Description

Budesonide Impurity 7 is a specified impurity and degradation product of the active pharmaceutical ingredient Budesonide, a potent glucocorticoid steroid. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control processes. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Budesonide-based drug products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Budesonide API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and GC methods to monitor impurity profiles during stability studies.
• Quality Control & Assurance: Employed in routine QC testing to ensure batch-to-batch consistency and compliance with ICH Q3A/B guidelines on impurities.
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., for FDA, EMA) to establish impurity limits and justify specifications.
• Stability Studies: Used to track the formation of degradation products under various stress conditions (light, heat, humidity).
• Process Chemistry Research: Aids in understanding the synthesis pathway and optimizing manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Budesonide Impurity 7
CAS No.	3949-79-9
Molecular Formula	C25H34O6
Molecular Weight	430.53 g/mol
Synonyms	16α-Hydroxyprednisolone; 11β,16α,17,21-Tetrahydroxypregna-1,4-diene-3,20-dione; 16α-Hydroxy Prednisolone; 16α-Hydroxycortisone; 16α-Hydroxy-11β,17α,21-trihydroxypregna-1,4-diene-3,20-dione; Budesonide Related Compound; Prednisolone 16α-ol
EINECS	Contact for details

Quality Control

Our Budesonide Impurity 7 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with ICH and pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under inert atmosphere to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
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.