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Evaluation of temperature, excipients impact on the primary structure of Ganirelix in an injectable formulation, and comparison with Orgalutran® using MALDI-TOF/TOF-MS.
Journal of Mass Spectrometry ( IF 2.3 ) Pub Date : 2020-07-03 , DOI: 10.1002/jms.4610 Kumarswamy Ummiti 1 , J V Shanmukha Kumar 1
Journal of Mass Spectrometry ( IF 2.3 ) Pub Date : 2020-07-03 , DOI: 10.1002/jms.4610 Kumarswamy Ummiti 1 , J V Shanmukha Kumar 1
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Ganirelix is a linear polypeptide consisting of covalently bonded 10 amino acid residues. The amino acid sequence in a peptide determines the properties of the molecule. The slightest change in the primary structure (amino acid sequence) of therapeutic peptides can significantly impact its safety, efficacy, and immunogenicity. Hence, the primary structure analysis of therapeutic peptides is regarded as a critical quality attribute (CQA). A vast array of analytical techniques can be used to capture the primary structure of the peptide. In this study, we applied matrix‐assisted laser desorption ionization (MALDI)/tandem time of flight mass spectroscopic (TOF/TOF MS) method to demonstrate the primary structure of Ganirelix in an injectable formulation. The apparent monoisotopic molecular mass of Ganirelix is 1,568.9 Da. The attained primary amino acid sequence of Ganirelix in temperature‐stressed generic product matched with the theoretical sequence and showed homology with those of the reference listed drug (RLD).
中文翻译:
评估温度,赋形剂对注射剂中Ganirelix一级结构的影响,并使用MALDI-TOF / TOF-MS与Orgalutran®进行比较。
Ganirelix是由共价键合的10个氨基酸残基组成的线性多肽。肽中的氨基酸序列决定了分子的特性。治疗性肽的一级结构(氨基酸序列)中的最细微变化都可能显着影响其安全性,功效和免疫原性。因此,治疗性肽的一级结构分析被认为是关键的质量属性(CQA)。大量分析技术可用于捕获肽的一级结构。在这项研究中,我们应用基质辅助激光解吸电离(MALDI)/串联飞行时间质谱(TOF / TOF MS)方法来证明可注射制剂中Ganirelix的主要结构。Ganirelix的表观单同位素分子量为1,568.9 Da。
更新日期:2020-08-14
中文翻译:
评估温度,赋形剂对注射剂中Ganirelix一级结构的影响,并使用MALDI-TOF / TOF-MS与Orgalutran®进行比较。
Ganirelix是由共价键合的10个氨基酸残基组成的线性多肽。肽中的氨基酸序列决定了分子的特性。治疗性肽的一级结构(氨基酸序列)中的最细微变化都可能显着影响其安全性,功效和免疫原性。因此,治疗性肽的一级结构分析被认为是关键的质量属性(CQA)。大量分析技术可用于捕获肽的一级结构。在这项研究中,我们应用基质辅助激光解吸电离(MALDI)/串联飞行时间质谱(TOF / TOF MS)方法来证明可注射制剂中Ganirelix的主要结构。Ganirelix的表观单同位素分子量为1,568.9 Da。