Description

16α-Butyloxyprednisolone (Budenoside Impurity) is a high-purity chemical reference standard used for analytical and research purposes. This compound is critically important for pharmaceutical quality control, specifically in the development and validation of analytical methods for the corticosteroid Budesonide. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories to ensure product purity, meet regulatory compliance, and support impurity profiling studies.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of related substances in Budesonide Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating high-performance liquid chromatography (HPLC) and other chromatographic methods in QC laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive impurity characterization data required for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to monitor the formation of degradation products in Budesonide formulations under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Used in synthetic chemistry research to study metabolic pathways, degradation mechanisms, and to synthesize related steroid analogs.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability standard and for routine batch release testing to ensure API and drug product specifications are met.

Basic Information

Product Name	16α-Butyloxyprednisolone (Budenoside Impurity)
CAS No.	113930-13-5
Molecular Formula	C29H42O7
Molecular Weight	502.64 g/mol
Synonyms	16α-Butyloxyprednisolone; 11β,21-Dihydroxy-16α-(butyloxy)-1,4-pregnadiene-3,20-dione; Budesonide Impurity; Budesonide Related Compound; 16α-n-Butoxyprednisolone; Prednisolone 16α-butyl ether; (11β,16α)-11,21-Dihydroxy-16-(butoxy)-1,4-pregnadiene-3,20-dione
EINECS	Contact for details

Quality Control

Every batch of 16α-Butyloxyprednisolone is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and accurate identification, meeting the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) detailing purity, impurities, and analytical methods are provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
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%
Residue on Ignition	≤ 0.1%

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