Extractables from packaging

Several dosage forms carry an increased risk of degradation or adjunct formation. Products such as injections and aerosols are more likely to interact with volatiles or extractables from packaging and closure systems. Tablets have the potential to form adjuncts with excipients (specifically, lactose has been shown to form adjuncts in tablets). Non-CFC propellants in aerosols have a large number of impurities that typically do not interact with drug substances, but the potential for these interactions does still exist. Creams, ointments, lotions, and other such products will each have specific interactions that should be considered while evaluating the impurity profile of a drug product. 

Blends (lactose carrier) Advantages Powder can be easily extracted from packaging Inclusion of the carrier phase usually facilitates dispersion... 

Jenke, D. Organic extractables from packaging materials chromatographic methods used for identification and quantification. J. Liq. Chromatogr. Relat. Technol. 2003, 26 (15), 2449-2464. 

Organic Extractables from Packaging Materials Chromatographic Methc Identification and Quantification... 

Extracts from the British Standards Packaging Code BS 1133, Section 7 1967 and Section 19 1968 quoted in this section are reproduced by permission of the British Standards Institution, 2, Park Street, London, WlA 2BS, from whom copies of the complete standard may be obtained. 

API extracted from plant sources Collection of plants Cutting and initial extraction(s) Introduction of the API Starting Material into process Isolation and purification Physical processing. and packaging... 

Applications Although Soxtec combines the best qualities of reflux and Soxhlet extractions up to now fairly little evidence has been reported concerning the efficacy of this system for polymer and rubber analysis. Nevertheless, it appears that oligomers and other reaction residues, softeners, antioxidants (e.g. BHT) and several other additives used to modify polymers are easily extracted from PVC, PP, PE, PS, rubber and many other polymeric materials. Also, some leading international plastic, rubber and packaging companies have made Soxtec an integral part of their quality control routines. Some application examples where Soxtec has proved successful are [148] ... 

Many analytical techniques are in use for the qualitative and quantitative evaluation of monomers and oligomers extracted from PA6 (GC, differential refrac-tometry, IR, PC, SEC, HPLC, RPLC, etc.). FTIR has been used for quantitative analysis of caprolactam oligomer content (extract %) in polyamide-6 [113], The method, which involves a 3h extraction in boiling methanol, is suitable for process control and plant environment. Kolnaar [114] has used FTIR characterisation of fractional extracts with pentane, hexane, and heptane of HDPE for blow moulding applications. Vinyl acetate in packaging film has similarly been determined by quantitative FUR. 

Yang et al. [389] rapidly distinguished compounds extracted from paper, using on-line SFE-SFC-FHR in conjunction with principal component analysis. The quantitative determination of the surfactant mixture Triton X-100 and other complex oligoether surfactants by means of cSFC-FTIR flow-cells has been reported [390,391]. Practical applications of SFC-FTIR include the determination of nonvolatile compounds from microwave-susceptible packaging that may migrate into heated food. Another application is the analysis of fibre finishes on fibre/textile matrices. 

To summarize this pattern, extract from each class a definition of the minimal specifications of each type of object it needs to work with. This separates the roles played by each class, and they can be packaged more easily. 

The discrete microhotplates were packaged and bonded in a DIL-28 package for temperature sensor cahbration. A Pt-lOO-temperature sensor was attached to the chip package in close vicinity to the sensors. The chips were then caHbrated in an oven at temperatures up to 325 °C with the help of the Pt-100 resistor. A second-order polynomial was extracted from the measurements for each temperature sensor providing the temperature coefficients i and a2. ... 

Nylon microwave and roasting bags were reported to release, at cooking temperatures, volatile compounds, such as Nylon 6,6 cyclic monomer and cyclic oligomers up to the tetramer, and Nylon 6 monomer and cyclic oligomers up to the octamer. The same non-volatile compounds (except Nylon 6 heptamer and octamer) were extracted from the same packages (Soto-Valdez et al., 1997). 

The dose is extracted from the bulk powder drug package,... 

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