Active Pharmaceutical Ingredient

Sitagliptin Phosphate — CAS 486460-32-6

Also known as: Januvia; Glactiv

GMP Certified IP / BP / EP / USP DPP-4 Inhibitor / Antidiabetic Aurangabad, India
Sitagliptin Phosphate API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Sitagliptin Phosphate IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 486460-32-6

Product Overview

Sitagliptin Phosphate is the phosphate salt form of sitagliptin, a highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor used in the management of type 2 diabetes mellitus. It enhances the incretin system to lower blood glucose in a glucose-dependent manner with minimal hypoglycemia risk. Mediocon Inc manufactures pharmacopoeial-grade Sitagliptin Phosphate at its GMP Aurangabad facility.

Therapeutic Applications
  • Type 2 diabetes mellitus management
  • DPP-4 enzyme inhibition
  • Glycemic control
  • Antidiabetic formulations

Technical Specifications

ParameterSpecification
CAS Number486460-32-6
Molecular FormulaC₁₆H₁₅F₆N₅O · H₃PO₄
Molecular Weight523.32 g/mol
GradeIP / BP / EP / USP
CategoryDPP-4 Inhibitor / Antidiabetic
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Mfg DateMAR 2025
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

Quality & Compliance

  • GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
  • Full pharmacopoeial compliance: IP / BP / EP / USP standards
  • Complete documentation: Certificate of Analysis (CoA), MSDS, Certificate of Origin
  • Stringent in-process quality control at every manufacturing stage
  • HPLC purity testing and spectroscopic identification (IR, NMR)
  • Cold-chain and controlled-environment storage facilities available
  • Exported to 40+ countries with full regulatory support
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