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What is the difference b/w OVI Solvents and Residual
Solvents in case of Gas Chromatogaphy and What is its
Detection Limit?
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Residual Solvents in pharmaceuticals are Organic volatile
chemicals that are used or produced in the manufacture of
drug substance or excipient or in the preparation of drug
product.
Residual solvents refer to the amount not removed during
the purification of the drug product.
Organic Volatile Impurities <467>
1.Proposed in PF 14(2) (1988)
2.Incorporated into 3rdSupplement to USP 22(1990)
3.Acceptance criteria based on relative toxicity.
now the new name is Residual solvents <467>
Organic Volatile impurities are
1.Dichloromethane(600ppm)
2.Chloroform(60ppm)
3.Trichloroethylene(80ppm)
4.1,4-Dioxane(380ppm)
these four solvents are OVI solvents
Remaining solvents are residual solvents.
These are classified into 4 classes
Class 1 Solvents are 5
Class 1 Solvents are 27
Class 1 Solvents are 27
but class 4 solvents not having toxicological data.
there are 5 Solvents
detection limit is very low.
| Is This Answer Correct ? | 37 Yes | 13 No |
Answer / poojitha
residual solvents and ovi both are same but traditionally
rs is changed in to ovi there is no difference between them
| Is This Answer Correct ? | 31 Yes | 18 No |
Answer / 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.
| Is This Answer Correct ? | 9 Yes | 4 No |
Answer / i.kizar ahamed
ovi: Organic volatile impurities called OVI. Its limit is
very low.
benzene, chloroform, 1,4-dioxane, ethylene oxide, methylene
chloride and trichloroethylene
RS:RESIDUAL SOLVENTS ,Theirs limits r high compared to ovi.
| Is This Answer Correct ? | 25 Yes | 21 No |
Answer / d.sambireddy
Organic volatile impurities called OVI. Its limit is
very low.
benzene, chloroform, 1,4-dioxane, ethylene oxide, methylene
chloride and trichloroethylene
The above solvents are now included in Residuval solvents
suppose these solvents we are using (or) are not using in
process but we determine the solvents because these sovents
are toxic. its PDE is very low
RS:RESIDUAL SOLVENTS ,Theirs limits r high compared to ovi.
| Is This Answer Correct ? | 11 Yes | 7 No |
Answer / venkatesh
For pharmacopeial purposes, residual solvents in
pharmaceuticals are defined as organic volatile chemicals
that are used or produced in the manufacture of drug
substances or excipients, or in the preparation of drug
products. The residual solvents are not completely removed
by practical manufacturing techniques. Appropriate
selection of the solvent for the synthesis of a drug
substance or an excipient may enhance the yield, or
determine characteristics such as crystal form, purity, and
solubility. Therefore, the solvent may sometimes be a
critical element in the synthetic process. This General
Chapter does not address solvents deliberately used as
excipients nor does it address solvates. However, the
content of solvents in such products should be evaluated
and justified.
| Is This Answer Correct ? | 4 Yes | 2 No |
both same but ovi solvent very low limit
rs solvents very high rs solvents 3 Class
I class toxic & hazaros not used proces
II Class caman solvents
III Class
| Is This Answer Correct ? | 2 Yes | 0 No |
Answer / r.ramalingeswararao
In old days residual solvents are called ovi. these ovi solvent having very low ppm levels...but up dation on guidelines ovi is call and changed as residual solvents becz so many different solvents are used in manufacturing process with different levels ppm ranges.so there is no difference between ovi and residual solvents....only termnalise changed but processing method entire same procedure.
| Is This Answer Correct ? | 0 Yes | 0 No |
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