Description

Disaccharides Impurities CAS NO 1093278-53-5 is a high-purity reference standard used for the identification, qualification, and quantification of related substances in disaccharide-based pharmaceutical products and research materials. This compound is critical for ensuring the accuracy and reliability of analytical methods, directly supporting quality control and regulatory compliance. It is primarily utilized by analytical laboratories, quality assurance departments, and research scientists in the pharmaceutical, biotechnology, and fine chemical industries.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material (CRM) for the analysis of impurities in active pharmaceutical ingredients (APIs) and finished drug products containing disaccharide moieties.
• Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods (HPLC, UPLC, GC) to ensure specificity and accuracy for impurity detection.
• Quality Control (QC) Testing: Used as a system suitability standard and for preparing calibration curves in routine QC testing to monitor batch-to-batch consistency.
• Stability Studies: Employed to identify and track degradation products that may form during the forced degradation and long-term stability studies of disaccharide-containing formulations.
• Regulatory Submissions: Provides necessary data on impurity identity and levels to support Investigational New Drug (IND), New Drug Application (NDA), and other regulatory filings.
• Academic and Industrial Research: Supports metabolic studies, biochemical pathway analysis, and purity assessment of novel disaccharide compounds in research settings.

Basic Information

Item	Details
Product Name	Disaccharides Impurities
CAS No.	1093278-53-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Disaccharide Related Compound; Disaccharide Impurity Standard; Disaccharide Process Related Substance; Disaccharide Degradant; Disaccharide Reference Standard; Disaccharide Specified Impurity; (2R,3S,4R,5R)-2-[(2R,3S,4R,5R,6R)-4,5-Dihydroxy-2-(hydroxymethyl)-6-[(2R,3S,4R,5R)-4,5,6-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-6-(hydroxymethyl)oxane-3,4,5-triol (IUPAC-based); 1093278-53-5
EINECS	Contact for details

Quality Control

Every batch of Disaccharides Impurities (CAS 1093278-53-5) is manufactured under a strict quality management system and undergoes comprehensive analytical testing to ensure identity, purity, and consistency. Our products are suitable for use under current Good Manufacturing Practice (cGMP) guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results for purity, impurities, and identification is provided with each shipment and is available 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 anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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