tianeptine sulfate

Tianeptine Semisulfate Monohydrate
Optimized Salt Form for Neuropsychiatric Formulations

Key Attributes:

• CAS: 1224690-84-9

• Formula: C₂₁H₂₇ClN₂O₈S₂ | M.W.: 535.02

• Purity: ≥99.3% (HPLC)

• Crystal Structure: Triclinic P-1 (PXRD verified)

• Water Content: 3.5-4.5% (Karl Fischer)

Formulation Advantages:
✓ 40% enhanced aqueous solubility vs. free base
✓ Ideal for oral liquid formulations (pH 4.0-8.0)
✓ Low hygroscopicity (Δm <0.3% @60% RH)

Clinical Applications:
• Rapid-dissolve antidepressant tablets
• Long-acting injectable suspensions
• Geriatric-friendly dosage forms
• Cognitive enhancement combos

Compliance Ready:

• Complete ICH Q3D elemental profile

• 36-month stability data (25°C/60% RH)

• Available US DMF & EU ASMF access

• Microbial limits meet USP <61>/<62>

Specialized Packaging:
1kg vacuum-sealed aluminum pouches
5kg amber PET containers with silica gel

Regulatory Status:
• WHO PQ pre-qualified
• Japan PMDA certification pending
• Kosher/Halal compliance on request

Technical Edge:

1. Patent-pending purification process (WO2023056789)

2. Customizable particle size (10-500μm)

3. Full forced degradation studies available

4. Exclusive neuroprotection efficacy data