Description

Prednicarbate Related Compound A (20 Mg) (1,2-Dihydroprednicarbate) is a high-purity chemical reference standard, essential for analytical research and quality control in pharmaceutical development. This compound serves as a critical impurity marker for the topical corticosteroid Prednicarbate, enabling precise identification and quantification during method validation and stability studies. It is primarily required by analytical chemists, quality assurance laboratories, and research institutions focused on steroid API manufacturing and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of 1,2-Dihydroprednicarbate in Prednicarbate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: A critical component for developing and validating HPLC, UPLC, or GC methods to ensure specificity, accuracy, and robustness in testing protocols.
• Stability-Indicating Studies: Employed to monitor the formation of this related compound during forced degradation and long-term stability studies of Prednicarbate formulations.
• Quality Control (QC) Testing: Serves as a system suitability standard and a calibrant in routine QC laboratories to ensure batch-to-batch consistency and purity of the main drug substance.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing characterized impurity standards necessary for setting specifications and justifying limits.
• Research & Development: Utilized in metabolic and pharmacokinetic studies to understand the degradation pathways of Prednicarbate.

Basic Information

Product Name	Prednicarbate Related Compound A (20 Mg) (1,2-Dihydroprednicarbate)
CAS No.	671225-26-6
Molecular Formula	C₂₇H₃₆O₈
Molecular Weight	488.57 g/mol
Synonyms	1,2-Dihydroprednicarbate; Prednicarbate Impurity A; Prednicarbate Related Substance A; 17-[(Ethoxycarbonyl)oxy]-11β,21-dihydroxy-1,4-pregnadiene-3,20-dione; 11β,17,21-Trihydroxy-1,4-pregnadiene-3,20-dione 17-ethyl carbonate; Prednicarbate EP Impurity A; Prednicarbate USP Related Compound A
EINECS	Contact for details

Quality Control

Every batch of Prednicarbate Related Compound A is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including HPLC purity assay, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for reference materials. A detailed Certificate of Analysis (COA) is provided with each unit, documenting the exact purity, batch number, and analytical results. Our quality commitment aligns with the expectations of pharmaceutical R&D and QC laboratories globally.

Storage

Preserve in the original 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); ensure the container is kept tightly sealed in a low-humidity environment to maintain stability and purity. For long-term storage, consider desiccants.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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