Description

Ascomycin Impurity 1 CAS NO 148147-41-5 is a high-purity chemical reference standard, specifically identified as a process-related impurity of the macrolide immunosuppressant Ascomycin. This compound is critical for analytical method development, validation, and quality control in pharmaceutical research and manufacturing. It is primarily utilized by researchers and quality assurance professionals in the pharmaceutical and biotechnology industries to ensure the purity, safety, and efficacy of active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of Ascomycin-related impurities.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods.
• Quality Control (QC) & Quality Assurance (QA): Essential for routine batch testing and stability studies to monitor impurity levels in drug substances and products.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs).
• Research & Development: Used in metabolic and pharmacokinetic studies to understand the degradation pathways of Ascomycin.
• Calibration Standard: Acts as a primary standard for calibrating analytical instruments in quality control laboratories.

Basic Information

Product Name	Ascomycin Impurity 1
CAS No.	148147-41-5
Molecular Formula	C44H69NO12
Molecular Weight	804.0 g/mol
Synonyms	FR-900520 Impurity 1; Pimecrolimus Impurity 1; (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-1,14-Dihydroxy-12-[(1E)-2-[(1R,3R,4S)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-23,25-dimethoxy-13,19,21,27-tetramethyl-17-(2-propen-1-yl)-11,28-dioxa-4-azatricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetrone; 33-Epi-Chloro-33-desoxyascomycin; Ascomycin Related Compound A
EINECS	Contact for details

Quality Control

Every batch of Ascomycin Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to support your regulatory and research requirements.

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 maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Single Unknown Impurity (HPLC)	≤ 1.0%
Total Impurities (HPLC)	≤ 5.0%

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