
Product Name: Tianeptine Ethyl Ester Sulfate
Chemical name: 7-[(3-CHLORO-6-METHYL-5,5-DIOXIDO-6,11-DIHYDRODIBENZO[C,F][1,2]THIAZEPIN-11-YL)AMINO]HEPTANOIC ACID ETHYL ESTER SULFATE SALT
CAS No.: 66981-77-9
Assay: >98.5%
Formula: C23H29ClN2O4S H2SO4
Tianeptine Ethyl Ester Sulfate is an improved salt of Tianeptine. It is not hygroscopic so handling the powder is a lot easier. Since it is not as readily absorbed and excreted from the body, the sulfate salt allows for a more controlled release of the Tianeptine over longer periods. Rather than having to dose three times with rapid peak effects and rapidly falling effects, the sulfate salt allows for one dose to maintain plasma levels in the body much longer than the sodium salt. These improved characteristics make Tianeptine Sulfate a novel addition.
TEST ITEM | SPECIFICATION | RESULT |
Appearance | White or almost white micro-crystalline powder | White powder |
Solubility | Insoluble in the water and methanol | Complies |
Identification | By IR, to match with the standard. | Complies |
| The retention time of major peak of the sample solution corresponds to the standard | Complies |
Related substance | Individual impurity: Not more than 0.1% | 0.04% |
| Total impurities: Not more than 0.5% | 0.08% |
Residue on ignation | Not more than 0.2% | 0.01% |
Loss on drying | Not more than 1.0% | 0.18% |
Heavy metal | Not more than 20ppm | < 20ppm |
Assay (on anhydrous basis) | 98%-101% | 99.75% |

PRODUCT NAME | ||
TEST ITEMS | SPECIFICATION | RESULTS |
Description | White Or Almost White Crystalline Powder | White Powder |
Identification | Infrared Absorption | Positive |
Assay | 97.0~103.0% | 99.2% |
Melting Point | 33~37ºC | 34.5~36.5ºC |
Loss On Drying | 0.5%max | 0.30% |
Organic Volatile Impurities | 2500PPm max | <1000PPm |
Residual Solvents | Meet the requirements.(USP29) | Confirms |
Chromatographic purity | sum of impurities:3.0%max | <3.0% |
Conclusion | The specification conform with USP32 standard |


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