Description

Hydrocortisone Impurity 20 is a specified impurity of the corticosteroid Hydrocortisone, a critical reference standard for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is essential for ensuring the purity, safety, and efficacy of Hydrocortisone-based drug products by enabling accurate identification and quantification during stability testing and batch release. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and manufacturers of active pharmaceutical ingredients (APIs) who must comply with stringent regulatory guidelines for impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Hydrocortisone Impurity 20 in Hydrocortisone API and finished dosage forms.
• Method Development and Validation: Critical for developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and LC-MS, for impurity profiling.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Quality Control (QC) Testing: Serves as a system suitability standard and for preparing calibration curves in routine QC testing of Hydrocortisone batches.
• Regulatory Compliance and Filing: Provides necessary data for regulatory submissions (e.g., to FDA, EMA) to establish impurity thresholds and justify specifications.
• Research and Development: Used in studies to understand the degradation pathways and chemical behavior of Hydrocortisone.

Basic Information

Item	Detail
Product Name	Hydrocortisone Impurity 20
CAS No.	103242-89-3
Molecular Formula	C21H28O5
Molecular Weight	360.45 g/mol
Synonyms	11β,17α,21-Trihydroxypregn-4-ene-3,20-dione Impurity; Hydrocortisone Related Compound 20; Cortisol Impurity 20; (11β)-11,17,21-Trihydroxypregn-4-ene-3,20-dione; 17-Hydroxycorticosterone Impurity; Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11β)-; Hydrocortisone EP Impurity 20
EINECS	Contact for details

Quality Control

Our Hydrocortisone Impurity 20 is manufactured and handled under strict quality systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity confirmation and structural verification by spectroscopic methods (IR, NMR, MS). A Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request. Our quality commitment aligns with the standards required for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry environment to minimize moisture uptake.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
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.