Stability of Five Antibiotics

The stability of methicillin, amikacin, erythromycin lactobionate, vancomycin, and ticarcillin in plastic intravenous containers of sodium chloride injection 0.9%, USP and dextrose 5% injection, USP was studied. The study was conducted under aseptic conditions for a period of 24 hours. The samples, drawn at various times, were assayed by a modified agar gel diffusion technique. The study solutions were stored at room temperature. This study revealed that amikacin, methicillin, vancomycin, and ticarcillin are stable for 24 hours in the test solutions. Erythromycin lactobionate is stable for 24 hours in normal saline, but the addition of sodium bicarbonate 4% (Neut®) was necessary to assure stability in dextrose 5 %.

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Extended Stability of Epinephrine Hydrochloride Injection in Polyvinyl Chloride Bags Stored in Amber Ultraviolet Light–Blocking Bags

Hospital Pharmacy ◽

10.1177/0018578717721121 ◽

2017 ◽

Vol 52 (8) ◽

pp. 570-573

Author(s):

Edward T. Van Matre ◽

Kang C. Ho ◽

Clark Lyda ◽

Beth A. Fullmer ◽

Alan R. Oldland ◽

...

Keyword(s):

Sodium Chloride ◽

Ultraviolet Light ◽

Polyvinyl Chloride ◽

High Performance ◽

Room Temperature ◽

Physical Stability ◽

Three Samples ◽

The Stability ◽

Aseptic Conditions ◽

And Storage

Objective: The objective of this study was to evaluate the stability of epinephrine hydrochloride in 0.9% sodium chloride in polyvinyl chloride bags for up to 60 days. Methods: Dilutions of epinephrine hydrochloride to concentrations of 16 and 64 µg/mL were performed under aseptic conditions. The bags were then placed into ultraviolet light–blocking bags and stored at room temperature (23°C-25°C) or under refrigeration (3°C-5°C). Three samples of each preparation and storage environment were analyzed on days 0, 30, 45, and 60. Physical stability was performed by visual examination. The pH was assessed at baseline and upon final degradation evaluation. Sterility of the samples was not assessed. Chemical stability of epinephrine hydrochloride was evaluated using high-performance liquid chromatography. To determine the stability-indicating nature of the assay, degradation 12 months following preparation was evaluated. Samples were considered stable if there was less than 10% degradation of the initial concentration. Results: Epinephrine hydrochloride diluted to 16 and 64 µg/mL with 0.9% sodium chloride injection and stored in amber ultraviolet light–blocking bags was physically stable throughout the study. No precipitation was observed. At days 30 and 45, all bags had less than 10% degradation. At day 60, all refrigerated bags had less than 10% degradation. Overall, the mean concentration of all measurements demonstrated less than 10% degradation at 60 days at room temperature and under refrigeration. Conclusion: Epinephrine hydrochloride diluted to 16 and 64 µg/mL with 0.9% sodium chloride injection in polyvinyl chloride bags stored in amber ultraviolet light–blocking bags was stable up to 45 days at room temperature and up to 60 days under refrigeration.

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Physicochemical stability of pembrolizumab admixture solution in normal saline intravenous infusion bag

Journal of Oncology Pharmacy Practice ◽

10.1177/1078155219868516 ◽

2019 ◽

Vol 26 (3) ◽

pp. 641-646 ◽

Cited By ~ 2

Author(s):

Prakash Sundaramurthi ◽

Sean Chadwick ◽

Chakravarthy Narasimhan

Keyword(s):

Normal Saline ◽

Intravenous Infusion ◽

Room Temperature ◽

Extended Period ◽

End User ◽

Physicochemical Stability ◽

Diluted Solution ◽

Aseptic Conditions ◽

Physical Instability

Introduction Pembrolizumab is an anti-PD-1 monoclonal antibody, approved and under development for numerous indications in oncology. It is available as either lyophilized powder for reconstitution or ready-to-use solution. Both are required to be diluted in saline or dextrose solution prior to intravenous infusion. After dilution, the recommendation per summary of product characteristics is 24 h at 2–8℃ and 6 h at room temperature. The purpose of this study was to investigate the physicochemical stability of pembrolizumab diluted solution (1 mg/mL) at both refrigerated and room temperature conditions for an extended period. Methods Under aseptic conditions, pembrolizumab was diluted in 250 mL of saline injection in polyolefin bags to obtain the final protein concentration of 1 mg/mL. Thus, prepared bags were then stored at either 5℃ ± 3℃, refrigerator exposing the product to ambient light or room temperature (20℃ ± 3℃) on the benchtop. Results Using several analytical methods, it was demonstrated that pembrolizumab solution for infusion, diluted in normal saline can be stored in polyolefin infusion bags for at least 1 week at 5℃ or RT with no evidence of chemical or physical instability. No aggregation was observed. Conclusion Thus, the practical use of aseptically prepared diluted pembrolizumab in saline can be safely extended to optimize the workload of centralized preparation units and to minimize costs. However, it is the responsibility of the end-user to maintain overall quality of prepared admixture solution that is administered to patient, by following aseptic compounding process as recommended in the packaging insert.

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Stability of Extemporaneously Prepared Lansoprazole Suspension at Two Temperatures

The Journal of Pediatric Pharmacology and Therapeutics ◽

10.5863/1551-6776-18.2.122 ◽

2013 ◽

Vol 18 (2) ◽

pp. 122-127 ◽

Cited By ~ 1

Author(s):

Jordan T. Morrison ◽

Ralph A. Lugo ◽

Jim C. Thigpen ◽

Stacy D. Brown

Keyword(s):

Sodium Bicarbonate ◽

Room Temperature ◽

Internal Standard ◽

Storage Condition ◽

Significant Difference ◽

Expiration Time ◽

Liquid Chromatography Tandem Mass ◽

Two Temperatures ◽

The Stability ◽

Oral Sodium

OBJECTIVE The purpose of this study was to examine the stability of a generic lansoprazole product in a 3 mg/mL sodium bicarbonate suspension under room temperature and refrigerated conditions. METHODS Lansoprazole suspensions (3 mg/mL) were prepared in triplicate using an 8.4% sodium bicarbonate vehicle for each storage condition (room temperature and refrigerated). During 1 month, samples from each replicate were periodically removed and analyzed for lansoprazole concentration by liquid chromatography–tandem mass spectrometry (LC-MS/MS). Each sample was spiked with 10 mg/L omeprazole to serve as the internal standard. A positive electrospray LC-MS/MS method was validated over the calibration range of 5 to 25 mg/L using Food and Drug Administration Guidance. The identities of the analyte and internal standard in the samples were verified by monitoring the MS/MS transitions of m/z 370 to m/z 252 and m/z 346 to m/z 198 for lansoprazole and omeprazole, respectively. Additionally, the pH of the suspensions was monitored throughout the study. RESULTS The stability of lansoprazole in the oral sodium bicarbonate suspension under refrigeration is compromised prior to what has been previously reported in the literature. Samples kept at room temperature lost >10% of the lansoprazole after 48 hours compared with the refrigerated samples, which maintained integrity up to 7 days. No statistically significant difference was found between the pH of the room temperature and refrigerated suspension samples, indicating that this factor is not the cause for the differences in stability at these two conditions. CONCLUSIONS This study suggests that the extemporaneously compounded lansoprazole oral suspension prepared in 8.4% sodium bicarbonate should not be stored in plastic oral syringes longer than 48 hours at room temperature and no longer than 7 days when refrigerated. These data indicate an expiration time earlier than that previously reported for the refrigerated product (14 days).

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The Separation of Insect Haemolymph Proteins

The Canadian Entomologist ◽

10.4039/ent96110b-1 ◽

1964 ◽

Vol 96 (1-2) ◽

pp. 110-110

Author(s):

B. G. Loughton ◽

P. Rueffel ◽

H. Stich ◽

A. S. West

Keyword(s):

Amino Acid ◽

Gel Electrophoresis ◽

Starch Gel Electrophoresis ◽

Homologous Proteins ◽

Agar Gel ◽

Diffusion Technique ◽

Starch Gel ◽

Rapid Characterization ◽

Gel Diffusion

It has been suggested that information on the phylogenetic relationships of genera and species could be obtained by comparing the amino acid sequence in the homologous proteins of different species. This procedure is extremely difficult and time-consuming.However, a relatively rapid characterization of proteins can be obtained by analysing their mobilities with starch-gel electrophoresis and examination of antigenic diversity by the agar gel diffusion technique of Ouchterlony.

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A STUDY OF THE ANTIGENS INVOLVED IN ADENOVIRUS 12 TUMORIGENESIS BY IMMUNODIFFUSION TECHNIQUES

Journal of Experimental Medicine ◽

10.1084/jem.121.6.955 ◽

1965 ◽

Vol 121 (6) ◽

pp. 955-967 ◽

Cited By ~ 25

Author(s):

Leonard D. Berman ◽

Wallace P. Rowe

Keyword(s):

Tumor Antigen ◽

Tumor Antigens ◽

Neutralizing Antibody ◽

Classical Type ◽

Agar Gel ◽

Culture Cells ◽

Diffusion Technique ◽

Antibody Titers ◽

Infectious Cycle ◽

Gel Diffusion

The use of the agar gel diffusion technique has established the presence of three distinct antigenic reactions in the sera of Ad. 12 tumor-bearing hamsters. Only one of these antigens is directly demonstrable in the tumor. This "tumor" antigen is also formed during early stages of the infectious cycle in tissue culture cells. Other antigens present in the tumor, but only demonstrable indirectly with the use of antibody-containing serum of tumored hamsters, are the classical type-specific C antigen, and a new antigen, termed D. Of ninety-eight Ad. 12 tumored hamster sera, six reacted in gel diffusion with virus and tumor preparations, and thirty-one with tumor only. Sera which reacted in gel diffusion with viral antigen uniformly bad neutralizing antibody and high titers of CF antibody against viral and tumor antigens; however, many sera with comparable antibody titers did not react with the virus in gel diffusion. Sera which reacted in gel diffusion only with tumor antigen also had high CF antibody titers, but there was no correlation with neutralizing antibody.

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Stability of bicarbonate in normal saline: a technical report

Critical Care and Resuscitation ◽

10.51893/2020.1.tn2 ◽

2020 ◽

Vol 22 (1) ◽

Author(s):

Thummaporn Naorungroj ◽

◽

Ary Serpa Neto ◽

Briony Jude ◽

Andrew Udy ◽

...

Keyword(s):

Sodium Bicarbonate ◽

Normal Saline ◽

Rate Of Change ◽

Bicarbonate Concentration ◽

Severe Metabolic Acidosis ◽

Double Blind ◽

Hourly Rate ◽

Technical Report ◽

The Stability ◽

Intravenous Sodium

BACKGROUND: The benefit of intravenous sodium bicarbonate administration in patients with severe metabolic acidosis remains controversial, partly due to lack of double-blind trials. From a practical viewpoint, such blinding requires testing of the stability of sodium bicarbonate in polyolefin bags. METHODS: We examined seven samples of 100 mL 8.4% sodium bicarbonate diluted in 150 mL normal saline within a 250 mL polyolefin bag at time 0, 24 and 48 hours after preparation. We measured pH, Pco2, and bicarbonate concentration. RESULTS: Over a period of 48 hours, both pH and Pco2 decreased significantly (hourly rate of change, -0.001 [P = 0.043] and -0.098 [P < 0.001] respectively). However, the concentration of bicarbonate did not decrease, with an hourly rate of change of only -0.009 (P = 0.42). CONCLUSION: When 100 mL of 8.4% sodium bicarbonate are diluted in 150 mL of normal saline within a 250 mL polyolefin bag, changes in pH and Pco2 over a 48-hour period are small and bicarbonate concentration remains stable.

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