Product Description
(2b,3a,5a,16b,17b)-2-(4-Morpholinyl)-16-(1-pyrrolidinyl)androstane-3,17-diol, also commonly known as Rocuronium Impurity C, is a significant related compound and known impurity of Rocuronium Bromide, an aminosteroidal non-depolarizing neuromuscular blocking agent. This compound is crucial in the pharmaceutical industry for quality control and analytical purposes related to Rocuronium Bromide synthesis and formulation. Its presence and quantification are important for ensuring the safety and efficacy of the final drug product.
Product Properties
Property Description Chemical Formula C28H48N2O3 Molecular Weight 460.69 g/mol Appearance Typically a white to off-white solid or crystalline powder Synonyms Rocuronium Impurity C, Rocuronium Bromide EP Impurity C (and other pharmacopoeial impurity designations) Primary Role Pharmaceutical impurity, analytical reference standard Solubility Generally soluble in organic solvents like methanol, acetonitrile; sparingly soluble in water Product Usage
(2b,3a,5a,16b,17b)-2-(4-Morpholinyl)-16-(1-pyrrolidinyl)androstane-3,17-diol is primarily utilized in pharmaceutical contexts:
- Pharmaceutical Reference Standard: It serves as a characterized reference material for the identification and quantification of this specific impurity in batches of Rocuronium Bromide active pharmaceutical ingredient (API) and finished drug products.
- Quality Control (QC): Used in QC laboratories to perform purity tests and ensure that the levels of this impurity in Rocuronium Bromide are within compendial limits and regulatory specifications.
- Analytical Method Development & Validation: Employed during the development, validation, and transfer of analytical methods (e.g., HPLC) designed to detect and measure impurities in Rocuronium Bromide.
- Stability Studies: Can be used in stability studies of Rocuronium Bromide to understand degradation pathways that might lead to the formation of this impurity.
- Pharmacopoeial Compliance: Essential for manufacturers of Rocuronium Bromide to comply with pharmacopoeial monographs that specify limits for related substances.
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