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Subject: RE: Does anyone have a
Date: Mon, 28 Feb 2000 16:35:44 -0500
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A few questions in order to best craft a suitable answer:
What product parameter(s) are you seeking to analyze with this method -
purity, identity, concentration, mass balance, stability, etc..? Different
methods will yield different information; for example, CE and HPLC might
tell you purity but might not be suitable for identity; mass spec might be
great for identity but not for purity; if it is a lyophilized synthetic
product, you would likely need moisture and residual solvents for
calculating mass balance on each lot. Also, I am assuming you would be
seeking orthogonal methods to assay each of these parameters - typically,
regulatory agencies require two methods for determination of
purity/impurities and identity.
Also, for use as a stability-indicating assay, any method would need to be
challenged with purposefully degraded product then assessed for its ability
to detect (and perhaps quantitate, if needed) any degradants. This is best
done with product degraded to yield sufficient amount of degradants to see
should they be present (i.e. 25-30% degradation). It is a different study
from those whereby you place your product under accelerated conditions to
determine the likely degradation pathways, or to assess the ability of the
product to withstand stressed situations. A purposeful degradation study
should in fact be performed prior to those studies such that the methods you
use for testing those stressed samples are proven to be able to detect any
degradants that might be forming.
Finally, is this to be a product manufactured and tested under cGMP? Since
these methods are to be used for QC testing, it seems so. If so, I would
also assume you will be looking for analysis systems and methods that are
validatable (yes, this has become a word these days) within the limits of
your product specifications (i.e it won't be a useful method for
determination of purity to +/- 5% if your method is only capable to perform
+/- 10%).
Nadine Ritter
Director of Analytical Services
BioReliance
nritter@bioreliance.com
310-528-7840
> -----Original Message-----
> From: John Nechtman [SMTP:jnechtma@mail.mcg.edu]
> Sent: Monday, February 28, 2000 6:23 AM
> To: Recipients of ABRF List
> Subject: Does anyone have a
>
> Does anyone have a good Oligonucleotide QC method. I prefer HPLC, but also
> have access to a Mass Spec with negative ion mode.
> Price per run is also an issue.
> Thanks in advance,
> John Nechtman
> MCG
> MBCF
> Dept. BMB
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