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API Low Dose Detectability in Tablet
CHALLENGE:
Accurate quantification of low-dose Active Pharmaceutical Ingredients (APIs) is essential for ensuring the efficacy, safety, and quality control of pharmaceutical tablets. Precise measurement of these low concentrations is critical to maintain therapeutic effectiveness and regulatory compliance
SOLUTION:
Accurate quantification of low-dose Active Pharmaceutical Ingredients (APIs) is essential for ensuring the efficacy, safety, and quality control of pharmaceutical tablets. Precise measurement of these low concentrations is critical to maintain therapeutic effectiveness and regulatory compliance
SOLUTION:
(API & EXCPIENT)
Blue peak indicates the API & Red peak indicates the low detected API
Qualification of API : Marked formulation
| Total Weight of the tablet | 650mg |
| API 1 | 500 mg |
| API 2 | 1 mg |
| % Of API 2 In the tablet | 0.152% |
From the Table Low Dosage 0.152% API 2 is detected in the tablet
RESULT:
What We Attained
➢ In-house low dose detectability
➢ API & excipient particle size
➢ API & excipient polymorphism
➢ Compositional distribution of API and excipient
Insight obtained from the study
➢ Quantification of API and Excipients
➢ Formulation Optimization
➢ Quality Control
➢ Bioavailability Considerations
➢ Manufacturing Process Validation
➢ Stability Assessment
➢ Efficiency in Processing
➢ Regulatory Compliance
The outcomes of this project provide crucial support to our customer in achieving optimizing formulations by analyzing the quantification of API and Excipients in the tablet. Additionally, these results contribute to efficient quality control, formulation optimization, regulatory compliance, and process enhancement in the drug