NDA/ANDA/OTC Support:

• Stability monitoring and analysis
• Monograph testing
• Packaging material analysis

Method Development:

• Extensive experience with method development and validation, completed by client target date and within budget.
• Impurity and degradant validation.
• Dissolution method validation
• API / Finished product assay and related validations
• Cleaning/ Rinse validation
• Impurity ID by LCMS MS/GCMS

Routine testing

• Assay / Content uniformity (HPLC / UV / GC)
• Assay (Potentiometry / Manual titration)
• Dissolution (Normal/extended/sustained)
• Chromatographic purity / Related substances
• Residual organic solvents / Organic volatile impurities
• Rinse and Swab analysis in cleaning validation.
• Packaging material analysis.

Microbiological testing

• Microbial limit
• Bioburden
• Sterility
• Bacterial endotoxin
• Preservative efficacy
• Microbiological assay of antibiotics
• Water analysis for microbial count.
• Particulate matter by microscopy
• MLT, Assay, Sterility, BET Method validations.

Compendial / Non compendial testing of Raw material and Finished product

Impurity characterization

• LC MS-MS
• GC MS-MS
• FTIR
• HPLC for chromatographic purity
• Elemental Analysis
• XRD
• NMR