Apixaban is a selective Factor Xa inhibitor functioning as an oral anticoagulant designed for the prevention and treatment of thromboembolic conditions. Produced via validated multi-step synthetic routes, this specialty active pharmaceutical ingredient complies with international pharmacopoeial benchmarks. The material is supplied as a white to pale yellow crystalline powder optimized for direct compression and wet granulation in oral solid dosage manufacturing, ensuring consistent powder flow, low residual solvent levels, and reproducible dissolution profiles.
Technical Specifications
|
Parameter |
Specification / Detail |
Analytical Method |
|
Assay |
98.0% to 102.0% (dried basis) |
High-Performance Liquid Chromatography |
|
Appearance |
White to pale yellow crystalline powder |
Visual Inspection |
|
Loss on Drying |
Max 0.5% |
Gravimetric Analysis (105 degrees Celsius) |
|
Residue on Ignition |
Max 0.1% |
Pharmacopoeial Standard |
|
Heavy Metals |
Max 10 ppm |
Inductively Coupled Plasma Mass Spectrometry |
|
Individual Specified Impurity |
Max 0.10% |
High-Performance Liquid Chromatography |
|
Total Impurities |
Max 0.5% |
High-Performance Liquid Chromatography |
|
Residual Solvents |
Compliant with international limits |
Gas Chromatography |
|
Polymorphic Form |
Form I |
X-Ray Powder Diffraction |
|
Particle Size Distribution |
Custom profiles available (D90 below 50 micrometers) |
Laser Diffraction |
Manufacturing & Quality Assurance
Synthesis & Isolation: Manufactured in high-containment reaction units utilizing validated starting materials and rigorous multi-step purification protocols.
Controlled Environment: Processing, crystallization, drying, and micronization occur within ISO Class 8 cleanrooms, with final packaging conducted under ISO Class 5 laminar flow conditions.
Process Validation: Complete prospective process validation executed across commercial scale batches alongside continuous annual product quality reviews.
Supply Chain Stability: Multi-sourcing strategies for critical raw materials combined with established safety stock management guarantee uninterrupted delivery schedules.
Regulatory Documentation & Compliance
Batch Verification: Comprehensive Certificates of Analysis detailing complete physical and chemical test results accompany every shipment.
Regulatory Submissions: Open and closed part Drug Master Files maintained for immediate reference across global jurisdictions.
Safety & Hazard Data: Global Harmonized System compliant Safety Data Sheets detailing toxicological profiles and handling protocols.
Quality Declarations: Certified absence of animal-origin raw materials alongside verified compliance reports for residual solvents and heavy metals.
Stability Profiles: Long-term and accelerated stability study data available to support shelf-life verification.
Packaging & Storage Architecture
Primary Containment: Pharmaceutical-grade double low-density polyethylene bags, heat-sealed under tamper-evident conditions.
Secondary Containment: Rigid fiber or high-density polyethylene drums integrated with light-barrier foil liners.
Moisture Control: Food-grade silica gel desiccants positioned between primary and secondary layers to prevent moisture ingress.
Standard Packaging: 1 kg, 5 kg, and 25 kg net weight configurations per drum, with customizable sizing available upon request.
Storage Requirements: Store in tightly closed containers protected from light and moisture at controlled room temperatures between 15 and 30 degrees Celsius.
Pharmaceutical Applications
Stroke Prevention: Interrupts the coagulation cascade to prevent thrombin generation and blood clot formation in non-valvular atrial fibrillation management.
Thromboembolism Management: Delivers predictable pharmacokinetics for acute deep vein thrombosis and pulmonary embolism treatment, suppressing clot extension following initial therapy.
Postoperative Thromboprophylaxis: Suppresses activation of the coagulation pathway during periods of high immobilization risk following elective orthopedic surgeries.
Formulation Versatility: Optimized powder morphology supports uniform content distribution and reproducible disintegration rates in immediate-release film-coated tablet cores.
FAQ
Q: What regulatory documentation supports this active pharmaceutical ingredient?
A: A comprehensive Drug Master File is maintained for regulatory submissions, supported by batch-specific Certificates of Analysis, stability study reports, and impurity profiles aligned with international quality guidelines.
Q: How is polymorphic consistency maintained across production batches?
A: Crystallization parameters, thermal gradients, and solvent systems are strictly monitored and verified via X-Ray Powder Diffraction to guarantee stable Form I crystallization.
Q: Can particle size distribution profiles be tailored for specific manufacturing needs?
A: Yes. Mechanical micronization parameters are adjustable to achieve specific particle size distribution targets, such as D90 values below 50 micrometers, ensuring seamless integration into direct compression tablet formulations.
Q: What is the standard minimum order quantity for evaluation purposes?
A: Research and development sample quantities start at 100 grams, with commercial batch sizes scaled dynamically to match customer production forecasts.
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