Stability of Ondansetron in Large-Volume Parenteral Solutions

1992 ◽  
Vol 26 (6) ◽  
pp. 768-771 ◽  
Author(s):  
C. Lynn Graham ◽  
George E. Dukes ◽  
Cheng-Fang Kao ◽  
Jeanne M. Bertch ◽  
Lawrence J. Hak
Keyword(s):  
Large Volume ◽  
Room Temperature ◽  
Design Method ◽  
Hplc Method ◽  
Significant Loss ◽  
Fluorescent Light ◽  
All Solutions ◽  
Ondansetron Hydrochloride ◽  
Clinically Significant ◽  
The Stability

OBJECTIVE: To determine the stability of ondansetron hydrochloride in large-volume parenteral solutions under four storage and time-period conditions. DESIGN/METHOD: Ondansetron was added to each of the following commercially available solutions to make final concentrations of approximately 24 and 96 μg/mL: NaCl 0.9%, D5W, and lactated Ringer's solution. SETTING: University analytical laboratory. MAIN OUTCOME MEASURES: Each solution was studied at both concentrations under the following conditions: (1) 1 day refrigerated, 2 days room temperature; (2) 7 days refrigerated, 2 days room temperature; (3) 14 days refrigerated, 2 days room temperature; and (4) 14 days room temperature. All solutions were exposed to fluorescent light when under room temperature conditions and were studied in triplicate. Ondansetron concentrations of samples were obtained periodically throughout each storage/time condition via a specific, stability-indicating HPLC method. RESULTS: A clinically significant loss of concentration was defined as >10 percent decrease from the initial concentration. In all solutions and at both concentrations studied, the mean ondansetron concentration was ≥90 percent under all storage and time conditions. CONCLUSIONS: Ondansetron can be stored and administered in these solutions without loss of potency.

Stability of Ondansetron Stored in Polypropylene Syringes

1994 ◽  
Vol 28 (6) ◽  
pp. 712-714 ◽  
Author(s):  
Daniel T. Casto
Keyword(s):  
Room Temperature ◽  
Storage Condition ◽  
Storage Conditions ◽  
Observation Time ◽  
Time Range ◽  
Ondansetron Hydrochloride ◽  
Drug Loss ◽  
Clinically Significant ◽  
The Stability ◽  
Sampling Times

OBJECTIVE: To evaluate the stability of ondansetron hydrochloride undiluted and mixed in dextrose 5% injection or NaCl 0.9% injection during storage in polypropylene syringes when frozen, refrigerated, or at room temperature. DESIGN: Batch quantities of ondansetron 0.25, 0.5, 1.0, and 2.0 mg/mL were prepared and individual doses of 10.5 mg were drawn into polypropylene syringes that were stored at −20 °C for up to 3 months, at 4 °C for up to two weeks, or at 22–25 °C for two days, and various combinations of these conditions. At defined sampling times aliquots were withdrawn from syringes, the solution visually inspected, pH measured, and ondansetron concentration determined by HPLC. Drug loss of ≥10 percent of the original content of the solution was considered clinically significant. RESULTS: The ondansetron concentration in each solution, regardless of storage conditions, remained above 90 percent of the original concentration at each observation time (range 92–107 percent). No changes in color or clarity of any of the solutions were observed, and only slight fluctuations in pH (≤0.05) were noted. CONCLUSIONS: Ondansetron 2 mg/mL undiluted, or at concentrations of 0.25, 0.5, or 1 mg/mL, mixed in dextrose 5% injection or NaCl 0.9% injection was determined to be stable when stored in polypropylene syringes for each storage condition at all time points studied, including the maximum for each: three months at −20 °C, followed by 14 days at 4 °C, and by 48 hours at 22–25 °C.

ANTIBIOTIC STABILITY IN SOLUTIONS USED FOR INTRAVENOUS NUTRITION AND FLUID THERAPY

PEDIATRICS ◽  
1973 ◽  
Vol 51 (6) ◽  
pp. 1016-1026
Author(s):  
Ralph D. Feigin ◽  
Kanneth S. Moss ◽  
Penelope G. Shackelford
Keyword(s):  
Antimicrobial Activity ◽  
Normal Saline ◽  
Protein Hydrolysate ◽  
Significant Degree ◽  
Significant Loss ◽  
All Solutions ◽  
Ringer’S Lactate ◽  
Series Of Experiments ◽  
The Stability ◽  
Crystalline Amino Acids

The present study was designed to assess the stability of ampicillin, carbenicillin, clindamycin, kanamycin, cephalothin, methicillin, and penicillin in three parenteral hyperalimentation mixtures as reconstituted for delivery to the patient in the clinical setting. Stability at 4C, 25C, and 37C was tested in parenteral hyperalimentation mixtures containing either crystalline amino acids or a protein hydrolysate. In two series of experiments the stability at 4C, 25C, and 37C of ampicillin, cephalothin, and kanamycin also was assessed in Isolyte M (ISO M), Isolyte P (ISO P), Ringer's lactate (LR), 5% dextrose in water, (D5W), 10% dextrose in water (D1OW), dextrose in normal saline (D5S), and normal saline (NS) to which hydrocortisone or heparin had been added. All antibiotics retained their effectiveness at an acceptable level in the hyperalimentation solutions at 4C. At 25C and 37C, all antibiotics except clindamycin lost activity by 24 hours. Kanamycin was least stable in these solutions and ampicillin also lost a significant degree of antimicrobial activity. Addition of heparin or hydrocortisone imparted stability to ampicillin in the seven parenteral solutions although significant loss of activity was noted at 37C in D5W, D1OW, D5S, and LR. Most solutions containing heparin or hydrocortisone and cephalothin turned yellow by 24 hours. A precipitate appeared in solutions containing heparin and kanamycin but there was minimal loss of antimicrobial activity. Kanamycin was stable in all solutions containing hydrocortisone except in D5W and D10W at 37C.

scholarly journals Stability Studies of Twenty-Four Analytes in Human Plasma and Serum

2002 ◽  
Vol 48 (12) ◽  
pp. 2242-2247 ◽  
Author(s):  
Bobby L Boyanton ◽  
Kenneth E Blick
Keyword(s):  
Blood Cells ◽  
Repeated Measures ◽  
Room Temperature ◽  
Stability Studies ◽  
Pump Failure ◽  
Glucose Depletion ◽  
Prolonged Contact ◽  
Biochemical Mechanisms ◽  
Clinically Significant ◽  
The Stability

Abstract Background: The stability and stoichiometric changes of analytes in plasma and serum after prolonged contact with blood cells in uncentrifuged Vacutainer® tubes were studied. Methods: We simultaneously investigated the stability of 24 analytes (a) after prolonged contact of plasma and serum with blood cells and (b) after immediate separation of plasma and serum (centrifuged twice at 2000g for 5 min). We verified biochemical mechanisms of observed analyte change by concomitant measurement of pH, Pco2, and Po2. Hemolysis was qualitatively and semiquantitatively assessed. All specimens were maintained at room temperature (25 °C) and analyzed in duplicate 0.5, 4, 8, 16, 24, 32, 40, 48, and 56 h after collection. Statistically significant changes from the 0.5 h mean were determined using repeated-measures ANOVA. The significant change limit was applied to determine clinically significant changes in measured analytes. Results: Fifteen of 24 analytes in plasma and serum maintained in contact with cells showed clinically relevant changes, with the degree of change more pronounced in most plasma specimens. All analytes in plasma and serum immediately separated from cells after collection were stable. Conclusion: Storage of uncentrifuged specimens beyond 24 h caused significant changes in most analytes investigated because of (a) glucose depletion and Na+,K+-ATPase pump failure; (b) the movement of water into cells, causing hemoconcentration; and (c) leakage of intracellular constituents and metabolites. Immediate separation of plasma or serum from cells provides optimal analyte stability at room temperature. When prolonged contact of plasma or serum with cells is unavoidable, use of serum is recommended because of the higher instability of plasma analytes.

Stability of Donepezil in an Extemporaneously Prepared Oral Liquid

2006 ◽  
Vol 19 (5) ◽  
pp. 282-285 ◽  
Author(s):  
Weeranuj Yamreudeewong ◽  
Eric Kurt Dolence ◽  
Deborah Pahl
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Storage Time ◽  
Microbial Growth ◽  
Storage Period ◽  
Significant Loss ◽  
Ambient Room Temperature ◽  
Oral Liquid ◽  
Liquid Preparation ◽  
The Stability

The stability of donepezil in an extemporaneously prepared oral liquid was studied. An aqueous liquid formulation of donepezil was prepared by reconstituting the powder from triturated 5-mg tablets with equal amounts of deionized water and 70% sorbitol solution with an expected donepezil concentration of 1 mg/mL. Polyethylene terephthalate plastic bottles containing donepezil liquid preparation were stored at ambient room temperature (22° C-26° C) and in the refrigerator (4° C-8° C). After a storage time of 1, 2, 3, and 4 weeks, donepezil liquid samples were analyzed in triplicate for donepezil concentrations by high-performance liquid chromatography. The concentrations of donepezil were found to be within the acceptable limit (± 10% of the initial concentration) in all test samples, which indicated that donepezil liquid preparation was stable at room temperature and in the refrigerator for up to 4 weeks. In addition, our study findings indicated that there was no microbial growth in the extemporaneously prepared donepezil liquid preparation after a storage period of 4 weeks in the refrigerator. In summary, the results of our study revealed that donepezil is stable (no significant loss of donepezil concentration and no microbial growth) in an extemporaneously prepared oral liquid when stored in the refrigerator for up to 4 weeks.

Stability of Amiodarone in an Oral Suspension Stored under Refrigeration and at Room Temperature

1997 ◽  
Vol 31 (7-8) ◽  
pp. 851-852 ◽  
Author(s):  
Milap C. Nahata
Keyword(s):  
Dosage Form ◽  
Room Temperature ◽  
Hplc Method ◽  
Oral Suspension ◽  
Storage Container ◽  
Three Samples ◽  
Two Temperatures ◽  
The Mean ◽  
The Stability ◽  
Tablet Dosage

OBJECTIVE: Amiodarone is currently available in a tablet dosage form, which cannot be used in young pediatric patients. The objective of our study was to determine the stability of amiodarone in an oral suspension stored at two temperatures. METHODS: Commercially available amiodarone tablets (200 mg each) were dissolved in purified water and a suspension prepared in methylcellulose 1 % and syrup to yield a concentration of 5 mg/mL. The dosage form was stored in 10 glass and 10 plastic prescription bottles. One-half of the bottles were stored at 4 °C and the others at 25 °C. Three samples were taken from each bottle at 0, 7, 14, 28, 42, 56. 70, and 91 days (n = 15). Amiodarone concentrations were measured by a validated and stability-indicating HPLC method; the pH was also determined in each sample. The drug was considered stable if its concentration exceeded 90% of the original concentration. RESULTS: The mean concentration of amiodarone was 90% or more at 4 °C for 91 days and at 25 °C for 42 days. The concentration was not affected by the type of storage container. Over 91 days, the pH did not change at 4 °C; it decreased slightly from 4.4 to 4.3 at 25 °C. CONCLUSIONS: Amiodarone was stable in an oral suspension for 3 months under refrigeration and for 6 weeks at room temperature.

scholarly journals Stability of hepatitis B virus pregenomic RNA in plasma specimens under various temperatures and storage conditions

PeerJ ◽  
2021 ◽  
Vol 9 ◽  
pp. e11207
Author(s):  
Pakkapon Rattanachaisit ◽  
Sirinporn Suksawatamnuay ◽  
Supachaya Sriphoosanaphan ◽  
Kessarin Thanapirom ◽  
Panarat Thaimai ◽  
...  
Keyword(s):  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Room Temperature ◽  
Plasma Samples ◽  
Freeze Thaw ◽  
B Virus ◽  
The Mean ◽  
Clinically Significant ◽  
The Stability ◽  
And Storage

Background Hepatitis B virus (HBV) pregenomic RNA (pgRNA) has gained increasing attention owing to its role in replication of covalently closed circular DNA (cccDNA) in HBV. This marker has the potential to be used in clinical programs aimed to manage HBV infections. However, several reports on HBV pgRNA levels in clinical cases have conflicting results. RNA is easily degraded when exposed to heat and other environmental stressors. However, the stability of HBV pgRNA, during blood sample collection before the standard automated quantification, has never been estimated. This study aimed to demonstrate the effect of two different temperature conditions and storage durations on the stability of HBV pgRNA. Method Blood from forty patients with chronic hepatitis B infection, who also showed evidence of active HBV DNA replication, was collected and processed within 2 h of collection. Plasma from each patient was divided and stored at 4 °C and 25 °C (room temperature) for six different storage durations (0, 2, 6, 12, 24, and 48 h) and subsequently transferred to −80 °C for storage. The effect of multiple cycles of freezing and thawing of plasma at −20 °C or −80 °C was evaluated using samples from ten patients. Quantification of pgRNA from the samples was performed simultaneously, using the digital polymerase chain reaction (dPCR) method. The differences in pgRNA levels at baseline and each time point were compared using generalized estimating equation (GEE). A change greater than 0.5 log10 copies/mL of pgRNA is considered clinically significant. Statistical analyses were conducted using Stata 16.0. Results The mean HBV pgRNA level in the initially collected plasma samples was 5.58 log10copies/mL (ranging from 3.08 to 8.04 log10 copies/mL). The mean pgRNA levels in samples stored for different time periods compared with the initial reference sample (time 0) significantly decreased. The levels of pgRNA for 6, 12, 24, and 48 h of storage reduced by −0.05 log10 copies/mL (95% confidence interval (CI) −0.095 to −0.005, p = 0.03), −0.075 log10 copies/mL (95% CI [−0.12 to −0.03], p = 0.001), −0.084 log10 copies/mL (95% CI [−0.13 to −0.039], p =  < 0.001), and −0.120 log10 copies/mL (95% CI [−0.17 to −0.076], p =  < 0.001), respectively. However, these changes were below 0.5 log10 copies/mL and thus were not clinically significant. Compared with the samples stored at 4 °C, there were no significant differences in pgRNA levels in samples stored at 25 °C for any of the storage durations (−0.01 log10 copies/mL; 95% CI [−0.708 to 0.689], p = 0.98). No significant difference in the levels of pgRNA was observed in the plasma samples, following four freeze-thaw cycles at −20 °C and −80 °C. Conclusion The plasma HBV pgRNA level was stable at 4 °C and at room temperature for at least 48 h and under multiple freeze-thaw cycles. Our results suggest that pgRNA is stable during the process of blood collection, and therefore results of pgRNA quantification are reliable.

Stability of a pyrimethamine suspension compounded from bulk powder

2017 ◽  
Vol 74 (24) ◽  
pp. 2060-2064 ◽  
Author(s):  
Paul O. Lewis ◽  
David B. Cluck ◽  
Jessica D. Huffman ◽  
Amanda P. Ogle ◽  
Stacy D. Brown
Keyword(s):  
High Performance ◽  
Room Temperature ◽  
Hplc Method ◽  
Stability Indicating ◽  
Color Changes ◽  
Stability Indicating Method ◽  
Bulk Powder ◽  
Subsequent Application ◽  
Temperature Ranges ◽  
The Stability

Abstract Purpose Development of a stability-indicating high-performance liquid chromatography (HPLC) method for pyrimethamine analysis, with subsequent application of that method to assess the 90-day stability of a pyrimethamine suspension compounded from bulk USP-grade pyrimethamine powder, is described. Methods A stability-indicating method of HPLC with ultraviolet detection specific to pyrimethamine was developed according to pharmacopeial recommendations and validated. The method was applied to investigate the stability of a 2-mg/mL pyrimethamine suspension in a vehicle consisting of Ora-Plus and Ora-Sweet (Perrigo) over a period of 90 days. Three replicate test preparations were stored at room temperature or refrigerated at 4.3–5.2 °C, and samples were analyzed in duplicate immediately after preparation and on study days 1, 2, 4, 7, 10, 14, 21, 30, 48, 60, 75, and 90. Results The 2-mg/mL suspension of pyrimethamine in Ora-Plus and Ora-Sweet retained 90–110% of the labeled potency to 90 days at both temperature ranges. However, color changes in the samples stored at room temperature observed at day 60 indicated that a beyond-use date less than 90 days from the preparation date should be specified when the suspension is to be stored at room temperature. Conclusion The study demonstrated that USP-grade pyrimethamine powder can be formulated as a 2-mg/mL suspension in a vehicle of Ora-Plus and Ora-Sweet and is stable when stored at room temperature and when refrigerated, in amber plastic bottles, for 48 and 90 days, respectively.

Stability Study of Epirubicin in Nacl 0.9% Injection

1997 ◽  
Vol 31 (9) ◽  
pp. 992-995 ◽  
Author(s):  
Montserrat Pujol ◽  
Montserrat Muñoz ◽  
Josefina Prat ◽  
Victoria Girona ◽  
Jordi De Bolós
Keyword(s):  
Shelf Life ◽  
Room Temperature ◽  
Degradation Kinetics ◽  
Storage Conditions ◽  
Hplc Method ◽  
Stability Study ◽  
Chemistry Laboratory ◽  
Maximum Decrease ◽  
Different Temperatures ◽  
The Stability

Objective To determine the stability of epirubicin in NaCl 0.9% injection under hospital storage conditions. Methods NaCl 0.9% solution was added to epirubicin iyophilized powder to make a final concentration of 1 mg/mL to study the degradation kinetics and 2 mg/mL to study the stability in polypropylene syringes under hospital conditions. Setting Physical chemistry laboratory, Unitat de Fisicoquímica, Universitat de Barcelona. Main outcome Measures Solutions of epirubicin at 2 mg/mL in NaCl 0.9% solutions stored in plastic syringes were studied under hospital conditions at room temperature (25 ± 1 °C) and under refrigeration (4 ± 1 °C) both protected from light and exposed to room light (~50 lumens/m2). All samples were studied in triplicate and epirubicin concentrations were obtained periodically throughout each storage/time condition via a specific stability-indicating HPLC method. To determine the degradation kinetics, solutions of epirubicin in NaCl 0.9% at 1 mg/mL were stored at different temperatures (40, 50, and 60 °C) to obtain the rate degradation constant and the shelf life at room temperature and under refrigeration. Results The degradation of epirubicin in NaCl 0.9% solutions follows first-order kinetics. The shelf life was defined as the time by which the epirubicin concentration had decreased by 10% from the initial concentration. In this study, epirubicin was stable in NaCl 0.9% injection stored in polypropylene containers for all time periods and all conditions. That results in a shelf life of at least 14 and 180 days at 25 and 4 °C, respectively. The maximum decrease in epirubicin concentration observed at 25 °C and 14 days was 4%, and at 4 °C and 180 days was 8%. The predicted shelf life obtained from the Arrhenius equation was 72.9 ± 0.2 and 3070 ± 15 days at 25 and 4 °C, respectively, in both dark and illuminated conditions. Conclusions Solutions of epirubicin in NaCl 0.9% at 2 mg/mL are chemically stable when they are stored in polypropylene syringes under hospital storage conditions. No special precaution is neccessary to protect epirubicin solutions (2 mg/mL) from light.

scholarly journals Overcoming Supply Shortage for SARS-CoV-2 Detection by RT-qPCR

Genes ◽  
2021 ◽  
Vol 12 (1) ◽  
pp. 90
Author(s):  
Gustavo Barcelos Barra ◽  
Ticiane Henriques Santa Rita ◽  
Pedro Góes Mesquita ◽  
Rafael Henriques Jácomo ◽  
Lídia Freire Abdalla Nery
Keyword(s):  
Room Temperature ◽  
Limit Of Detection ◽  
Guanidine Hydrochloride ◽  
Significant Loss ◽  
Clinical Samples ◽  
Short Supply ◽  
Qualitative Detection ◽  
Probe Concentration ◽  
Assay Performance ◽  
The Stability

In February 2020, our laboratory started to offer a RT-qPCR assay for the qualitative detection of severe acute respiratory syndrome coronavirus 2. A few months after the assay was released to our patients, some materials, reagents, and equipment became in short supply. Alternative protocols were necessary in order to avoid stopping testing to the population. However, the suitability of these alternatives needs to be validated before their use. Here, we investigated if saliva is a reliable alternative specimen to nasopharyngeal swabs; if 0.45% saline is a reliable alternative to guanidine hydrochloride as a collection viral transport media; the stability of SARS-COV-2 in guanidine hydrochloride and in 0.45% saline for 10 and 50 days at room temperature; and if the primers/probe concentration and thermocycling times could be reduced so as to overcome the short supply of these reagents and equipment, without a significant loss of the assay performance. We found that saliva is not an appropriated specimen for our method—nasopharyngeal swabs perform better. Saline (0.45%) and guanidine hydrochloride have a similar SARS-CoV-2 diagnostic capability as tube additives. Reliable SARS-CoV-2 RNA detection can be performed after sample storage for 10 days at room temperature (18–23 °C) in both 0.45% saline and guanidine hydrochloride. Using synthetic RNA, and decreasing the concentration of primers by five-fold and probes by 2.5-fold, changed the assay limit of detection (LOD) from 7.2 copies/reaction to 23.7 copies/reaction and the subsequent reducing of thermocycling times changed the assay LOD from 23.7 copies/reaction to 44.2 copies/reaction. However, using real clinical samples with Cq values ranging from ~12.15 to ~36.46, the results of the three tested conditions were almost identical. These alterations will not affect the vast majority of diagnostics and increase the daily testing capability in 30% and increase primers and probe stocks in 500% and 250%, respectively. Taken together, the alternative protocols described here overcome the short supply of tubes, reagents and equipment during the SARS-CoV-2 pandemic, avoiding the collapse of test offering for the population: 105,757 samples were processed, and 25,156 SARS-CoV-2 diagnostics were performed from 9 May 2020 to 30 June 2020.

scholarly journals Stability of Levodopa/Carbidopa Rectal Suspensions

2016 ◽  
Vol 51 (11) ◽  
pp. 915-921 ◽  
Author(s):  
Ronald F. Donnelly
Keyword(s):  
High Performance Liquid Chromatography ◽  
High Performance ◽  
Oropharyngeal Dysphagia ◽  
Rectal Administration ◽  
Hplc Method ◽  
Physical Parameters ◽  
Time Period ◽  
All Solutions ◽  
Time Periods ◽  
The Stability

Objective The combination of levodopa and carbidopa (L/C) is used as an effective therapy for treating Parkinson's disease; however when oropharyngeal dysphagia develops or when insertion of an nasogastric tube is not possible, then rectal administration could be used. To reduce compounding workload and establish a beyond use date, this study was conducted to determine the stability of 2 L/C rectal suspension formulations when stored at either 22°C or 5°C. Methods Two formulations of L/C rectal suspension were compounded and then packaged in amber polypropylene bottles. Three bottles of each formulation were stored at either 22°C or 5°C and analyzed at 11 time periods. Physical parameters such as caking, ease of resuspending, and pH were also determined at each time period. A validated stability-indicating high-performance liquid chromatography (HPLC) method was used to analyze both active ingredients. Results All solutions were easy to resuspend, there were no signs of caking, and there was no significant change in pH over the 35 days of storage at either temperature. The glycerin-based formulation (formulation 1) was less stable at 22°C (10 days) than formulation 2 (24 days). Both rectal suspensions were stable for 35 days when stored at 5°C. Conclusions The physical compatibility and chemical stability of 2 formulations of L/C rectal suspension packaged in amber polypropylene bottles was determined to be either 10 or 24 days when stored at 22°C or 35 days at 5°C.

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