Pregabalin functions as a gamma-aminobutyric acid analogue utilized as a primary active pharmaceutical ingredient in central nervous system medications. The substance appears as a white to off-white crystalline powder with established solubility profiles in aqueous and organic media. Production processes involve strict stereochemical control to secure high enantiomeric purity required for downstream pharmaceutical synthesis.
Product Information
|
Parameter |
Specification Details |
|
IUPAC Name |
(3S)-3-(aminomethyl)-5-methylhexanoic acid |
|
CAS Number |
148553-50-8 |
|
Molecular Formula |
C8H17NO2 |
|
Molecular Weight |
159.23 g/mol |
|
Appearance |
White to off-white crystalline powder |
|
Solubility |
Freely soluble in water and in basic and acidic aqueous solutions |
|
Melting Point |
194°C to 196°C |
|
Optical Rotation |
+10.0° to +12.0° |
Quality & Specification
Assay: 98.5% to 101.5% calculated on the dried basis.
Chiral Purity: Enantiomeric excess exceeding 99.5% verified through chiral high-performance liquid chromatography.
Impurity Profile: Individual unknown impurities controlled below 0.10%, with total impurities maintained under 0.5% in compliance with International Council for Harmonisation guidelines.
Residual Solvents: Controlled strictly below ICH limits, utilizing gas chromatography methods for solvent residue detection.
Heavy Metals: Total heavy metals restricted to lower than 10 parts per million.
Loss on Drying: Maximum 0.5% determined after drying at 105°C for three hours.
Residue on Ignition: Maximum 0.1% determined on a one-gram sample.
Manufacturing & Supply
Synthesis Route: Employs asymmetric catalytic hydrogenation coupled with diastereomeric resolution to secure target stereochemistry.
Cleanroom Environment: Crystallization, isolation, and micronization operations execute inside ISO Class 8 cleanrooms to prevent particulate contamination.
Particle Size Reduction: Jet milling technology controls particle size distribution to achieve target D90 values, enhancing powder flowability and dissolution rates.
Batch Capacity: Commercial scale production ranges from multi-hundred-kilogram to metric-ton batches, ensuring batch-to-batch reproducibility.
In-Process Controls: Automated monitoring systems regulate reaction temperature, pressure, pH levels, and agitation speed throughout synthesis stages.
Documentation
Certificate of Analysis
Provided with every commercial batch detailing complete physical and chemical test results.
Drug Master File
Regulatory support documentation available for submission to health authorities.
Stability Data
Long-term and accelerated stability study records covering standard storage durations.
TSE/BSE Statement
Certification confirming the manufacturing process utilizes zero animal-derived raw materials.
Genotoxic Impurity Assessment
Comprehensive evaluation reports validating strict control of potential process-related risks.
Packaging
Inner Packaging: Double-layer medical-grade low-density polyethylene bags tied securely to isolate moisture and atmospheric exposure.
Net Weight: Standard commercial quantity of 25 kilograms per drum.
Outer Packaging: Fiber drums containing tamper-evident seals to protect contents during transit.
Storage Requirements: Maintained in tightly sealed containers protected from direct sunlight, humidity, and excessive heat.
Pharmaceutical Application
Neuropathic Pain Management: Active ingredient incorporated into oral solid dosage forms for treating diabetic peripheral neuropathy and post-herpetic neuralgia by binding to voltage-gated calcium channels in central nervous system tissues.
Anticonvulsant Therapy: Utilized in formulation pipelines as an adjunctive treatment for partial-onset seizures in adult patients, helping stabilize aberrant neuronal electrical firing.
Generalized Anxiety Regulation: Applied in specific regional pharmaceutical markets for managing generalized anxiety disorders, delivering sustained therapeutic outcomes through controlled release mechanisms.
FAQ
Q: What is the standard shelf life of this active pharmaceutical ingredient?
A: The validated shelf life is 36 months when stored under recommended environmental conditions in unopened original packaging.
Q: Is analytical method validation data available for review?
A: Complete analytical validation packages covering chromatographic purity, assay procedures, and residual solvent testing methods accompany technical documentation requests.
Q: How is particle size distribution customized for specific formulations?
A: Adjustable jet milling parameters allow particle size tuning to meet specific dissolution requirements for capsule or tablet manufacturing.
Q: What precautions prevent moisture absorption during storage?
A: Double polyethylene inner liners combined with fiber drums sealed with desiccant sachets maintain dry internal conditions.
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