Stability of Sodium Pentobarbital 5w/v% Aqueous Solution During Short‐Term Chilled and Ambient‐Temperature Storage

ABSTRACT The COVID‐19 pandemic made it difficult to obtain pharmaceutical‐grade injectable anaesthetics used in animal experiments in Japan. To address this problem, it is worth the effort to evaluate whether the use of non‐pharmaceutical‐grade sodium pentobarbital (PBNa) water solution can be an al...

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Main Authors: Masakazu Dohi, Kayoko Ueda, Yoshinori Yamagiwa, Atsuko Yamashita, Yuji Sakamoto
Format: Article
Language:English
Published: Wiley 2024-11-01
Series:Veterinary Medicine and Science
Subjects:
Online Access:https://doi.org/10.1002/vms3.70066
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author Masakazu Dohi
Kayoko Ueda
Yoshinori Yamagiwa
Atsuko Yamashita
Yuji Sakamoto
author_facet Masakazu Dohi
Kayoko Ueda
Yoshinori Yamagiwa
Atsuko Yamashita
Yuji Sakamoto
author_sort Masakazu Dohi
collection DOAJ
description ABSTRACT The COVID‐19 pandemic made it difficult to obtain pharmaceutical‐grade injectable anaesthetics used in animal experiments in Japan. To address this problem, it is worth the effort to evaluate whether the use of non‐pharmaceutical‐grade sodium pentobarbital (PBNa) water solution can be an alternative one from the perspective of stability, physicochemical properties, bioavailability and so on. In this article, as a first step, we examined the stability of PBNa 5w/v% aqueous solution (PBNa 5% AS). PBNa 5% AS sample was prepared simply by dissolving non‐pharmaceutical‐grade PBNa into water and was stored at 25°C and 5°C for 15 days. Visual appearance, pH, osmolality and assay (contents of PBNa and related substances) were tested. The stability test results indicated that there was no profound change in these test items of the PBNa 5% AS under either storage condition, suggesting that the formulation was sufficiently stable in such a short term. The only observable change was an increase of an impurity under 25°C storage; however, it was at a negligible level. Moreover, as the pH of the formulation remained <10.0 throughout the storage period in both conditions, the irritant level of the pH is considered to be acceptable. Therefore, from the viewpoint of the stability and physicochemical properties, PBNa 5% AS can be an alternative injectable anaesthetic when access to pharmaceutical‐grade anaesthetics is limited, as long as used in short‐term from its preparation.
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spelling doaj-art-f1e13794be944bef9be27c735fa7d11d2025-01-20T17:16:45ZengWileyVeterinary Medicine and Science2053-10952024-11-01106n/an/a10.1002/vms3.70066Stability of Sodium Pentobarbital 5w/v% Aqueous Solution During Short‐Term Chilled and Ambient‐Temperature StorageMasakazu Dohi0Kayoko Ueda1Yoshinori Yamagiwa2Atsuko Yamashita3Yuji Sakamoto4Central Research Laboratories, Research & Development Division Senju Pharmaceutical Co. Ltd. Kobe Hyogo JapanCentral Research Laboratories, Research & Development Division Senju Pharmaceutical Co. Ltd. Kobe Hyogo JapanCentral Research Laboratories, Research & Development Division Senju Pharmaceutical Co. Ltd. Kobe Hyogo JapanCentral Research Laboratories, Research & Development Division Senju Pharmaceutical Co. Ltd. Kobe Hyogo JapanCentral Research Laboratories, Research & Development Division Senju Pharmaceutical Co. Ltd. Kobe Hyogo JapanABSTRACT The COVID‐19 pandemic made it difficult to obtain pharmaceutical‐grade injectable anaesthetics used in animal experiments in Japan. To address this problem, it is worth the effort to evaluate whether the use of non‐pharmaceutical‐grade sodium pentobarbital (PBNa) water solution can be an alternative one from the perspective of stability, physicochemical properties, bioavailability and so on. In this article, as a first step, we examined the stability of PBNa 5w/v% aqueous solution (PBNa 5% AS). PBNa 5% AS sample was prepared simply by dissolving non‐pharmaceutical‐grade PBNa into water and was stored at 25°C and 5°C for 15 days. Visual appearance, pH, osmolality and assay (contents of PBNa and related substances) were tested. The stability test results indicated that there was no profound change in these test items of the PBNa 5% AS under either storage condition, suggesting that the formulation was sufficiently stable in such a short term. The only observable change was an increase of an impurity under 25°C storage; however, it was at a negligible level. Moreover, as the pH of the formulation remained <10.0 throughout the storage period in both conditions, the irritant level of the pH is considered to be acceptable. Therefore, from the viewpoint of the stability and physicochemical properties, PBNa 5% AS can be an alternative injectable anaesthetic when access to pharmaceutical‐grade anaesthetics is limited, as long as used in short‐term from its preparation.https://doi.org/10.1002/vms3.70066anaesthetics agentschemical analysiseuthanasiapentobarbital
spellingShingle Masakazu Dohi
Kayoko Ueda
Yoshinori Yamagiwa
Atsuko Yamashita
Yuji Sakamoto
Stability of Sodium Pentobarbital 5w/v% Aqueous Solution During Short‐Term Chilled and Ambient‐Temperature Storage
Veterinary Medicine and Science
anaesthetics agents
chemical analysis
euthanasia
pentobarbital
title Stability of Sodium Pentobarbital 5w/v% Aqueous Solution During Short‐Term Chilled and Ambient‐Temperature Storage
title_full Stability of Sodium Pentobarbital 5w/v% Aqueous Solution During Short‐Term Chilled and Ambient‐Temperature Storage
title_fullStr Stability of Sodium Pentobarbital 5w/v% Aqueous Solution During Short‐Term Chilled and Ambient‐Temperature Storage
title_full_unstemmed Stability of Sodium Pentobarbital 5w/v% Aqueous Solution During Short‐Term Chilled and Ambient‐Temperature Storage
title_short Stability of Sodium Pentobarbital 5w/v% Aqueous Solution During Short‐Term Chilled and Ambient‐Temperature Storage
title_sort stability of sodium pentobarbital 5w v aqueous solution during short term chilled and ambient temperature storage
topic anaesthetics agents
chemical analysis
euthanasia
pentobarbital
url https://doi.org/10.1002/vms3.70066
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AT kayokoueda stabilityofsodiumpentobarbital5wvaqueoussolutionduringshorttermchilledandambienttemperaturestorage
AT yoshinoriyamagiwa stabilityofsodiumpentobarbital5wvaqueoussolutionduringshorttermchilledandambienttemperaturestorage
AT atsukoyamashita stabilityofsodiumpentobarbital5wvaqueoussolutionduringshorttermchilledandambienttemperaturestorage
AT yujisakamoto stabilityofsodiumpentobarbital5wvaqueoussolutionduringshorttermchilledandambienttemperaturestorage