Description

Miglitol-D4 Hydrochloride CAS NO 1346597-27-0 is a high-purity, deuterium-labeled isotopologue of the α-glucosidase inhibitor Miglitol, serving as a critical internal standard for precise quantitative analysis. This compound is essential for ensuring accuracy and reliability in pharmacokinetic and metabolic studies, particularly in drug development and clinical research. It is primarily required by pharmaceutical R&D laboratories, contract research organizations (CROs), and analytical service providers engaged in bioanalytical method development and validation.

Application

• Internal Standard for LC-MS/MS Analysis: Used as a stable isotope-labeled internal standard for the accurate quantification of Miglitol in complex biological matrices like plasma, serum, and urine.
• Pharmacokinetic (PK) and Bioavailability Studies: Enables precise tracking of drug absorption, distribution, metabolism, and excretion (ADME) profiles in preclinical and clinical trials.
• Metabolite Identification and Profiling: Aids in distinguishing drug-derived metabolites from endogenous compounds in mass spectrometry-based assays.
• Bioanalytical Method Development and Validation: Critical for developing robust, sensitive, and specific HPLC or UPLC methods compliant with FDA, EMA, and ICH guidelines.
• Quality Control in Pharmaceutical Manufacturing: Supports impurity profiling and stability testing of Miglitol active pharmaceutical ingredient (API) and finished dosage forms.
• Clinical Research on Diabetes Management: Facilitates research into the efficacy and safety of Miglitol and related anti-diabetic therapies.

Basic Information

Product Name	Miglitol-D4 Hydrochloride
CAS No.	1346597-27-0
Molecular Formula	C8H13D4NO5 • HCl
Molecular Weight	~275.71 g/mol
Synonyms	Miglitol-d4 HCl; (2R,3R,4R,5S)-1-(2-Hydroxyethyl)-2-(hydroxymethyl)-3,4,5-piperidinetriol-d4 hydrochloride; 1-Deoxynojirimycin derivative-d4 hydrochloride; Bay m 1099-d4 hydrochloride; Glyset-d4 hydrochloride; Deuterated Miglitol Hydrochloride; Miglitol (tetradeuterated) hydrochloride
EINECS	Contact for details

Quality Control

Our Miglitol-D4 Hydrochloride is manufactured under strict quality systems to ensure the high chemical and isotopic purity required for analytical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing parameters such as isotopic enrichment, chemical purity, and absence of interfering impurities. We adhere to relevant industry standards for reference materials, and our quality commitment ensures data integrity for your regulatory submissions.

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 product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Purity (HPLC)	≥98.0%
Isotopic Enrichment (MS)	≥98.0 atom % D
Water Content (KF)	≤2.0%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm

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