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Pregabalin is an antiepileptic drug, which is mainly used to treat postherpetic neuralgia.
Pregabalin is a gamma-aminobutyric acid (GABA) analog used as an anticonvulsant, anxiolytic, and analgesic drug. It is primarily prescribed for neuropathic pain, fibromyalgia, and generalized anxiety disorder (GAD). This document provides key physicochemical, pharmacological, and regulatory data for pharmaceutical-grade pregabalin.
| Property | Specification | Test Method |
|---|---|---|
| Chemical Name | (S)-3-(Aminomethyl)-5-methylhexanoic acid | IUPAC nomenclature |
| Molecular Formula | C₈H₁₇NO₂ | Elemental analysis |
| Molecular Weight | 159.23 g/mol | Mass spectrometry |
| Appearance | White to off-white crystalline powder | Visual inspection |
| Solubility (25°C) | Freely soluble in water (>100 mg/mL) | USP <911> |
| Parameter | Value/Description | Reference Standard |
|---|---|---|
| Mechanism of Action | Binds to α₂-δ subunit of voltage-gated calcium channels | FDA label |
| Bioavailability | ≥90% (oral) | Clinical studies |
| Half-life (t₁/₂) | 6.3 hours | Pharmacokinetic data |
| Protein Binding | <1% | In vitro studies |
| Metabolism | Negligible (excreted unchanged) | EMA assessment report |
| Medical Condition | Recommended Dosage | Maximum Daily Dose |
|---|---|---|
| Neuropathic pain | 150–600 mg/day (divided doses) | 600 mg |
| Fibromyalgia | 300–450 mg/day | 450 mg |
| Generalized Anxiety Disorder (GAD) | 150–600 mg/day | 600 mg |
| Adjunctive epilepsy therapy | 150–600 mg/day | 600 mg |
| Standard | Requirement | Compliance Status |
|---|---|---|
| USP-NF | Meets monograph standards | Compliant |
| Ph. Eur. | Conforms to EP 10.0 | Compliant |
| JP 18 | Meets Japanese specifications | Compliant |
| ICH Q3D (Impurities) | Heavy metals <10 ppm | Compliant |
| Residual Solvents | Class 2/3 limits per ICH Q3C | Compliant |
| Parameter | Specification |
|---|---|
| Storage temperature | 15–30°C (controlled room temp) |
| Shelf life | 36 months (unopened) |
| Light sensitivity | Protect from light |
| Packaging | HDPE bottles with desiccant |
| Regulatory status | FDA/EMA-approved prescription drug |
Pregabalin is a potent neuromodulator with well-established efficacy in chronic pain and anxiety disorders. Its favorable pharmacokinetics, minimal drug interactions, and high bioavailability make it a first-line therapeutic option.
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