FDA Pharmaceutical Drug Testing of Iron Injection Products

Project Description

MULTIPLE PRODUCTS
MULTIPLE TESTS
FDA GMP Pharmaceutical Laboratory needed for FDA Compliance Testing of Iron Injection based finished products . As per FDA
requirements we have to prove the sameness between test product and
Reference product. We need to have characterization and sameness testing to be executed in a Testing Lab having good
experience in doing characterization and sameness studies for these IRON molecules.

As per literature, FDA guidance and our experience the below mentioned
tests have to be performed for both reference product and test product.

1. Electron diffraction (TEM)
2. X-Ray diffraction
3. Absorption spectroscopy
4. Mass spectroscopy
5. NMR
6. IR
7. Zeta potential and particle size by zeta sizer
8. GPC ( Molecular weight)
9. Particle height by Atomic force microscopy
10. Polarography
11. Degradation Kinetics

Based on testing lab prior experience on Iron sucrose characterization please
add other characterization techniques which we missed to capture.

Please share technical capabilities, quotation and lead time. If
require please share your technical team convenient time to have a call.

Project Information

Number:21-02135

Industry:Pharmaceuticals

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FDA Pharmaceutical Drug Testing of Iron Injection Products

Project Description

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