Levoxyl, a brand of levothyroxine, undergoes rigorous manufacturing to ensure consistent potency and purity. The process begins with precise weighing and mixing of high-quality raw materials. These materials are subjected to multiple purity tests before entering the manufacturing process. Automated systems meticulously blend the ingredients, guaranteeing uniform distribution.
Tablet Compression and Coating
The blended mixture is then compressed into tablets using specialized machinery. Each tablet’s weight and dimensions are monitored throughout this stage. Following compression, a protective coating is applied to ensure stability and prevent degradation, protecting the levothyroxine from moisture and light. This coating is also carefully controlled to ensure consistent drug release.
Quality Assurance Testing
Extensive quality control procedures occur at each production phase. These include tests for:
- Potency: verifying the correct amount of levothyroxine in each tablet Purity: ensuring the absence of impurities Dissolution: measuring the rate at which the levothyroxine dissolves, affecting bioavailability Tablet integrity: assessing tablet hardness, friability, and appearance
Final Product Release
Only batches passing all quality control checkpoints receive release for distribution. This stringent approach maintains consistent product quality. Data from every stage is meticulously documented and analyzed to continually improve the manufacturing process.
Summary of Key Quality Control Steps
| Raw Material Analysis | Verify purity and identity of starting materials |
| In-Process Controls | Monitor critical steps for consistency |
| Tablet Testing | Assess weight, hardness, disintegration, and dissolution |
| Stability Testing | Determine shelf life and storage conditions |
| Final Product Assay | Confirm potency and purity of final product |
Packaging and Distribution
Finally, the approved tablets are packaged according to strict guidelines, ensuring product protection during shipping and storage. This comprehensive approach guarantees patients receive a reliable and high-quality medication.
