Description

Saxagliptin Hydrochloride Monohydrate is the active pharmaceutical ingredient (API) form of a potent and selective dipeptidyl peptidase-4 (DPP-4) inhibitor. This compound is critical for the formulation of high-quality, effective anti-diabetic medications, offering a crucial therapeutic option for managing type 2 diabetes. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of solid oral dosage forms, such as tablets.

Application

• Pharmaceutical API: Primary active ingredient in the commercial manufacture of anti-diabetic drugs (e.g., Onglyza®).
• Formulation Development: Used in R&D for developing new fixed-dose combination therapies and novel drug delivery systems.
• Reference Standard: Serves as a high-purity chemical reference standard for quality control and analytical method development in laboratories.
• Clinical Trial Material: Sourced for the production of batches used in clinical research and bioequivalence studies.
• Generic Drug Manufacturing: Essential for companies producing generic versions of saxagliptin-based medications post-patent expiry.

Basic Information

Product Name	Saxagliptin Hydrochloride Monohydrate
CAS No.	1370409-28-1
Molecular Formula	C18H25N3O2 • HCl • H2O
Molecular Weight	363.88 g/mol (Monohydrate)
Synonyms	(1S,3S,5S)-2-[(2S)-2-Amino-2-(3-hydroxy-1-adamantyl)acetyl]-2-azabicyclo[3.1.0]hexane-3-carbonitrile Hydrochloride Monohydrate; BMS-477118; Onglyza API; Saxagliptin HCl Monohydrate; DPP-4 Inhibitor Saxagliptin
EINECS	Contact for details

Quality Control

Our Saxagliptin Hydrochloride Monohydrate is manufactured under strict quality systems. Each batch is tested to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and microbiological quality is provided with every shipment to ensure full traceability and regulatory compliance for pharmaceutical use.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	4.0% - 6.0%
Related Substances (HPLC)	Individual impurity: NMT 0.15% Total impurities: NMT 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	< 20 ppm
Microbiological 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.