Description

Methylprednisolone Acetate Ep Impurity H CAS NO 1968-76-9 is a high-purity reference standard specifically used for analytical and quality control purposes within the pharmaceutical industry. This compound is critical for ensuring the safety and efficacy of Methylprednisolone Acetate, a widely used corticosteroid, by enabling the accurate identification and quantification of this specific impurity during drug development and manufacturing. It is an essential material for analytical chemists, quality assurance laboratories, and regulatory affairs professionals working on steroid-based pharmaceuticals.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for calibrating analytical instruments and validating testing methods.
• Impurity Profiling & Identification: Used in HPLC, LC-MS, and GC-MS analyses to identify and quantify Methylprednisolone Acetate Ep Impurity H in active pharmaceutical ingredients (APIs) and finished drug products.
• Method Development & Validation: A critical component in developing and validating stability-indicating assay methods for Methylprednisolone Acetate according to ICH guidelines.
• Quality Control & Batch Release: Employed in routine QC testing to ensure drug substance and product batches comply with stringent pharmacopeial limits for specified impurities.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of impurity characterization and control strategies.
• Stability Studies: Used to monitor the formation of this impurity over time under various stress conditions (heat, light, humidity) to establish product shelf life.

Basic Information

Product Name	Methylprednisolone Acetate Ep Impurity H
CAS No.	1968-76-9
Molecular Formula	C24H32O6
Molecular Weight	416.51 g/mol
Synonyms	6α-Methylprednisolone 17-Acetate; 11β,17α,21-Trihydroxy-6α-methylpregna-1,4-diene-3,20-dione 21-Acetate; 6α-Methylprednisolone 21-Acetate; Methylprednisolone 21-Acetate Impurity H; EP Impurity H of Methylprednisolone Acetate; δ-1-Cortienic Acid Methyl Ester Acetate (related); 6-Methylprednisolone Acetate Isomer
EINECS	Contact for details

Quality Control

Our Methylprednisolone Acetate Ep Impurity H is manufactured under strict quality systems to ensure it meets the exacting requirements for a pharmaceutical reference standard. Each batch is subjected to comprehensive analytical testing, including orthogonal methods for identity confirmation and high-precision assay. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting purity, chromatographic profile, and results from tests such as HPLC, NMR, and mass spectrometry to support your regulatory and QC needs.

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 material is hygroscopic (moisture-sensitive) and light-sensitive; ensure the container is sealed after each use to minimize exposure to atmospheric moisture and light.

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% w/w
Residue on Ignition	≤ 0.1%

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