Quality Standards in Brivaracetam API Manufacturing: A Complete Guide

Brivaracetam API: Manufacturing Quality Standards & Chiral Purity Guide

Key Takeaways:

• API Name: Brivaracetam (Antiepileptic / Racetam derivative).
• CAS Number: 357336-20-0.
• Critical Quality Attribute: Stereochemical purity (controlling the (2S, 4R) diastereomer).
• Sourcing Risk: Nitrosamine formation and residual solvent limits in CNS drugs.
• Supply Hub: Hyderabad, India (Bio-Synth).

Brivaracetam, a high-affinity synaptic vesicle protein 2A (SV2A) ligand, represents the next generation of antiepileptic drugs (AEDs). Unlike its predecessor Levetiracetam, Brivaracetam requires significantly more complex synthesis to maintain its specific (2S, 4R) stereochemistry.

For pharmaceutical companies sourcing this API in 2025, “Quality” is not just about assay limits—it is about Chiral Purity and Process Validation. Sourcing from a WHO-GMP certified facility in Hyderabad ensures that these critical parameters are met without the high cost of Western CDMOs.

This guide outlines the critical quality standards you must verify before approving a Brivaracetam supplier.

Technical Specifications: The “Gold Standard” Data Sheet

Brivaracetam is 10-30 times more potent than Levetiracetam, meaning impurity controls must be tighter. Below are the standard specifications expected by regulatory bodies (USFDA/EMA).

The 3 Pillars of Brivaracetam Quality

Manufacturing this Brivaracetam API involves complex asymmetric synthesis. Bio-Synth (Hyderabad) addresses the three biggest manufacturing challenges:

1. Stereochemical (Chiral) Purity

Brivaracetam has two chiral centers. A slight deviation in process temperature or reagents can lead to the formation of the inactive (2S, 4S) or (2R, 4S) diastereomers.

• The Standard: Buyers should demand an Enantiomeric Excess (ee) of >99.8%.
• The Check: Ensure your supplier uses Chiral HPLC for batch release testing.

2. Residual Solvents (ICH Q3C Guidelines)

As a CNS drug often prescribed for long-term therapy, minimizing Class 2 and Class 3 solvents is critical.

• The Risk: Incomplete drying during the final crystallization step.
• The Solution: Bio-Synth utilizes vacuum tray drying and validated Gas Chromatography (GC) methods to ensure solvents are well below ppm limits.

3. Nitrosamine Risk Assessment

While Brivaracetam’s structure is relatively stable, the reagents used in synthesis can introduce Nitrosamine risks.

• The 2026 Requirement: Suppliers must provide a “Nitrosamine Free” declaration supported by a risk assessment of the synthetic route.

Hyderabad: The Global Hub for High-Potency APIs

Why are global innovators flocking to Hyderabad’s Balanagar Industrial Area for Brivaracetam?

It is the ecosystem. Producing high-purity CNS drugs requires specialized reaction capabilities (like high-pressure hydrogenation) that are standard in Hyderabad’s API clusters.

• Regulatory Maturity: High density of USFDA-approved facilities.
• Cost Efficiency: Integrated supply of intermediates allows for competitive pricing without compromising the Quality Management System (QMS).

Buyer’s Checklist: Validating a Brivaracetam Source

Don’t just rely on the price tag. Use this checklist during your vendor audit:

• Isomer Control: Can they demonstrate the removal of the diastereomeric impurity in the final purification step?
• Particle Size Distribution (PSD): Do they offer micronized grades (d90 < 20 microns) for better bioavailability?
• Audit Readiness: Is the facility open for a customer quality audit?
• Regulatory Filing: Is the Tech Package ready for DMF filing in your target market?

Conclusion: Quality is Non-Negotiable in CNS Drugs

For antiepileptic formulations, batch-to-batch consistency is patient-critical. Sourcing Brivaracetam requires a partner who treats the API not as a commodity, but as a life-saving molecule.

Bio-Synth combines decades of process chemistry expertise with strict WHO-GMP compliance to deliver Brivaracetam API that meets the world’s toughest standards.

Ready to source WHO-GMP-compliant Brivaracetam API Price in India? Contact Bio-Synth today for bulk quotes, regulatory documentation, and CDMO collaboration.

FAQs

Q1. What is the CAS number for Brivaracetam API?
The CAS number for Brivaracetam is 357336-20-0.

Q2. Why is chiral purity critical in Brivaracetam manufacturing?

Brivaracetam contains two chiral centers, and only the (2S, 4R) stereoisomer is therapeutically active. The presence of other diastereomers can alter efficacy and safety, making Chiral HPLC testing a mandatory quality check.

Q3. Does Brivaracetam API require Nitrosamine Risk Assessment?

Yes. Under current FDA and EMA guidelines, all synthetic APIs, including Brivaracetam, require a Nitrosamine Risk Assessment to ensure no genotoxic impurities are formed during the manufacturing process.

Q4. Can Bio-Synth supply micronized Brivaracetam API?

Yes. To support bioavailability in oral formulations, Bio-Synth offers micronized grades of Brivaracetam with a strictly controlled Particle Size Distribution (PSD).