Development services
Alera labs offers a broad range of analytical and formulation development services that include preformulation development, formulation development, reformulation, stability studies, analytical method development, validation and transfer for a broad spectrum of pharma compounds. . We also offer standalone Analytical services for third party formulation products. Our QA team has a good understanding of the regulatory aspects of development services.
Services
- A wide range of chromatographic separation techniques (HPLC, GC, LC-MS, LC-MS/MS and IC) and detection techniques (UV, FL, MS, ELSD, RI, FID, etc.) to meet the requirement of different types of compounds
- Stability-indicating assay and/or related substances methods for drug substances & products
- Residual solvents by GC-MS
- Enantiomeric separation by normal phase HPLC & GC
- Method development, qualification, validation and transfer
- Stability storage, testing and data trending
- Isolation of impurities and purification of compounds
- Materials characterization
- Moisture content determination
- Spectroscopy (NMR, Mass, FTIR, GC-MS, UV, etc.)
