Scapex Exports Pvt. Ltd.
830, 8th Floor, Sun Gravitas, Times of India Road,
Shyamal, Ahmedabad 380015, Gujarat, India
+91 9925522674 · info@scapexexports.com
CIN U46909GJ2025PTC164345
Shyamal, Ahmedabad 380015, Gujarat, India
+91 9925522674 · info@scapexexports.com
CIN U46909GJ2025PTC164345
Certificate of AnalysisStandard product specification
Teneligliptin Hydrobromide
Formulated product · ≥99% Pharma Grade
1. Product identity
| Product name | Teneligliptin Hydrobromide |
|---|---|
| C.A.S. number | Applicable to blend — on request |
| Grade / standard | ≥99% Pharma Grade |
| Description | White to off-white powder |
| Product group | Antidiabetic API |
| Category | Active Pharmaceutical Ingredients (APIs) |
| Country of origin | India |
| Packing | Bags, drums, carboys, IBC or ISO tank as applicable — customer-specified packing available |
| Storage | Cool, dry, well-ventilated place in tightly closed original packing |
2. Analytical specification
| S. No. | Test parameter | Specification | Typical result | Method |
|---|---|---|---|---|
| 1 | Description | White to off-white powder | Complies | Visual |
| 2 | Solubility | As per specification | Complies | Visual / Monograph |
| 3 | Assay | Not less than 99.0 % w/w | 99.18 | Titrimetry / Instrumental |
| 4 | Clarity & Colour of Solution | Clear; not more intensely coloured than reference | Complies | Visual (Monograph) |
| 5 | pH (1 % w/v aqueous solution) | As per monograph | 6.5 | Potentiometry |
| 6 | Water Content (Karl Fischer) | Not more than 0.5 % w/w | 0.16 | Karl Fischer titration |
| 7 | Melting Range / Point | As per monograph | Complies | Capillary method |
| 8 | Particle Size (d90) | As per specification | 94 µm | Laser diffraction |
3. Declaration
This document sets out the standard specification for Teneligliptin Hydrobromide and applies to all consignments of this product and grade supplied by Scapex Exports Pvt. Ltd. It is not a lot-specific release document; a lot-specific certificate carrying the analysis of the material actually shipped is issued with, and travels with, each consignment. Scapex Exports supplies against customer-specified assay limits and pharmacopoeial standards — send your specification sheet and we confirm compliance in writing before the order is accepted.
SCAPEXQUALITY ASSURED