Description

11,17,21-Trihydroxy-Pregn-5-Ene-3,20-Dione-D4 3,20-Diethylene Ketal is a deuterium-labeled derivative of a pregnane steroid, specifically designed as a high-purity reference standard. This compound is critical for ensuring analytical accuracy and method validation in sophisticated research and quality control environments. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical testing facilities specializing in steroid analysis, metabolism studies, and bioanalytical method development.

Application

• Internal Standard for LC-MS/MS: Serves as a stable, isotopically labeled internal standard for the precise quantification of related steroid hormones and metabolites in complex biological matrices like plasma, serum, and urine.
• Pharmaceutical Impurity Profiling: Used as a reference material to identify, characterize, and quantify process-related impurities and degradation products in steroid-based active pharmaceutical ingredients (APIs).
• Metabolic Pathway Research: Enables the tracing and study of steroid biotransformation and metabolic pathways in preclinical and clinical research settings.
• Method Development & Validation: Essential for developing, optimizing, and validating highly sensitive and specific analytical methods (HPLC, UPLC, GC-MS) in compliance with ICH guidelines.
• Quality Control & Assurance: Provides a certified reference point for in-house quality control testing to ensure the identity, purity, and potency of steroid products.
• Forensic & Doping Control Analysis: Applied in specialized testing laboratories for the accurate detection and confirmation of exogenous steroids and their metabolites.

Basic Information

Item	Details
Product Name	11,17,21-Trihydroxy-Pregn-5-Ene-3,20-Dione-D4 3,20-Diethylene Ketal
CAS No.	134354-11-3
Molecular Formula	C25H34D4O6
Molecular Weight	Contact for details
Synonyms	11β,17α,21-Trihydroxypregn-4-ene-3,20-dione-19,19,21,21-d4 3,20-bis(ethylenedioxy); Deuterated Prednisolone 3,20-Diethyl Ketal; [19,19,21,21-d4]-11β,17α,21-Trihydroxypregn-4-ene-3,20-dione 3,20-bis(ethylenedioxy); Prednisolone-d4 3,20-Diethylene Ketal; 11β,17α,21-Trihydroxy-1,4-pregnadiene-3,20-dione-d4 3,20-Diethyl Ketal; Cortisol-d4 Derivative; Deuterium Labeled Steroid Ketal.
EINECS	Contact for details

Quality Control

Every batch of 11,17,21-Trihydroxy-Pregn-5-Ene-3,20-Dione-D4 3,20-Diethylene Ketal is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with the high-purity standards required for reference materials. A comprehensive Certificate of Analysis (COA) detailing identity, purity (HPLC), isotopic enrichment, and specific tests is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Isotopic Purity (d4)	≥ 98.0 atom % D
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.