The Challenge
The Challenge
The pharmaceutical industry was facing these challenges:
- Which technique to use for particle size analysis?
- How to do particle characterisation?
- How to differentiate isolated particles from agglomerates?
- A 21CFR Part 11 Compliant Solution
- Do you like to know the percentage of API in formulation?
- Is possible classification of API, Excipient, Globule & multiple API in formulation product?
- Do you have complete automatic scanning?
The Solution
The Solution
The ipvAutoClass offers the following solutions.
- The microscopy technique in ipvAutoClass is reliable & more accurate for particle size.
- Our system is a 21CFR Part 11 Compliant solution
- The ipvAutoClass provides fully automatic scanning
- It provides morphological characteristics of particles like size, shape, texture, intensity, solidity, and circularity.
- Our system follows USP 776.
- Particle Size & Globule Size analysis can be performed easily.
- All kinds of dosage forms can be possible.
- Along with D10, D50, and D90, the ipvAutoClass provides the D1 to D100 values.
Benefits
Check out the advantages of ipvAutoClass: Automatic Microscopic Particle Classifier:
The ipvAutoClass helps in new drug development
Auto-focusing & auto image capturing facility with a high-end microscope is possible.
With ipvAutoClass, reduced manual intervention is possible
It saves time & reduces human effort.
It helps for FDA approval.
It also assists in ANDA filing.
