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Method Development & Validation
Method Development & Validation
- Method Development and Validation By GCMS
- Method Development and Validation By HPLC
- Invitro Dissolution Profile
- Impurity profiling
Extractable and Leachable Study
Extractable and Leachable Study
- Unknown peak identification
- Method development
- method validation
- screening of leachables
- Control and simulation extraction study
Nitrosamine Testing
Nitrosamine Testing
- Screening of Nitrosamines
- Method Feasibility
- Method Development
- Method Validations
- Batch testing
Customized Studies
Customized Studies
- Nitrate & nitrite Content.
- Fluoride content
- Glass delamination studies
- Photostability studies
Elemental Impurities
Elemental Impurities
- Screening of Impurities
- Method development & Validation
- Elemental Impurity Risk Assessment
- Analytical Technology Transfer
- Batch testing
Deformulation Studies
Deformulation Studies
- Q1 sameness and components as per RLD product
- Q2 same componenet and composition in RLD product
- Concentration within 95-105% of RLD product
Characterization
Characterization
- Impurity isolation
- Structural elucidations
- Polymorphic study
- Direct mass by LCMS
- Reference standards, working standard characterization & qualification
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