Long-term stability testing

Stability—accelerated, long-term (stress studies generally not performed for drug product), statistical analysis Comprehensive summary table for batch profiles Specifications—methods, tests, limits, rationale, validation... 

Nanodroplets were then tested for stability under long-term storage at 2 - 8°C. Samples were stored over the span of 6 months followed by sizing on a Malvern Zetasizer. The figure above shows sizing up to 105 days and 115 days respectively. Note the size of samples appears stable in the range of 150-280 nm. 

Stability Such materials offer high thermal stability and long-term photostability. Bellcore Telecordia compliance (i.e., 1209, 1221) tested for less than 600 hr. at 85°C785 relative humidity (RH), solder temperature >230°C, and degradation temperature >350°C. 

Note A PTX-4 compn, prepd by the addition of Haleite to 30/70 Pentolite, also offered promise, but because of borderline stability in accelerated stability tests, it was decided that PTX-4 must be proven by long term storage to be acceptable for use in standard ammo Refs 1) W.R. Tomlinson, Properties of Ternary Mixtures of High Explosives PATR 1414 (1944) 2) A.J. Phillips, The Manufacture of... 

Some of the [Au(N,0)Cl2] derivatives, namely 58a, 59a and 59b, which have been tested for cytotoxic activity against various human tumor cell lines, have shown significant effects [144]. Compound 57 is a potential alternative to dimethylgold (III) P diketonates and can be used as a starting material for gold coatings by the CVD method [140]. Recent studies have shown that the long-term stability of these... 

Increasing the molecular weight of a copolymer containing 5% methyl acrylate (MA) from 100,000 to 1,000,000 daltons had little effect on silica stabilization effectiveness (see Table IX). Increasing the methyl acrylate content from 5% to 30% had also little effect on silica fines stabilization effectiveness. Acidizing substantially reduced the effectiveness of this class of copolymer. Results for the injection of 10,000 pore volumes of water indicated that silica fines elution from the test column was substantially reduced on a long-term basis. 

Proper selection of testing conditions revealed an outstanding efficiency of hindered amine stabilizers (HAS) [3,4] in the temperature range below 130°C as long-term heat stabilizers. 

---