Parameter | Specification | Competitor A | Competitor B |
---|---|---|---|
Chemical Formula | C6H7ClN2 | Same | Same |
Purity Grade | ≥99.5% (Pharmaceutical) | ≥98% | ≥99% |
Thermal Stability | Stable up to 250°C | 200°C | 230°C |
3-Chloro-2,5-dimethylpyrazine serves critical functions in:
Parameter | Requirement |
---|---|
Storage Temperature | 2-8°C (long-term), ≤25°C (short-term) |
Solvent Compatibility | Compatible with ethanol (≤60%), PG, glycerin |
Challenge: Required stable pyrazine derivative for high-temperature processing (180°C+)
Solution: Customized 99.8% pure batch with enhanced thermal stabilizers
Outcome: 40% reduction in production rejects; 18-month stability certification achieved
Challenge: Needed impurity profile ≤0.2% for FDA submission
Solution: Developed chromatography-purified API intermediate
Result: Successful Phase III clinical trial material approval
Feature | Our Product | Generic Alternatives |
---|---|---|
Regulatory Support | Full DMF/CEP documentation | Limited to COA only |
Lead Time | 4-6 weeks (GMP batches) | 10-14 weeks |
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