de chaque minisac aux jours 0, 1, 3, 7, 14, 30, 59, et 91 et congeles a une temperature de -72°C. Les solutions de chlorhydrate de diphenhydramine (12,5, 25, et 50 mg/10 mL) ont ete preparees dans du NS et conditionnees dans des seringues de polypropylene, en trois exemplaires, puis scellees avec des capuchons a friction. Les seringues ont ete entreposees a une temperature de 22°C ou de 4°C, protegees de la lumiere, et ce pendant 28 jours. Des echantillons ont ete preleves de chaque seringue aux jours 0, 1, 3, 7, 14, 22, et 28, puis congelees a une temperature de -72°C. Tous les echantillons ont ete analyses en double a l'aide d'une epreuve de stabilite par chromatographie liquide a haute pression. Tous les echantillons pour l’analyse de la stabilite chimique sont demeures incolores et sans precipite pendant toute la duree de l'etude. La concentration de toutes les solutions de diphenhydramine etait superieure a 90 % des concentrations initiales pendant toute la duree de l'etude, et ce pour tous les diluants et a toutes les temperatures d'entreposage. Les solutions de chlorhydrate de diphenhydramine diluees a des concentrations de 12,5, 25, et 50 mg/50 mL avec du D5W ou du NS ont ete considerees comme etant chimiquement stables pendant une periode d'au moins 91 jours lorsqu'entreposees a des temperatures de 22°C ou de 4°c et protegees de la lumiere. Les solutions de diphenhydramine diluees a 12,5, 25, et 50 mg/10 mL avec du NS, conditionnees dans des seringues de polypropylene, et scellees avec capuchons a friction ont ete considerees comme stables pendant au moins 28 jours lorsqu'entreposees a des temperatures de 22°C ou de 4°C et protegees de la lumiere.
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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 | 0.001 |
| 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 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| 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".