Stabilizer packages, composition

Special considerations chemical composition of filler surface affects nucleation of filler traces of heavy metals decrease thermal stability and cause discoloration siuface free energy of fillers determines interaction large difference in thermal properties of fillers and polymer may cause stress hydrotalcite is used as acid neutralizer with stabilizing packages anatase titanium dioxide decreases UV stability presence of transition metals (Ni, Zn, Fe, Co) affects thermal and UV stability calcium carbonate and talc were found to immobilize HALS stabilizers in PP with organic masterbatches such as ethylene diamine phosphate V-0 classification can be obtained with 20-25 wt%, at the same time tensile strength and impact strength are substantially reduced... 

Vinyl stabilizers can aggravate oxidation or Inhibit it. The same is true for pigments, some of which are prooxidants while others are antioxidants. To assure satisfactory odor in use, a chemically stable plasticizer should be selected the vinyl composition should be well stabilized during processing and antioxidants added to the formulation, if not already present in the "stabilizer package" used. To assess potential odor development, it is prudent to test every new vinyl formulation by heating in a closed bottle at 50 C for several days. 

Di-n-octyltin Maleate Polymer n Like the preceding tin stabilizer, this one, too, has been FDA-approved for use in food-packaging compositions up to 3 phr. 

An elastomeric closure is a packaging component that is, or may be, in direct contact with a drug product. Elastomer selection for parenteral packaging principally involves consideration of chemical, physical, and biological properties, with emphasis on the stability profile of the drug/container system. Typical elastomeric closure compositions are listed in Tables 1 1. Although certain packaging applications frequently call to mind certain elastomer types, it is not feasible to prescribe specific... 

In addition to a description of the manufacturing method, packaging, and stability data, the ANDA requires only the following a description of the components and composition of the dosage form to be marketed brief statements that identify the place where the drug is to be manufactured the name of the supplier of the active ingredients assurance that the... 

Even if LiPFe is replaced by more thermally stable salts, the thermal stability of passivation films on both the anode and the cathode would still keep the high-temperature limits lower than 90 °C, as do the thermal stability of the separator (<90 °C for polypropylene), the chemical stability of the insulating coatings/sealants used in the cell packaging, and the polymeric binder agents used in both cathode and anode composites. 

The application (or Type II DMF) should include a detailed description of the complete container closure system for the bulk drug substance as well as a description of the specific container, closure, all liners, inner seal, and desiccant (if any), and a description of the composition of each component. A reference to the appropriate indirect food additive regulation is typically considered sufficient to establish the safety of the materials of construction. The tests, methods, and criteria for the acceptance and release of each packaging component should be provided. Stability studies to establish a retest period for bulk drug substance in the proposed container closure system should be conducted with fillers or desiccant packs in place (if used). Smaller versions that simulate the actual container closure system may be used. 

Drug product Components, composition, specifications and analytical methods for inactive components, manufacturers, methods of manufacture and packaging, specifications and analytical methods for the drug product, stability. Methods validation package Environmental assessment Field copy certification... 

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