Bupivacaine HCl

Bupivacaine Hydrochloride USP
Long-acting Local Anesthetic API for Surgical Precision

Key Specifications:

• CAS: 14252-80-3

• Formula: C₁₈H₂₈N₂O·HCl | M.W.: 324.89

• Purity: ≥99.5% (HPLC)

• pH (1% sol.): 4.0-6.0

• Optical Rotation: +5° to +8°

Critical Quality Controls:
✓ Enantiomeric Purity: S(-)-isomer >99%
✓ Particle Size: <50μm (Micronized Grade)
✓ Bacterial Endotoxins: <0.2 EU/mg
✓ Heavy Metals: <10ppm

Clinical Applications:
• Epidural anesthesia (0.25-0.75% solutions)
• Peripheral nerve blocks
• Postoperative pain control
• Obstetrical analgesia

Manufacturing Compliance:

• FDA-approved cGMP facility

• USP/EP/JP triple pharmacopeia standards

• Sterile API option (γ-irradiated)

Packaging:
1kg amber glass vials (nitrogen flushed)
5kg HDPE drums with oxygen absorber

Stability: 48-month shelf life at controlled room temperature

Competitive Advantages:

1. Lowest cardiotoxicity in amino amide class

2. Customized salt forms available

3. Complete impurity profile (EP 10.0)

4. Global regulatory support (USDMF #21743)