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Items | Specifications |
Appearance | A white to off white powder |
Identification | Meets the requirement |
IR:similar ro Reference Substance | |
Loss on drying | ≤0.5% |
Specific optical rotation | +10.0° ~ +13.0° |
Related substance | Any single Impurity: ≤0.1% |
Total Impurity: ≤0.8% | |
Purity By HPLC R-isomer | ≤0.15% |
Residue on ignition | ≤0.1% |
Residual solvents | Isopropyl alcohol≤5000ppm |
Ethyl Acetate≤5000ppm | |
Heavy metal | ≤10ppm |
Chlorides | ≤0.05% |
Particle size | 50μm≤d(4.3) ≤150μm |
D(0.9)≤350μm | |
Assay by HPLC | 98.0%~102.0% |
Pregabalin is a new anticonvulsant therapy which holds promise as a safe and effective adjunct drug for seizure control in epileptic dogs.
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