Overview
Sitagliptin Phosphate is an active pharmaceutical ingredient (API) primarily used for its antidiabetic properties. It plays a crucial role in the management of type 2 diabetes mellitus by enhancing the body’s ability to lower blood sugar levels. As a bulk pharmaceutical-grade material, it is produced under stringent manufacturing conditions to ensure quality and efficacy.
Therapeutic Application
This API is utilized in various formulations aimed at controlling blood glucose levels in patients with type 2 diabetes. Sitagliptin Phosphate works by inhibiting the enzyme DPP-4, which leads to increased levels of incretin hormones, thereby promoting insulin release and reducing glucagon levels.
Specifications
- CAS: 654671-78-0
- Appearance: White to off-white crystalline powder
- Typical Assay/Purity: ≥99.0%
- Common Pharmacopeial Grades: USP, EP, BP, IP
- Storage: Store in a cool, dry place, away from direct sunlight
- Shelf Life: Typically 2-3 years from the date of manufacture when stored under recommended conditions
Regulatory & Compliance
Sitagliptin Phosphate is manufactured in compliance with WHO-GMP standards. Documentation such as USDMF, CEP, and EU-GMP certifications may be available upon inquiry. Certificates of Analysis (COA) and Certificates of Suitability (COS) can also be provided, subject to request.
Packaging & Shipping
The API is packaged in 25kg HDPE drums with double LDPE liners to ensure product integrity during transit. The drums are palletized for secure shipping. All necessary export documentation is prepared to facilitate shipping to the USA, EU, Canada, and Japan.
Common Use Cases & Finished Dosage Forms
Sitagliptin Phosphate is commonly formulated into various dosage forms, including:
- Tablets
- Capsules
- Injections
These formulations are designed to provide effective management of blood glucose levels in diabetic patients.
Ordering Information
The minimum order quantity (MOQ) for Sitagliptin Phosphate is subject to inquiry. Interested parties can request a Certificate of Analysis (COA) and a quote through this listing. For further information, please contact Pharmint Exports directly.
