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Plastic Materials of Construction
This monograph applies to the raw materials that go into making a packaging system. It requires testing of all raw materials (granules / sheets / resins etc.) of construction for the packaging material that is used in pharmaceutical container systems such as LDPE, HDPE, PET, Cyclic Oleofins, Polypropylene, PET, PVC etc. must be identified and characterized before use in manufacture of packaging material / container closure system.
Test as per USP 661.1
Identification using techniques such as IR and DSC;
Physicochemical tests
- Absorbance of extracts
- Total Organic Carbon
- Acidity / Alkalinity
Extractable Metals
Plastic Additives
Techniques used by
FTIR with polymer accessory from Agilent, DSC from Perkin Elmer capable of profiling polymers from -180 to 450 °C
- UV-Cary-600
- GE-Sievers 900
- Agilent 7800 ICP-MS
- Nexion 2000D
- Agilent 7700 ICP-MS
- Multiple techniques:
- Agilent 1290 UPLC
- Agilent LC / GC with QTOF/ QQQ
Instruments
