Product Information
Product Code: E059007
English Name: Estradiol Valerate EP Impurity C
English Alias: (8R,9S,13S,14S,17S)-13-methyl-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,17-diyl dipentanoate
CAS Number: 63042-28-4
Molecular Formula: C28H40O4
Molecular Weight: 440.61
Advantages: As a reference standard for Estradiol Valerate EP Impurity C, its structure is confirmed by multiple techniques including NMR and HRMS, with a purity of ≥99.0% (HPLC). It exhibits good stability under sealed storage at 2 - 8℃ in the dark, with a shelf life of 36 months and batch-to-batch variation <0.3%. Its high purity and stability ensure the accuracy and repeatability of impurity analysis, meeting strict requirements for pharmaceutical quality control and methodology validation.
Applications:
Quality Testing: Used for the detection of Impurity C in Estradiol Valerate API and formulations by HPLC and LC - MS, controlling impurity content according to EP, ICH, and other standards to ensure drug quality compliance.
Process Optimization: Monitor the content of Impurity C in real-time during Estradiol Valerate synthesis. Optimize the process by adjusting parameters such as esterification reaction temperature, time, and catalyst type to reduce impurity generation.
Stability Studies: Track the changes in Impurity C content during accelerated stability tests (e.g., 60℃/RH75%) and long-term stability tests, evaluate its impact on drug stability, and provide data for determining shelf life and storage conditions.
Regulatory Compliance: Assist pharmaceutical companies in meeting the requirements of regulatory agencies such as FDA, EMA, and NMPA for drug impurity limits, providing accurate impurity detection data during drug registration and application.
Background Description: Estradiol Valerate is an estrogen drug commonly used in hormone replacement therapy, contraception, and other fields. During its synthesis and formulation, various impurities may be generated due to impure raw materials, reaction conditions, or side reactions. As a specific impurity of Estradiol Valerate, the presence of Impurity C may affect drug activity and even endanger patient health. With the increasingly strict global regulatory requirements for impurity control, the research and control of Estradiol Valerate EP Impurity C have become crucial for ensuring drug quality and safety.
Research Status:
Detection Technology: UPLC - MS/MS is employed with a C18 column (1.7μm, 2.1×100mm) and a gradient elution of 0.1% formic acid water - acetonitrile, enabling the separation of Impurity C within 3 minutes with a detection limit of 0.005 ng/mL, significantly improving sensitivity compared to traditional HPLC.
Formation Mechanism: Research indicates that Impurity C may result from excessive esterification of the 3,17-hydroxyl groups during Estradiol Valerate synthesis or the participation of similar-structured impurities in the reaction. Optimizing the ratio of esterification reagents and shortening the reaction time can reduce the content of Impurity C by over 80%.
Safety Evaluation: Preliminary toxicological studies show that high concentrations of Impurity C may interfere with the human estrogen receptor signaling pathway. Currently, the limit for this impurity in drug quality standards is set at ≤0.1%. Further research using animal experiments and cell models is needed to explore its toxic mechanism and improve the risk assessment system.
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E-mail: anna@molcoo.com
NOTE！
We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.
This product is intended for laboratory use only!
WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com
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