IPCS criteria

The WHO/IPCS criteria monograph on nephrotoxicity (WHO/IPCS 1991) addresses nephrotoxicity in general, kidney structure and function, the mechanistic basis of chemically induced renal... 

A WHO/IPCS criteria document on human exposure assessment presents the concepts, rationale, and statistical and procedural methodologies for human exposure assessment, but does not give detailed guidance on technical issues regarding instrumental and laboratory methods (WHO/IPCS 2000). 

Other Customer Industry Application Specifications (AABUS). Often PCB customers have special requirements for their solder mask. These can be a modification of the IPC criteria or some additional requirement not included in the SM-840 document. There is a term used to describe these requirements as agreed between user and supplier (AABUS). The key word here is agreed, since both parties must be completely aware of the requirement and what it takes to achieve the required result. 

Off-line HPLC/UV detection is the most common analysis technique used to monitor the disappearance of SM(s) and formation of product(s). " " COR IPC criteria are usually expressed as a relative area percent (RAP) of SM to product. The IPC method should separate all the known impurities from the SM, but not necessarily from the product since minor impurities co-eluting with the product will not significantly affect the IPC result. This approach allows the development of shorter methods. The UV of the SM and/or critical impurities should be used as the HPLC detector setting (if possible) for the... 

A system suitability preparation is made at the reaction criteria before a COR sample is analyzed (e.g., if a reaction IPC criteria is <1 RAP SM to product). A product to SM mixture standard preparation is made at 99 parts product to 1 part SM in the linear range of the detector. Similar system suitability preparations were performed by Wrezel et al. for reaction conversion samples." " The analyst needs to know the anticipated concentration of the product or analyte in the process stream (e.g., if the anticipated concentration of the product in reaction solution is 50 mg/mL, then the SM concentration in solution should be < 0.5 mg/mL). This tells the analyst the reaction sample dilution factor needed to remain in the linear range of the detector. It is important to remember that during synthesis development and process optimization, the anticipated product, SM, and impurity concentrations may vary significantly. Figure 6 shows an example of a COR IPC chromatogram. It is important to note the number of process-related impurities in the chromatogram. 

Impurity determination IPCs are used to monitor the removal of critical impurities from the product-rich solution layer or by solvent extractions or cake washes. The IPC criteria are usually expressed as RAP of the impurities relative to product in the product-rich solution layer and concentration of the impurity in extracted solution or mother liquor. The use of an impurity profile IPC was... 

Each GTI matrix brings along its own unique set of challenges for method development and optimization. There are examples in the literature of trace levels analysis of sulfonic esters (alkylating agents) quantitated to low levels. Because a method works for a particular GTI does not means it can be applied generically for every synthesis containing that compound. Each GTI analyses must be evaluated on a case-by-case basis to determine if it can meet the process IPC criteria for specificity and sensitivity. 

The evaluation of dose-response relationships is a critical component of hazard characterization (OECD, 1989 ECETOC, 1992 US , 1997a IPCS, 1999). Evidence for a dose-response relationship is an important criterion in establishing a toxic reproductive effect. It includes the evaluation of data from both human and laboratory animal studies. Because quantitative data on human dose-response relationships are infrequently available, the dose-response evaluation is usually based on the assessment of data from tests performed using laboratory animals. However, if data are available in humans with a sufficient range of doses, dose-response relationships in humans can also be evaluated. 

The spread and slump for surface-mount adhesives may be measured according to IPC-SM-817, Method 4.5.5. According to this method, sets of adhesive dots (minimum three per set), 0.65 cm in diameter and 0.25-mm thick, are deposited (for example, by screen or stencil printing) on each of two frosted glass microscope slides. One sample is stored 50-70 minutes at 25 5°C and 50 5% relative humidity and then measured for spreading of the uncured adhesive. The second sample is cured and measured for the increase in pattern from the original dimensions. The acceptance criterion is an increase of less than 10% of the original diameter of the dot or pattern. 

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