Description

Lactitol Ep Impurity B CAS NO 53796-37-5 is a high-purity reference standard used for the identification and quantification of a specific process-related impurity in Lactitol, a sugar alcohol. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical-grade Lactitol. It is an essential material for analytical laboratories, quality control departments, and research facilities in the pharmaceutical and fine chemical industries focused on method development, validation, and impurity profiling.

Application

• Primary use as a certified reference standard (CRS) for pharmacopeial testing (EP, USP).
• Analytical method development and validation for Lactitol impurity profiling.
• Quality control and batch release testing in pharmaceutical manufacturing.
• Calibration of analytical instruments (HPLC, UPLC) for precise quantification.
• Research and development of purification processes for Lactitol.
• Stability studies to monitor impurity levels in drug substances over time.

Basic Information

Product Name	Lactitol Ep Impurity B
CAS No.	53796-37-5
Molecular Formula	C12H24O11
Molecular Weight	344.31 g/mol
Synonyms	4-O-β-D-Galactopyranosyl-D-glucitol; Lactitol impurity B; 4-O-β-D-Galactopyranosyl-D-sorbitol; Lactitol related compound B; D-Glucitol, 4-O-β-D-galactopyranosyl-; Lactitol EP Impurity B
EINECS	Contact for details

Quality Control

Every batch of Lactitol Ep Impurity B is manufactured and tested to meet the stringent requirements for pharmaceutical reference standards. Our quality system ensures identity, purity, and stability are fully characterized. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from advanced analytical techniques including HPLC, NMR, and MS. We support compliance with EP (European Pharmacopoeia) and ICH Q3A/B guidelines.

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); ensure the container is sealed after each use to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time conforms to reference standard
Assay (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%

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