Rivaroxaban API in Formulations: Why Particle Size & Purity Matter
Rivaroxaban API in Formulations: Why Particle Size & Purity Matter
For pharmaceutical manufacturers, Rivaroxaban API is a core ingredient in modern anticoagulant therapies. However, its particle size distribution (PSD) and purity levels directly determine the bioavailability, consistency, and regulatory acceptability of the finished product.
In this guide, we explain why particle control and purity matter and how leading Rivaroxaban API manufacturers in India, especially Hyderabad-based Bio-Synth, deliver WHO-GMP certified APIs trusted by global formulation companies.
For sourcing bulk quantities from one of the top Rivaroxaban API suppliers in India, explore:
👉 Rivaroxaban API Manufacturers & Suppliers in India
What Is Rivaroxaban API and Why Is It Important?
Understanding Rivaroxaban
Rivaroxaban API is a direct Factor Xa inhibitor used to treat and prevent:
- Deep vein thrombosis (DVT)
- Pulmonary embolism (PE)
- Stroke in atrial fibrillation patients
API Profile Summary
| Property | Value |
| Chemical Name | Rivaroxaban |
| Therapeutic Class | Anticoagulant |
| API Use | Blood thinner for oral dosage forms |
| CAS Number | 366789-02-8 |
| Molecular Formula | C19H18ClN3O5S |
| Mechanism of Action | Factor Xa inhibitor |
Due to its low solubility, particle size and purity heavily influence dissolution rate and absorption — making API quality essential for bioequivalent formulations.
Why Particle Size Matters in Rivaroxaban Formulations
Particle Size → Dissolution → Bioavailability
As a BCS Class II drug, dissolution is the rate-limiting step for Rivaroxaban absorption. Smaller, controlled particle size improves surface area, resulting in better dissolution and predictable pharmacokinetics.
Key Impacts of Particle Size in Formulation
- Uniform dissolution across batches
- Content uniformity during granulation/compression
- Reduced variability in PK behavior
- Improved stability over shelf life
Simplified Impact Map
| Particle Size | Dissolution | Bioavailability | Regulatory Compliance |
| Uncontrolled | Inconsistent | Low | High risk of failure |
| Controlled | Uniform | High | WHO-GMP compliant |
Regulatory bodies now treat PSD as a Critical Quality Attribute (CQA) for Rivaroxaban API manufacturers.
Why Purity Levels Define API Performance and Compliance
What Does Purity Mean in Rivaroxaban APIs?
Purity refers to the absence of impurities such as:
- Residual solvents
- Related substances
- Heavy metals
- Microbial contaminants
Even minor deviations can affect:
✔ Stability
✔ Assay consistency
✔ Dissolution profile
✔ Patient safety
Regulatory Thresholds
Rivaroxaban must comply with:
- US FDA
- EMA
- DCGI
- ICH Q3A/Q3B
Typical impurity thresholds:
- Individual impurity: <0.1% (w/w)
- Total impurities: <0.5% (w/w)
- Enantiomeric purity: >99%
Failure to meet these results in dossier rejection or delayed approvals.
Rivaroxaban Formulation Challenges — And How the Right API Solves Them
Common Challenges
- Failure in content uniformity
- Poor in-vivo bioavailability
- Accelerated stability failures
- Scale-up inconsistencies
These often point to uncontrolled PSD or insufficient purity.
Bio-Synth’s Solution
Bio-Synth, a trusted name among Rivaroxaban API manufacturers in India, provides:
- Consistent PSD (D90 <10 μm)
- Purity ≥99.5%
- HPLC, GC & laser diffraction analysis
- WHO-GMP + GLP-certified systems
✔ High-purity Rivaroxaban API suppliers like Bio-Synth help reduce formulation risks.
Why Indian API Manufacturers Like Bio-Synth Lead in Quality and Scale
India’s Strategic API Ecosystem
- 800+ pharma units in Hyderabad
- SEZs for APIs & intermediates
- Global logistics connectivity
This ensures:
- Raw material security
- Cost-efficient processes
- CDMO scalability
International Certifications & Reach
Bio-Synth supplies to:
- Europe
- LATAM
- Southeast Asia
- MENA
Fully aligned with:
- WHO-GMP
- ISO 9001
- PIC/S guidelines
Supplier Evaluation Checklist for Rivaroxaban API
Use this checklist to assess Rivaroxaban API suppliers in India:
| Criteria | Bio-Synth Compliance |
| WHO-GMP Certification | ✔ Yes |
| Particle Size Specification | ✔ D90 <10 µm |
| Purity (HPLC) | ✔ ≥99.5% |
| Regulatory Support (CoA, DMF) | ✔ Available |
| Batch Consistency | ✔ Proven |
| CDMO Flexibility | ✔ Full service |
Troubleshooting Rivaroxaban API-Linked Failures
Symptoms of Poor API Quality
- Incomplete dissolution
- Out-of-spec (OOS) assay
- Stability failures
- Delays in import approvals (missing DMF)
Key Questions to Ask Suppliers
- Do you provide a PSD report per batch?
- Is the API compliant with oral-solid formulations?
- Do you support regulator-friendly documentation?
FAQs :
-
Why do buyers trust Indian APIs like Rivaroxaban?
India provides WHO-GMP compliance, strong cost-efficiency, and consistent global documentation.
-
What is the ideal particle size for Rivaroxaban API?
Most formulators require D90 <10 μm for consistent dissolution and bioavailability.
-
How do impurities impact Rivaroxaban stability?
Even low-level impurities can trigger degradation, loss of potency, or discolouration — impacting regulatory approvals.
Final Thoughts: Partner with India’s Leading Manufacturer
India’s pharmaceutical leadership is powered by companies like Bio-Synth that combine scientific precision with global compliance. If you are sourcing Rivaroxaban API manufacturers, investing in purity, particle size control, and WHO-GMP qualification is essential.
For Rivaroxaban API price in India, bulk quotes, and CDMO collaboration:
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