Description

Hydrocortisone Impurity I CAS NO 103795-84-2 is a specified impurity and reference standard used in the quality control of Hydrocortisone, a critical corticosteroid API. This compound is essential for pharmaceutical manufacturers and analytical laboratories to ensure product purity, safety, and regulatory compliance. It is primarily used in research and development, method validation, and as a critical benchmark in the quality assurance of steroid-based drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Hydrocortisone Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and GC methods to establish system suitability, specificity, and detection limits for impurity profiling.
• Quality Control & Assurance (QC/QA): Critical for routine batch testing to monitor impurity levels and ensure compliance with pharmacopeial monographs (USP, EP, BP, JP).
• Stability Studies: Employed to track the formation of degradation products in Hydrocortisone formulations under various stress conditions.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research on Steroid Metabolism & Synthesis: Used as an intermediate or marker in studies investigating the synthesis pathways or metabolic breakdown of corticosteroids.

Basic Information

Item	Detail
Product Name	Hydrocortisone Impurity I
CAS No.	103795-84-2
Molecular Formula	C21H30O5
Molecular Weight	362.46 g/mol
Synonyms	11β,17α,21-Trihydroxypregn-4-ene-3,20-dione Impurity I; 11β-Hydroxyandrost-4-ene-3,17-dione 17-(1-hydroxyethyl) side chain derivative; Hydrocortisone Related Compound I; Cortisol Impurity I; 17α,21-Dihydroxypregn-4-ene-3,11,20-trione (possible structural synonym); Hydrocortisone EP Impurity I; Hydrocortisone USP Related Substance I
EINECS	Contact for details

Quality Control

Every batch of Hydrocortisone Impurity I is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including identity confirmation by spectroscopic methods (IR, NMR) and purity determination by advanced chromatographic techniques (HPLC). Certificates of Analysis (COA) detailing batch-specific results are available upon request, supporting your regulatory and quality documentation needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is light-sensitive (store away from light). For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 1.0% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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