Teneligliptin Hydrobromide Hydrate API is an oral antidiabetic pharmaceutical active ingredient belonging to the dipeptidyl peptidase-4 (DPP-4) inhibitor class. It is used in pharmaceutical formulations for the management of type 2 diabetes mellitus.
The Indian Pharmacopoeia Commission identifies Teneligliptin Hydrobromide Hydrate as an antidiabetic substance with a molecular weight of approximately 628.9 g/mol for the specified hemipentahydrobromide hydrate form. The monograph specifies an assay range of 98.0%–102.0%, calculated on the anhydrous basis.
Swapnroop provides Teneligliptin Hydrobromide Hydrate API for pharmaceutical formulation, development, analytical research and manufacturing applications.
Teneligliptin is a DPP-4 inhibitor that enhances incretin activity by inhibiting the enzyme DPP-4. This contributes to glucose-dependent insulin secretion and helps regulate blood glucose levels.
The API is particularly relevant to pharmaceutical formulations intended for type 2 diabetes management.
Teneligliptin Hydrobromide Hydrate is the hydrobromide hydrate form of the active pharmaceutical ingredient Teneligliptin.
The Indian Pharmacopoeia Commission describes the substance as C₂₂H₃₀N₆OS, 2½ HBr, xH₂O, with a stated molecular weight of 628.9 g/mol for the monograph form.
Product Name: Teneligliptin Hydrobromide Hydrate
CAS Number: 1572583-29-9
Molecular Formula: C₂₂H₃₀N₆OS, 2½ HBr, xH₂O
Pharmacopoeial Molecular Weight: 628.9 g/mol
API Type: Small-Molecule API
Therapeutic Category: Antidiabetic
Drug Class: DPP-4 Inhibitor
Parent API: Teneligliptin
Teneligliptin CAS: 760937-92-6
Physical Description: Off-white to cream-coloured powder
The IPC monograph specifically describes the material as an off-white to cream-coloured powder.
Teneligliptin Hydrobromide Hydrate is primarily used in pharmaceutical formulations for type 2 diabetes mellitus.
Its pharmaceutical applications include:
The Indian Pharmacopoeia Commission classifies Teneligliptin Hydrobromide Hydrate under the antidiabetic category.
Teneligliptin Hydrobromide Hydrate has a defined Indian Pharmacopoeia specification with numerical requirements for assay, hydrobromic acid content, enantiomeric purity, heavy metals, sulphated ash, water and related impurities.
The IPC monograph specifies:
These are IPC-published monograph requirements and are therefore preferable to generic commercial specifications for this product page.
Swapnroop provides Teneligliptin Hydrobromide Hydrate API for pharmaceutical formulation and manufacturing applications.
Our quality-focused approach includes controlled manufacturing, analytical characterization and documentation aligned with applicable pharmaceutical requirements.
The API can support pharmaceutical companies involved in formulation development, generic drug manufacturing, analytical development and commercial pharmaceutical production.
Teneligliptin Hydrobromide Hydrate should be packaged in suitable pharmaceutical-grade, well-closed containers that protect the material from moisture, contamination and environmental exposure.
Storage conditions should follow validated stability data, applicable product specifications and batch-specific documentation.
Depending on customer and product requirements, documentation may include:
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | 4.0% – 6.0% |