Description

Cortisol Impurity CAS NO 70795-33-4 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the accuracy and reliability of analytical methods in pharmaceutical development and quality control. It is primarily utilized by researchers and quality assurance professionals in the pharmaceutical, biotechnology, and contract research organization (CRO) sectors for method validation, impurity profiling, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of related substances in Cortisol (Hydrocortisone) Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation (HPLC/LC-MS): Used as a critical system suitability standard to develop, optimize, and validate chromatographic methods for purity analysis.
• Quality Control (QC) Testing: Employed in-house by pharmaceutical manufacturers as a primary standard for routine batch release testing to ensure product safety and efficacy.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and ICH guidelines.
• Stability Studies: Used to monitor the formation of degradation products in Cortisol-based formulations under various stress conditions.
• Academic and Clinical Research: Supports metabolic studies and biochemical research involving corticosteroid pathways and related impurities.

Basic Information

Product Name	Cortisol Impurity
CAS No.	70795-33-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cortisol Related Compound; Hydrocortisone Impurity; 11β,17α,21-Trihydroxypregn-4-ene-3,20-dione Impurity; (11β)-11,17,21-Trihydroxypregn-4-ene-3,20-dione Impurity; Steroid Impurity; Corticosteroid Impurity Standard; Cortisol EP Impurity; Cortisol USP Related Substance
EINECS	Contact for details

Quality Control

Our Cortisol Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) with each shipment, detailing batch-specific results. Our quality standards are designed to support compliance with ICH Q3A/B, USP, and EP guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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