Description

Prednicarbate Related Compound C (20 Mg) (Prednisolone-21-Propionate) CAS NO 5740-62-5 is a high-purity reference standard, specifically the 21-propionate ester of prednisolone, used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products, particularly in the development and quality control of corticosteroid APIs and formulations. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in method validation, impurity profiling, and compliance testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Prednicarbate drug substance and finished products.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, and GC methods to ensure specificity, accuracy, and precision in assay and impurity tests.
• Quality Control & Assurance (QC/QA): Used in routine batch testing within pharmaceutical QC laboratories to monitor process-related impurities and ensure product meets pharmacopeial specifications (e.g., USP, EP).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive impurity characterization data for health authorities like the FDA and EMA.
• Stability Studies: Employed to identify and track degradation products in forced degradation and long-term stability studies of corticosteroid formulations.
• Research & Development: Serves as a key intermediate or impurity marker in synthetic chemistry R&D for novel corticosteroid analogs and process optimization.

Basic Information

Product Name	Prednicarbate Related Compound C (20 Mg) (Prednisolone-21-Propionate)
CAS No.	5740-62-5
Molecular Formula	C24H32O6
Molecular Weight	416.51 g/mol
Synonyms	Prednisolone 21-Propionate; 11β,17α,21-Trihydroxypregna-1,4-diene-3,20-dione 21-Propionate; Prednicarbate Impurity C; Prednisolone 21-Propanoate; Delta1-Cortisol 21-Propionate; NSC 106977; 1,4-Pregnadiene-11β,17α,21-triol-3,20-dione 21-propionate
EINECS	Contact for details

Quality Control

Every batch of Prednicarbate Related Compound C is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, NMR, and mass spectrometry to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each unit, detailing batch-specific results, and is available upon request to support your regulatory and quality documentation needs.

Storage

Preserve in the original, tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C to 25°C (59°F to 77°F). Keep the container in a dry, cool place away from sources of heat and moisture. Do not freeze.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.