Description

Lactulose Impurity 1 CAS NO 41847-61-4 is a high-purity chemical reference standard, specifically identified as a key impurity in the synthesis and quality control of Lactulose. This compound is critical for ensuring the purity, safety, and efficacy of Lactulose, a widely used pharmaceutical and nutraceutical ingredient. It is an essential material for analytical laboratories, quality assurance departments, and research institutions in the pharmaceutical, biotechnology, and fine chemical sectors.

Application

• Pharmaceutical Impurity Profiling and Method Development: Serves as a certified reference material for developing and validating HPLC, UPLC, and GC analytical methods to quantify impurities in Lactulose API and finished drug products.
• Quality Control and Release Testing: Used as a system suitability standard and for preparing calibration curves in the routine QC testing of Lactulose batches to ensure compliance with pharmacopeial monographs (USP, EP, JP).
• Stability Studies and Degradation Pathway Analysis: Employed to identify and monitor this specific impurity formed during the forced degradation and long-term stability studies of Lactulose formulations.
• Regulatory Submission and Compliance: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and demonstrate control of the manufacturing process.
• Chemical Synthesis Research: Acts as a reference compound for chemists optimizing Lactulose synthesis pathways to minimize the formation of this by-product.
• Academic and Contract Research: Supports fundamental research on carbohydrate chemistry and the analytical characterization of disaccharide impurities.

Basic Information

Item	Detail
Product Name	Lactulose Impurity 1
CAS No.	41847-61-4
Molecular Formula	C12H22O11
Molecular Weight	342.30 g/mol
Synonyms	4-O-β-D-Galactopyranosyl-D-fructose; Lactulose Related Compound A; 4-O-β-D-Galactopyranosylfructose; D-Galactopyranose, 4-O-β-D-galactopyranosyl-D-fructose; D-Fructose, 4-O-β-D-galactopyranosyl-; Lactulose isomer; Lactulose process impurity
EINECS	Contact for details

Quality Control

Every batch of Lactulose Impurity 1 is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including chromatographic purity assay and spectroscopic identification, to ensure it meets the exacting standards required for use as a reference material. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting batch-specific results for identity, purity, and impurities.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing desiccated at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.