Description

Gamithromycin Impurity CAS NO 1797448-01-1 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the veterinary antibiotic Gamithromycin. It is primarily utilized by pharmaceutical R&D laboratories, quality control (QC) departments, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) to identify, quantify, and monitor this specific impurity in Gamithromycin active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating chromatographic methods, such as HPLC and UPLC, to ensure accurate detection and quantification limits.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing within pharmaceutical manufacturing to confirm impurity levels are within specified limits per ICH guidelines.
• Regulatory Compliance & Submissions: Essential for preparing documentation for regulatory filings (e.g., FDA, EMA) to demonstrate thorough understanding and control of the drug substance's impurity profile.
• Stability Studies: Used as a marker to track the formation or increase of this impurity over time under various storage conditions, supporting shelf-life determination.
• Research & Development: Facilitates chemical and metabolic studies to understand the degradation pathways and formation mechanisms of Gamithromycin-related impurities.

Basic Information

Product Name	Gamithromycin Impurity
CAS No.	1797448-01-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Gamithromycin Related Compound; Gamithromycin Specified Impurity; Gamithromycin Degradant; 1797448-01-1; (3R,4S,5S,6R,7R,9R,11R,12R,13S,14R)-4-[(2,6-Dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-12,13-dihydroxy-7-methoxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione Impurity
EINECS	Contact for details

Quality Control

Our Gamithromycin Impurity is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and stability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications aligned with ICH Q3A/B guidelines. We support GMP-grade production for regulatory applications upon request.

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 must be kept under inert conditions or in a desiccator to maintain stability and purity. Avoid repeated or prolonged exposure to the atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches CRM
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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