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: C??H??O?

Molecular Weight: 440.61

Advantages

High Purity and Precise Structure: The structure is confirmed by multiple techniques such as NMR and MS, with a purity of ≥98.5% (HPLC), ensuring the accuracy of impurity qualitative and quantitative analysis.

Stable and Reliable: Under the conditions of 2 - 8℃ in a dark and dry environment, the shelf life is up to 24 months, with high batch-to-batch quality consistency, meeting the needs of long-term quality control.

Applications

Pharmaceutical Quality Testing: Used for the detection of Impurity C in Estradiol Valerate API and formulations by HPLC and LC-MS, strictly controlling the impurity content to meet European Pharmacopoeia (EP) standards.

Process Optimization: During the synthesis of Estradiol Valerate, monitor the generation of Impurity C. Adjust esterification reaction conditions (such as temperature and catalyst dosage) to reduce impurity content and improve product purity.

Stability Studies: Track the change trend of Impurity C in accelerated stability tests (40℃/RH75%) and long-term stability tests, providing data support for drug storage conditions and shelf life.

Regulatory Compliance: Assist pharmaceutical companies in meeting the requirements of domestic and international drug regulatory agencies (such as EMA, NMPA) for drug impurity limits, ensuring that products meet regulatory standards during registration and application.

Background Description

Research Status

Detection Technology: LC-MS/MS is the mainstream technology. By optimizing the chromatographic column (C18 column, 1.8μm particle size), mobile phase system (acetonitrile - water gradient elution), and mass spectrometry parameters, highly sensitive detection of Impurity C can be achieved, with a detection limit as low as 0.01 ng/mL.

Formation Mechanism: Research shows that Impurity C mainly originates from side reactions in the esterification process of Estradiol Valerate synthesis. Residual raw materials or excessive reactions will promote its generation. Improving reaction conditions and purification processes can effectively inhibit impurity production.

Safety Evaluation: The toxicological research on Impurity C is gradually being carried out. Preliminary experiments show that high concentrations of Impurity C may have potential effects on the endocrine system. Currently, strict limits have been set for it in drug quality standards. Further in-depth research on its toxicity mechanism is needed to improve impurity control strategies.