The TPW is designed to prepare and analyze pharmaceutical solid dosage forms and intermediate granulations. The instrument uses a high shear homogenizer to disperse samples in a vessel containing 20-500 mL of solvent. This makes TPW ideal to efficiently extract analyte for:
- Tablet and Capsule Stability Indicating Assays
- Tablet and Capsule Content Uniformity
- Blend and Granulation Uniformity
The APW is intended for use testing pure Active Pharmaceutical Ingredients (APIs). It may be used in other situations where smaller solvent volume is required. The APW processes samples in 16mm X 100mm tubes. The instrument may be used for diverse applications, including:
- API assay
- API stability and other impurities
- Residual components
- Cleaning validation
- Creams and semi-solid dosage forms
- Drug loaded medical devices
- Other extractions for assay
Identity and analytical quantification are important control tests performed on a variety of dosage forms and intermediate processing steps. From incoming raw material identification to production support activities like granulation all the way to the finished dosage forms, content uniformity and assay results are constantly monitored. The types of research and testing required depends directly on the dosage form manufactured.
Fully compliant recording of all sample preparation steps according to FDA data integrity guidelines and 21 CFR Part 11 requirements. The software assists users in setting up multiple preparation runs, controls the automated preparation platforms, and protocols & reports all steps executed. Additionally, HPLC run lists can be automatically created in your HPLC analysis software for seamless data transfer.