General Information

Progesterone Impurities and Progesterone

Daicel Pharma offers high-quality Progesterone impurity standards, 17α-Methyl-17-Keto-D-Homo medroxyprogesterone, 17α-Methyl-17-Keto-D-Homo medroxyprogesterone, 6-Dehydroprogesterone, Progesterone Impurity C, and Progesterone impurity D and E, which is crucial in the analysis of the quality, stability, and biological safety of the active pharmaceutical ingredient Progesterone. Moreover, Daicel Pharma offers custom synthesis of Progesterone impurities and delivers them globally.

Therapeutic Progesterone [CAS: 57-83-0], a synthetic version of the hormone progesterone, prevents ovulation and fertilization in various contraceptive preparations. Additionally, Progesterone induces changes in the endometrium, decreases uterine contractility during pregnancy, and supports the maintenance of pregnancy.

Progesterone: Use and Commercial Availability 

Progesterone is available in various forms, including gelatinized capsules, vaginal gel, vaginal inserts, injections, and contraception tablets. Gelatinized capsules prevent endometrial hyperplasia and treat secondary amenorrhea. Vaginal gel, available in different concentrations, is used in assisted reproductive treatments and for secondary amenorrhea. Vaginal inserts support embryo implantation and early pregnancy. Injections are for amenorrhea and abnormal uterine bleeding, and progesterone tablets act as contraceptives. Some brand names for Progesterone include Crinone, Endometrin, Milprosa, Progestasert, etc.

Progesterone Structure and Mechanism of Action

The chemical name of Progesterone is Pregn-4-ene-3,20-dione. Its chemical formula is C₂₁H₃₀O₂, and its molecular weight is approximately 314.5 g/mol.

Progesterone binds to progesterone receptors, leading to the activation of transcription through interactions with transcription factors. It exerts inhibition on estrogens by reducing estrogen receptors and increasing estrogen metabolism.

Progesterone Impurities and Synthesis

Impurities can form during the synthesis¹, purification, and storage of Progesterone. They can arise from various sources, such as starting materials, reaction intermediates, and degradation products. Controlling the impurity profile of Progesterone is crucial for ensuring its safety and efficacy.

Daicel Pharma offers a Certificate of Analysis (CoA) from a cGMP-compliant analytical facility for Progesterone impurity standards such as 17α-Methyl-17-Keto-D-Homo medroxyprogesterone, 17α-Methyl-17-Keto-D-Homo medroxyprogesterone, 6-Dehydroprogesterone, Progesterone Impurity C, and Progesterone impurity D and E. The CoA includes complete characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity². We also provide 13C-DEPT. Upon delivery, we give a complete characterization report. Daicel Pharma has the technology and expertise to prepare any unknown Progesterone impurity or degradation product.