Description

Budesonide Impurity (1, 4-Androstadien-11-β-16-Alfa-Diol-3, 17-Dione) is a high-purity reference standard critical for pharmaceutical research and development. This compound serves as a key impurity in the synthesis and quality control of Budesonide, a widely used corticosteroid. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable standards for method validation, stability studies, and regulatory compliance. Ensuring the integrity of your analytical data starts with sourcing impurities of definitive identity and purity.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Budesonide Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and GC methods to ensure specificity, accuracy, and robustness in impurity profiling.
• Stability Studies: Employed to monitor the formation of degradation products in Budesonide formulations under various stress conditions (e.g., heat, light, humidity).
• Quality Control & Assurance (QC/QA): A vital tool for in-process control and release testing of Budesonide batches to meet pharmacopeial standards (USP, EP, ICH).
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs).
• Research & Development: Used in synthetic chemistry research to study metabolic pathways and the synthesis of steroid analogs.

Basic Information

Product Name	Budesonide Impurity (1, 4-Androstadien-11-β-16-Alfa-Diol-3, 17-Dione)
CAS No.	910299-74-0
Molecular Formula	C19H24O4
Molecular Weight	316.39 g/mol
Synonyms	1,4-Androstadiene-11β,16α-diol-3,17-dione; 11β,16α-Dihydroxy-1,4-androstadiene-3,17-dione; Budesonide Impurity A (according to some sources); Budesonide Related Compound A; 16α-Hydroxyprednisolone Impurity; Steroid Impurity Standard
EINECS	Contact for details

Quality Control

Every batch of our Budesonide Impurity standard is manufactured and analyzed under strict quality systems. We provide comprehensive analytical data to support its use in GMP environments, including full characterization by NMR, MS, and HPLC. Our quality commitment ensures compliance with ICH Q3A/B guidelines for impurities. A detailed Certificate of Analysis (COA) is supplied with each lot, confirming identity, purity (typically ≥95% by HPLC), and impurity profile.

Storage

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

Specification

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

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