ArticleJournal of diabetes science and technology2018
Insulin Concentration in Vials Randomly Purchased in Pharmacies in the United States: Considerable Loss in the Cold Supply Chain.
Article in Journal of diabetes science and technology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
17 citing papers in PubMed.
- Towards the development of an insulin degradation test.bioRxiv : the preprint server for biology · 2026Article
- Towards the Development of an Insulin Degradation Test.Journal of diabetes research · 2026Article
- Regulatory Verification by Health Canada of Content in Recombinant Human Insulin, Human Insulin Analog, and Porcine Insulin Drug Products in the Canadian Market Using Validated Pharmacopoeial Methods Over Nonvalidated Approaches.Journal of diabetes science and technology · 2024Article
- Closed loop insulin delivery-Opportunities and limitations.Journal of diabetes · 2023Article
- The Nuances Surrounding Insulin Prescribing.Clinical diabetes : a publication of the American Diabetes Association · 2023Article
- Subcutaneous amyloidoma models for screening potential anti-fibrillating agents in vivo.STAR protocols · 2021Article
- Quality Assurance of Commercial Insulin Formulations: Novel Assay Using Infrared Spectroscopy.Journal of diabetes science and technology · 2021Article
- Assessment of Regular and NPH Insulin Concentration via Two Methods of Quantification: The Washington State Insulin Concentration Study (WICS).Journal of diabetes science and technology · 2021Article
- Systematic stability testing of insulins as representative biopharmaceuticals using ATR FTIR-spectroscopy with focus on quality assurance.Journal of biomedical optics · 2021Article
- Capacity of Infusion Lines for Insulin Adsorption: Effect of Flow Rate on Total Adsorption.Journal of diabetes science and technology · 2021Article
- Insulin Storage: A Critical Reappraisal.Journal of diabetes science and technology · 2021Article
- Commercially Available Insulin Products Demonstrate Stability Throughout the Cold Supply Chain Across the U.S.Diabetes care · 2020Article
- NMR Spectroscopic Analysis to Evaluate the Quality of Insulin: Concentration, Variability, and Excipient Content.Journal of diabetes science and technology · 2020Article
- Concentrations of Intact Insulin Concurs With FDA and EMA Standards When Measured by HPLC in Different Parts of the Distribution Cold Chain.Journal of diabetes science and technology · 2019Article
- Lilly Calls into Question the Validity of Published Insulin Concentration Results.Journal of diabetes science and technology · 2018Article
- In Response to Carter and Heinemann: Insulin Concentration in Vials Randomly Purchased in Pharmacies in the United States: Considerable Loss in the Cold Supply Chain.Journal of diabetes science and technology · 2018Article
- Addressing Challenges in Insulin Storage: An Ethical Dilemma among Physicians.Indian journal of endocrinology and metabolismArticle
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The insulin content in vials/cartridges should be 95 U/ml upon release. No independent confirmation of insulin concentration is available when purchased in the pharmacy (end of the cold supply chain). We quantitatively measured intact insulin in randomly acquired multidose human insulin vials by standard analytical methods. Eighteen 10 ml vials from two manufacturers (M1 and M2) were randomly acquired. The intact insulin concentration ranged from 13.9 to 94.2 U/ml, mean 40.2 U/ml. No vial met the minimum standard of 95 U/ml. These results imply the cold supply chain impacts insulin concentrations to a larger extent than anticipated. Patients are paying high prices for insulin and should expect to receive insulin vials with adequate insulin content in return.
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Registered trials
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