Finished Product
Release Testing
Working with MOD3 Pharma gives pharma partners a secure launchpad for the successful release of OINDP drug products to the clinic.
Finished product release testing marks the critical final step of this intensive development process and is vital to ensure a product reaches the market in compliance with the highest standards, both in terms of efficacy and patient safety.
Our comprehensive approach combines the skill of our expert scientists and the capabilities of our exceptional analytical facilities to support the wide range of testing required in this phase.
This comprehensive suite of services equates to a thorough evaluation of potency, purity and performance, ensuring manufactured batches meet with regulatory expectations for a market-ready product. It starts with defining the specification for your product, continues through the development and validation of the specified methods, and ends with the release of your product to GMP standards. We help you define what needs doing, and then help you get it done.
Analytical methods:
- Pharmacopeial and internal HPLC methods for assay and related substances
- Headspace GC methods for residual solvents
- Residual water by Karl Fischer titration, USP <921>, method 1c
- Particle size distribution by laser diffraction, USP<429>
- Delivered Dose Uniformity, USP<601>
- Microbial enumeration tests, USP<61> and <62>
- Other testing as described in USP<5>, <601>, <905>, <1111>, <1601> and <1664.1>
- Other testing as described In FDA guidance documents
