Clopidogrel hydrogen sulfate
Agrochemicals 2025-03-02
Clopidogrel Hydrogen Sulfate (CAS No. 120202-66-6)
1. Basic Information
- IUPAC Name: Methyl (2S)-2-(2-chlorophenyl)-2-(6,7-dihydro-4H-thieno[3,2-c]pyridin-5-yl)acetate hydrogen sulfate
- Molecular Formula: C₁₆H₁₆ClNO₂S·H₂SO₄
- Molecular Weight: 419.90 g/mol
- Appearance: White to off-white crystalline powder
- Optical Rotation: [α]²⁰D = +55° to +56° (c=2, methanol)
- Polymorphs: Form I (thermodynamically stable) and Form II
2. Physicochemical Properties
| Property | Specification |
|---|---|
| Melting Point | 184–188°C (Form I, dec.) |
| Solubility | – Water: ~50 mg/mL (25°C) |
| – Methanol: Freely soluble | |
| pKa | 4.5 (tertiary amine) |
| LogP (octanol/water) | 3.0 (free base) |
| Hygroscopicity | Slightly hygroscopic |
3. Pharmacopoeial Specifications
| Test | USP/EP Standard |
|---|---|
| Assay (HPLC) | 98.0–102.0% |
| Related Substances | ≤0.5% any individual impurity |
| Sulfate Content | 22.4–23.4% |
| Heavy Metals | ≤20 ppm |
4. Hazards (GHS Classification)
- Acute Toxicity: Oral LD₅₀ >2,000 mg/kg (rat)
- Reproductive Toxicity: Category 2 (H361d)
- Environmental Impact: Not classified
5. Storage & Handling
- Conditions: Tight containers, 15–30°C, protected from moisture
- Handling: Use PPE (gloves, mask) to avoid inhalation of dust
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