Glasdegib Impurities and Glasdegib
Daicel Pharma specializes in synthesizing impurities for Glasdegib, an active pharmaceutical ingredient. We offer labeled compounds such as Glasdegib-D4 and Glasdegib-D4- Diastereomer, which play a vital role in evaluating the purity and safety of Glasdegib. Daicel Pharma also provides custom synthesis of Glasdegib impurities to meet specific client needs and offer worldwide delivery options.
Glasdegib [CAS: 1095173-27-5] is an orally available small molecule and an inhibitor of the Hedgehog (Hh) signaling pathway. It is an antineoplastic agent in treating acute myeloid leukemia. Glasdegib can exhibit antineoplastic properties by targeting the Hh signaling pathway.
Glasdegib: Use and Commercial Availability
Daurismo is the brand name under which Glasdegib is available. It treats newly diagnosed acute myeloid leukemia in adult patients over 75 years old or having co-morbidities that prevent them from receiving intensive induction chemotherapy. Acute myeloid leukemia involves abnormal production of myeloblasts, red cells, or platelets.
Glasdegib Structure and Mechanism of Action
The chemical name of Glasdegib is N-[(2R,4R)-2-(1H-Benzimidazol-2-yl)-1-methyl-4-piperidinyl]-N′-(4-cyanophenyl)urea. Its chemical formula is C21H22N6O, and its molecular weight is approximately 374.4 g/mol.
Glasdegib inhibits and binds to Smoothened (SMO), a protein involved in the hedgehog signal transduction.
Glasdegib Impurities and Synthesis
During the synthesis1 of Glasdegib, several impurities form. Common impurities include related compounds or intermediates. They can arise from side reactions, incomplete conversions, or degradation during the manufacturing process. Their presence may impact the purity, stability, and efficacy of Glasdegib. Strict quality control measures require rigorous purification techniques such as chromatography and crystallization to ensure the production of high-quality Glasdegib.
Daicel Pharma, in adherence to cGMP standards, has an analytical facility where we prepare Glasdegib impurities. We offer deuterium-labeled Glasdegib standards such as Glasdegib-D4 and Glasdegib-D4- Diastereomer for bioanalytical research and BA/BE studies, crucial for developing chemical and biological drugs. We provide a comprehensive Certificate of Analysis (CoA) with a detailed characterization report. The CoA includes data obtained through techniques, 1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis2. Upon request, we provide additional data like 13C-DEPT. We can also synthesize unknown Glasdegib impurities or degradation products, and labeled compounds, to assess the effectiveness of generic Glasdegib. Each delivery has a comprehensive characterization report.
- Munchhof, Michael J.; Reiter, Lawrence A.; La Greca, Susan D.; Jones, Christopher S.; Li, Qifang, Benzimidazole derivatives, Pfizer Inc., United States, US8148401B2, April 3, 2012
- Satyanarayana, P.; Bajivali, Sk.; Usharani, M.; Mohan, S., A new way of method establish and validated of related substance of glasdegib by RP-HPLC and its forced degradation study, International Journal of Pharmaceutical Sciences and Research, Volume: 12, Issue: 3, Pages: 1599-1607, 2021
Frequently Asked Questions
Impurities in Glasdegib can contribute to its degradation or instability under specific storage conditions. Therefore, proper storage conditions, including temperature, light exposure, and moisture control, are essential to maintain the stability and quality of the drug over its shelf life.
Yes, impurities in Glasdegib undergo toxicity testing to assess their potentially harmful effects. These tests help determine their safety profile and establish acceptable limits to ensure patient safety.
During commercial production of Glasdegib, strict regulation of impurity levels is done through quality control measures. Batch testing, validation of manufacturing processes, and compliance with regulatory guidelines help ensure consistent quality and safety of the drug.
Methanol is a common solvent used when analyzing many impurities in Glasdegib.
The recommendation is to store Glasdegib impurities at a controlled room temperature, within 2-8 °C.
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