Ensuring Analytical Precision: Lenacapavir Impurity Standards & Sodium Reference from Aquigen Bio

Ensuring Analytical Precision: Lenacapavir Impurity Standards & Sodium Reference from Aquigen Bio

As lenacapavir (GS‐6207/Sunlenca) gains momentum in HIV prevention and treatment, providing accurate reference standards becomes critical. Aquigen Bio offers high-purity impurity standards-Lenacapavir Impurity‐7, Impurity‐9-plus Lenacapavir Sodium, all designed to support method development, quality control, and regulatory compliance in pharmaceutical workflows.

What is Lenacapavir?
Lenacapavir is a first-in-class HIV‐1 capsid inhibitor, approved by the FDA in December 2022, and marketed under names like Sunlenca and Yeztugo. Its mechanism targets multiple stages of viral replication, and it's administered in long-acting injectable or oral forms-providing biannual protection as a pre‐exposure prophylaxis (PrEP) option

Lenacapavir Impurity Standards: Impurity‐7 & Impurity‐9
Aquigen Bio provides well-characterized impurity standards from the lenacapavir synthesis pathway:

• Lenacapavir Impurity‐7
https://aquigenbio.com/product/lenacapavir-impurity-7/
A key process-related impurity. Essential for:
Method validation via HPLC, LC‐MS

Monitoring trace impurities in batches

Ensuring compliance with pharmacopeial and regulatory thresholds (e.g. ICH Q3A)

• Lenacapavir Impurity‐9
https://aquigenbio.com/product/lenacapavir-impurity-9/
A critical degradation impurity that forms during stability studies. Used for:
Accelerated and long-term stability analysis

Forced-degradation studies

Quantitative reporting during regulatory submissions

These impurity standards enable accurate detection and quantification-ensuring analysts meet ICH Q3A/B and US FDA regulatory criteria

Lenacapavir Sodium: High-Purity API Reference
https://aquigenbio.com/product/lenacapavir-sodium/
Lenacapavir Sodium (CAS 2283356‐12‐5), the sodium salt form, is available from Aquigen Bio with >98% purity and comprehensive documentation. Applications include:
Reference standard in QC laboratories

Calibration standard for method validation (AMV)

ANDA filing material and pharmacopeial traceable reference

Supplied with full coA, MS/NMR data, and stability profiles, this standard supports both routine QC checks and high-level regulatory procedures

Why High-Quality Lenacapavir Standards Are Essential
Analytical Integrity: Minimize false positives and misidentification

Regulatory Security: Ready for support in DMF/ANDA/NDA dossiers

Risk Reduction: Track degradation and synthesis impurities during shelf life

Workflow Efficiency: Pre-characterized standards save lab time and promote compliance

High-quality CRM standards reduce development delays and strengthen lab credentials in the eyes of reviewers.

Conclusion
With lenacapavir gaining prominence as a breakthrough HIV therapeutic, having reliable impurity and API standards is no longer optional-it's essential. Aquigen Bio delivers robust, validated materials that help pharmaceutical labs uphold regulatory standards, reduce risk, and accelerate development. Explore their catalog to secure your analytical advantage.

Aquigen Bio Sciences
281/1, Plot No 41,
Hinjawadi - Pirangut Rd,
Kasar Amboli, Pirangut,
Pune, Maharashtra 412108
Visit: www.aquigenbio.com

Aquigen Bio Sciences stands as India's premier resource for high-quality N-Nitroso impurity standards, impelling advancements in pharmaceutical research and manufacturing. Specializing in providing precise impurity standards - including degradation impurities, process impurities, and deuterated isotopes - Aquigen Bio Sciences empowers the industry to comply with the most rigorous global regulations. The contract research organization's commitment to precision and reliability makes it the trusted partner for addressing complex issues like N-Nitroso impurities in pharmaceuticals.

This release was published on openPR.