Description

Acarbose (Sulfate) is a potent α-glucosidase inhibitor, a key active pharmaceutical ingredient (API) used in the management of type 2 diabetes. Its primary value lies in its ability to delay carbohydrate digestion and absorption, thereby helping to control postprandial blood glucose levels. This compound is essential for pharmaceutical manufacturers developing oral anti-diabetic medications, particularly for the production of finished dosage forms like tablets.

Application

• Pharmaceutical API: Primary use as the active ingredient in oral anti-diabetic drugs for the treatment of type 2 diabetes mellitus.
• Blood Glucose Management: Formulated into tablets and other solid dosage forms to help control postprandial hyperglycemia.
• Metabolic Disorder Research: Used as a reference standard and research tool in biochemical and pharmacological studies of carbohydrate metabolism and enzyme inhibition.
• Generic Drug Manufacturing: Critical for the production of generic versions of acarbose-based medications, ensuring cost-effective treatment options.
• Combination Therapies: Potential use in combination with other anti-diabetic agents in fixed-dose combination products.

Basic Information

Product Name	Acarbose (Sulfate)
CAS No.	1221158-13-9
Molecular Formula	C25H43NO18 • xH2SO4
Molecular Weight	645.60 g/mol (for Acarbose base)
Synonyms	Acarbose Sulfate Salt; Acarbose Sulphate; Glucobay (Brand Name); Precose (Brand Name); O-4,6-Dideoxy-4-[[[1S,4R,5S,6S]-4,5,6-trihydroxy-3-(hydroxymethyl)-2-cyclohexen-1-yl]amino]-α-D-glucopyranosyl-(1→4)-O-α-D-glucopyranosyl-(1→4)-D-glucopyranose sulfate; α-Glucosidase Inhibitor; Bay g 5421
EINECS	Contact for details

Quality Control

Our Acarbose (Sulfate) is manufactured under strict quality systems suitable for pharmaceutical applications. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and potency meet stringent specifications. We provide full traceability and support regulatory submissions with comprehensive documentation, including detailed Certificates of Analysis (COA) and Drug Master File (DMF) support where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption, which can affect stability and handling properties.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 10.0 %
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Sulfate Content	Conforms to theoretical range
Heavy Metals	≤ 20 ppm
Microbial Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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