QUIZ #3: cGMPs in the Pharmaceutical Laboratory
Part One: USP General Notices
Answer each of the following questions with a short response.
Good luck!
- What is the minimum acceptable standard grade for laboratory
chemicals (reagents, not analytical standards) used in the conduct
of USP tests and assays?
- When an individual monograph specifies a certain apparatus
by commercial name, when is it acceptable to use a different apparatus?
- Is it necessary to identically prepare test and assay solutions
as per the monograph at all times? If not, please elaborate on
any alternatives.
- If an in-house FDA-approved alternate method of analysis is
used to analyze a compendial article and a question as to the
integrity of the result is raised, which test method is accepted
as being the authoritative (or conclusive) one - USP or FDA-approved
alternative?
- When is it necessary to dry a USP standard before using it
to perform an assay?
- Does the term "transfer" indicate quantitative or
qualitative manipulation of a substance?
- Define the term "concomitant".
- When it is necessary to accurately weigh a material, what
defines a suitable balance? That is, how accurate does the balance
have to be in the respective weight range to be considered suitable
for use?
- When performing titrations, what percentage of the Buret volume
must be used per trial to produce an acceptable result?
- Define the term "dried to constant weight" as it
relates to compendial tests.
- Define the term "ignite to constant weight" as it
relates to compendial tests.
- When using a test solution as an indicator for a test or assay,
what amount (mLs or drops) is generally to be used?
- Define the term negligible as it applies to the Pharmacopoeia.
- Define the following expression: (92:25:4:2).
- What does the expression (1 in 9) mean?
- What do the following abbreviations stand for:
"VS"
"TS"
- What type of water is to be used in tests and assays where
water is called for?
- When you are directed to "filter" a liquid, without
further qualification, the intent is that the liquid be filtered
through suitable filter paper or equivalent device until the filtrate
is _____________.
- Terms related to the "Odor" of an article refer
to the article after exposure to _____ for _____ minutes.
- What does the term "about" mean in relation to the
USP?
How did you do? After you have taken the Quiz, request the
answers via E-mail from accureg@regulatory.com.
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