fda cas 15499-84-0

FDA Status and Regulatory Information for CAS 15499-84-0 (9,9-Bis(4-aminophenyl)fluorene)

1. Substance Overview

Chemical Name: 9,9-Bis(4-aminophenyl)fluorene

CAS Number: 15499-84-0

Molecular Formula: C₂₅H₂₀N₂

Molecular Weight: 348.44 g/mol

Physical Properties: Melting point >300°C, density 1.245 g/cm³

2. Regulatory Status as of March 10, 2025

As of the current regulatory review cycle (Q1 2025), CAS 15499-84-0 has not been listed in the FDA’s:

• Inventory of Effective Food Contact Substances (FCS)
• Drug Master Files (DMF)
• Inactive Ingredient Database (IID)

3. Potential Regulatory Pathways

4. Compliance Considerations

For current Good Manufacturing Practice (cGMP) compliance:

1. Required purity: ≥98% (HPLC)
2. Residual solvent limits per ICH Q3C guidelines
3. Genotoxic impurity assessment per ICH M7

5. Recent Regulatory Updates

No FDA-related regulatory actions or guidance documents specific to this compound have been published in 2024-2025. Monitor:

• Federal Register notices
• FDA Substance Registration System (SRS)
• CDER/CBER Guidance Document Database

6. Recommended Action Steps

For regulatory compliance inquiries:

Contact FDA CDER Office of Pharmaceutical Quality: opq@fda.hhs.gov

Manufacturer Support: info@vivalr.com | Tel: (86) 15866781826