Description

Hydrocortisone Impurity 16 CAS NO 61774-28-5 is a specified impurity of the corticosteroid Hydrocortisone, used as a critical reference standard in pharmaceutical development and quality control. This compound is essential for ensuring the purity, safety, and efficacy of Hydrocortisone-based drug products by enabling accurate identification and quantification of this specific impurity. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the research, production, and batch release of steroid APIs and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Hydrocortisone Impurity 16 in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development and Validation: Used in the development, optimization, and validation of analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing in pharmaceutical manufacturing to monitor impurity profiles and ensure compliance with pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed as an analytical marker in forced degradation and long-term stability studies to track impurity formation over time and under various stress conditions.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate thorough impurity characterization and control strategies to agencies like the FDA and EMA.
• Research & Development: Used in synthetic chemistry and process development to understand and minimize the formation of this impurity during the manufacturing of Hydrocortisone.

Basic Information

Product Name	Hydrocortisone Impurity 16
CAS No.	61774-28-5
Molecular Formula	C21H30O5
Molecular Weight	362.46 g/mol
Synonyms	11β,17α,21-Trihydroxypregn-4-ene-3,20-dione Impurity; Hydrocortisone Related Compound; 11β,17,21-Trihydroxypregn-4-ene-3,20-dione; Cortisol Impurity; (11β)-11,17,21-Trihydroxypregn-4-ene-3,20-dione; Hydrocortisone EP Impurity; Hydrocortisone USP Related Substance; Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11β)-
EINECS	Contact for details

Quality Control

Our Hydrocortisone Impurity 16 is manufactured under strict quality systems suitable for use as a pharmaceutical reference standard. Each batch undergoes comprehensive analytical characterization using techniques including HPLC, NMR, and Mass Spectrometry to confirm identity and purity. We provide a comprehensive Certificate of Analysis (COA) with batch-specific data, ensuring traceability and compliance with ICH Q3A/B guidelines and relevant pharmacopeial expectations.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
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.