Explain about the Tests required for Raw material?
Explain about the Tests required for Raw material?
Replies to this topic (4)
1. Identity Testing
Organoleptic Properties
Chemical Fingerprinting
Solubility
2. Purity and Composition
Assay, Impurity Profile, Loss on Drying (LOD)
3. Physical Characterization
Particle Size Distribution (PSD), Bulk/Tapped Density, Viscosity
4. Microbiological Testing
Total Aerobic Microbial Count (TAMC), Pathogen Screening, Endotoxin Testing.
Raw material is called as Key starting material (KSM)
In pharma industry we will have bulk and formulation manufacturing.
For those, KSM is different
In bulk, we will have plant based, animal based or semi based starting materials.
Mostly, we will choose, plant based KSM in bulk where it's finished product is API (Active pharma ingredient) which is inturn itself is a KSM for formulation manufacturing.
So here, in the above you have asked
Mention whether you are asking about KSM or Raw material for bulk or formulation
There by, we could answer promptly
In any manufacturing, either bulk or formulation, we will have tests in common
They are
Qualitative Tests and Quantitative Tests
In Qualitative tests, we do for Identification of the desires material. Those are also called as
Identification tests.
Some of Qualitative tests include
Limit tests
pH
Identification tests by UV, IR,HPLC
Quantitative tests measures the amount of your compound, its purity and impurities quantity
The tests include
Impurities quantification by HPLC
Residual solvents quantification by GC
Karl Fischer titration analysis and Auto titration
Loss on drying
Sulfated ash
Along with those, we will have
Description analysis
Solubility analysis and Microbial testing.
So, here by talking API as a starting material we will have tests as
Description
Solubility
Identification (by UV, HPLC, IR)
Purity (Assay by HPLC, titration)
Impurities identification and Quantification (HPLC)
Residual solvents identification and Quantification (GC)
Water content and moisture content(KF,Auto titration, Loss on drying)
Sulfated ash
Inorganic contents ( Limit tests)
Microbial Analysis
Particle size analysis also included