Comparison of the Purity and Impurity of Glucagon-for-Injection Products under Various Stability Conditions
Glucagon is a polypeptide hormone that serves as an essential therapeutic agent in the emergency treatment of hypoglycemia. Recently, the first generic glucagon for injection was approved. However, unlike its brand name counterpart, which is produced via recombinant DNA, the generic glucagon is prod...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-05-01
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| Series: | Scientia Pharmaceutica |
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| Online Access: | https://www.mdpi.com/2218-0532/90/2/32 |
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| author | Zhongli Bao Ya-Chi Cheng Mary Ziping Luo Jack Yongfeng Zhang |
| author_facet | Zhongli Bao Ya-Chi Cheng Mary Ziping Luo Jack Yongfeng Zhang |
| author_sort | Zhongli Bao |
| collection | DOAJ |
| description | Glucagon is a polypeptide hormone that serves as an essential therapeutic agent in the emergency treatment of hypoglycemia. Recently, the first generic glucagon for injection was approved. However, unlike its brand name counterpart, which is produced via recombinant DNA, the generic glucagon is produced using a chemical synthesis method. Regardless of its origin, impurities may occur in both glucagon drug products. While these impurities may greatly compromise the safety and efficacy of the glucagon drug products, studies accessing the impurities of glucagon for injection are limited. This manuscript analyzed the stability and impurities of a generic and brand glucagon for injection, including desamido and non-desamido impurities, under various storage and temperature conditions using an ultra-performance liquid chromatography method. The glucagon products were analyzed after 6 and 24 months of storage under room temperatures (20–25 °C). In addition, the products were also assessed after 6 months of storage under high temperatures (40 °C). Under each stability storage condition, three lots of the synthetic glucagon were evaluated by UPLC with at least one lot of the recombinant glucagon for comparison. A total of 37 peaks were identified (except for the solvent peaks, which appeared at retention times less than 1.5 min) from the synthetic and recombinant glucagon lots. It was found that the number of impurities observed in the synthetic glucagon were lower than the referenced recombinant glucagon across all stability conditions. Throughout all tested conditions, the synthetic glucagon for injection had an averaged purity of 92.8–99.3%, while the referenced recombinant drug had an averaged purity of 70.3–91.7%. Based on the study results, it can be concluded that the impurity profile for the synthetic glucagon for injection has a comparable and even lower level of impurities than the recombinant version under all stability conditions. |
| first_indexed | 2024-03-09T22:33:41Z |
| format | Article |
| id | doaj.art-3ee7dcd6eb55469f92ed8151eba182ac |
| institution | Directory Open Access Journal |
| issn | 0036-8709 2218-0532 |
| language | English |
| last_indexed | 2024-03-09T22:33:41Z |
| publishDate | 2022-05-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Scientia Pharmaceutica |
| spelling | doaj.art-3ee7dcd6eb55469f92ed8151eba182ac2023-11-23T18:51:11ZengMDPI AGScientia Pharmaceutica0036-87092218-05322022-05-019023210.3390/scipharm90020032Comparison of the Purity and Impurity of Glucagon-for-Injection Products under Various Stability ConditionsZhongli Bao0Ya-Chi Cheng1Mary Ziping Luo2Jack Yongfeng Zhang3Amphastar Pharmaceuticals, Inc., 11570 6th Street, Rancho Cucamonga, CA 91730, USAAmphastar Pharmaceuticals, Inc., 11570 6th Street, Rancho Cucamonga, CA 91730, USAAmphastar Pharmaceuticals, Inc., 11570 6th Street, Rancho Cucamonga, CA 91730, USAAmphastar Pharmaceuticals, Inc., 11570 6th Street, Rancho Cucamonga, CA 91730, USAGlucagon is a polypeptide hormone that serves as an essential therapeutic agent in the emergency treatment of hypoglycemia. Recently, the first generic glucagon for injection was approved. However, unlike its brand name counterpart, which is produced via recombinant DNA, the generic glucagon is produced using a chemical synthesis method. Regardless of its origin, impurities may occur in both glucagon drug products. While these impurities may greatly compromise the safety and efficacy of the glucagon drug products, studies accessing the impurities of glucagon for injection are limited. This manuscript analyzed the stability and impurities of a generic and brand glucagon for injection, including desamido and non-desamido impurities, under various storage and temperature conditions using an ultra-performance liquid chromatography method. The glucagon products were analyzed after 6 and 24 months of storage under room temperatures (20–25 °C). In addition, the products were also assessed after 6 months of storage under high temperatures (40 °C). Under each stability storage condition, three lots of the synthetic glucagon were evaluated by UPLC with at least one lot of the recombinant glucagon for comparison. A total of 37 peaks were identified (except for the solvent peaks, which appeared at retention times less than 1.5 min) from the synthetic and recombinant glucagon lots. It was found that the number of impurities observed in the synthetic glucagon were lower than the referenced recombinant glucagon across all stability conditions. Throughout all tested conditions, the synthetic glucagon for injection had an averaged purity of 92.8–99.3%, while the referenced recombinant drug had an averaged purity of 70.3–91.7%. Based on the study results, it can be concluded that the impurity profile for the synthetic glucagon for injection has a comparable and even lower level of impurities than the recombinant version under all stability conditions.https://www.mdpi.com/2218-0532/90/2/32glucagonHPLCimpuritystabilitysynthetic peptiderecombinant |
| spellingShingle | Zhongli Bao Ya-Chi Cheng Mary Ziping Luo Jack Yongfeng Zhang Comparison of the Purity and Impurity of Glucagon-for-Injection Products under Various Stability Conditions Scientia Pharmaceutica glucagon HPLC impurity stability synthetic peptide recombinant |
| title | Comparison of the Purity and Impurity of Glucagon-for-Injection Products under Various Stability Conditions |
| title_full | Comparison of the Purity and Impurity of Glucagon-for-Injection Products under Various Stability Conditions |
| title_fullStr | Comparison of the Purity and Impurity of Glucagon-for-Injection Products under Various Stability Conditions |
| title_full_unstemmed | Comparison of the Purity and Impurity of Glucagon-for-Injection Products under Various Stability Conditions |
| title_short | Comparison of the Purity and Impurity of Glucagon-for-Injection Products under Various Stability Conditions |
| title_sort | comparison of the purity and impurity of glucagon for injection products under various stability conditions |
| topic | glucagon HPLC impurity stability synthetic peptide recombinant |
| url | https://www.mdpi.com/2218-0532/90/2/32 |
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