Validating chromatographic

At the beginning of the gradient, with 99% A/1% B, the flow rate of B would be 0.5 l/min.

If the specifications of the pump don’t claim that, then don’t bother trying to use it for such columns without a flow splitter. column the pump must be able to deliver 2 l/min with precision, a more attainable figure (but still not one that all HPLC pumps do attain).

Dead volume is another concern, even if your pumps do have the requisite precision.

validating chromatographic-73validating chromatographic-83validating chromatographic-60

A forced degradation study is an essential step in the design of a regulatory compliant stability program for both drug substances and products, and was formalized as a regulatory requirement in ICH Guideline Q1A in 1993. We provide an update on world-wide regulatory requirements.

Also, we list all possible benefits of forced degradation studies to assess the stability of drugs and products.

Thin-layer chromatography (TLC) was widely used in the 1960s and 1970s for pesticide residue analysis, but only to a limited extent since gas–liquid chromatography (GLC) and high performance liquid chromatography (HPLC) have become readily available.

In recent years, there have been various developments in the quality of plate coating and in detection systems, as well as in extraction and cleanup methods, that make it possible to apply TLC according to the current international quality standards.

For problems with accessibility in using figures and illustrations, please contact the Salt Lake Technical Center at 801-233-4900.

These procedures were designed and tested for internal use by OSHA personnel.Diffusive samples are collected by exposing either SKC 575-002 Passive Samplers or 3M 3520 Organic Vapor Monitors (OVM) to workplace air.Samples are extracted with carbon disulfide and analyzed by GC using a flame ionization detector (FID)..The TLC methods described in this publication are intended for laboratories where irregular supply of electricity, lack of service or limited budget do not allow continuous use of GLC and HPLC techniques, and where application of mass spectrometric detection is not feasible.TLC analytical techniques allow for screening, semi-quantitative determination and confirmation of pesticide residues and other organic trace contaminants, and have only minor requirements on equipment and laboratory infrastructure.A validation study of the “worst case” may be considered acceptable.


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