Ropivacaine Mesylate cGMP
Long-acting Local Anesthetic API for Surgical Applications

Key Specifications:

• CAS: 854057-55-5

• Formula: C??H??N?O·CH?O?S

• Purity: ≥99.8% (HPLC)

• Optical Rotation: +6.5° to +8.5° (20°C)

• Solubility: 50 mg/mL in water

Critical Quality Attributes:
? Enantiomeric Purity: >99.5% (S-isomer)
? Residual Solvents: <ICH Q3C limits
? Bacterial Endotoxins: <0.2 EU/mg

Clinical Applications:
? Epidural anesthesia (0.2-1% solutions)
? Peripheral nerve blocks
? Postoperative pain management
? Cesarean section anesthesia

Manufacturing Standards:

• ICH Q7 compliant synthesis

• ISO 13485:2016 certified facility

• Full DMF availability (USDMF #35621)

Packaging:
1kg/5kg nitrogen-purged amber vials
25kg HDPE drums with moisture barrier

Stability: 36-month shelf life at 15-25°C

Competitive Advantages:

1. Superior cardiotoxic profile vs bupivacaine

2. Customized particle size distribution (10-100μm)

3. Validated sterilization methods (γ-ray/EO)

4. Global regulatory support (USP/EP/ChP)