Description

Hydrocortisone Impurity 6 is a specified impurity of the corticosteroid Hydrocortisone, identified by the CAS registry number 136370-31-5. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical profiling and quality control of Hydrocortisone active pharmaceutical ingredients (APIs) and finished drug products. It is an essential material for scientists and quality assurance professionals in the pharmaceutical industry who are engaged in method development, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Hydrocortisone Impurity 6 in Hydrocortisone drug substances and products.
• Analytical Method Development and Validation: Crucial for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to monitor impurities in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Indicating Studies: Used to assess the degradation pathways of Hydrocortisone under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Quality Control and Batch Release: Employed in routine QC testing to ensure Hydrocortisone APIs and formulations meet stringent purity specifications and regulatory standards (USP, EP, JP).
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing necessary impurity characterization data and specifications.
• Research into Degradation Chemistry: Facilitates research aimed at understanding the formation mechanisms and chemical behavior of this specific impurity.

Basic Information

Item	Detail
Product Name	Hydrocortisone Impurity 6
CAS No.	136370-31-5
Molecular Formula	C21H30O5
Molecular Weight	362.46 g/mol
Synonyms	11β,17α,21-Trihydroxypregn-4-ene-3,20-dione Impurity 6; Cortisol Impurity 6; 17-Hydroxycorticosterone Impurity 6; (11β)-11,17,21-Trihydroxypregn-4-ene-3,20-dione related compound; Hydrocortisone Related Compound 6; Hydrocortisone EP Impurity 6; Hydrocortisone USP Related Substance 6
EINECS	Contact for details

Quality Control

Our Hydrocortisone Impurity 6 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided for every lot, supporting compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

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

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