Answer Posted / kaushal

There are many different solvents which are used in
pharmaceutical manufacturing. Previously this test was
called Organic Volatile Impurities (OVI). As most of you
probably already know, major changes to USP <467> are on
the horizon (July 1, 2007). These changes have been in the
works for a few years now, in an effort to harmonize USP
requirements to the European Pharmacopoeia (EP).

The first change is in the title of the Chapter itself:
Residual Solvents (RS) is replacing Organic Volatile
Impurities (OVI). The new RS chapter now potentially tests
for 53 individual solvents, instead of the four under OVI.
However, the test methodology has (in some ways) been
simplified, as the Chapter now describes only headspace
conditions for analysis, similar to the old OVI Method IV.

if you have given one product then how you determine the impurity in that?

747

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in which situation require to take incident in validation?

1728

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what is the extinction coefficient for Indomethacin or at 319nm wave length.

4074

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we can use expired sample for validation and analyst qualification?

819

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What is similarity factor?

1211

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A ha tc is actual defination of retention time?

1618

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Related substance method equivalency on control sample or spiked sample?

777

---

Colorimtry

1667

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how can give the expiry period and restadardisation of volumetric solution

2600

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Why perchloric acid used for potentiometric titration

2685

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What is the diference between residual solvents and organic volatile matter

2059

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What is the purpose of octyl silane columns?

4291

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before starting analytical method valodation what you checking? and how giving preference to start validation?

813

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could negative ions be produced by bombardment process in mass spectrometry?

1786

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why should we perform dissolution PVT calibration only by UV spectrometer, not by HPLC ?

1714

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