Drug Quality Control Manor 1-60 Flashcards - Quizlet

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10/27/21, 1:20 PM D g Q ali C n l Man 1-60 Fla hca d Q i le

D gQ a C Ma 1-60

Ge acce o all o r a , o r per onal progre da hboard and mar d hor c i h Q i le


Pl . U l ck P g e

Te h e (60)

Mo of he official dr g con aining calci m and


inc are a a ed b :
A
A) EDTA me hod B) Gra ime r
C) Nonaq eo i rime r D) Acidime r

T pe of alkaloidal a a here he o al alkaloid


are de ermined:

D A) Ul ima e
B) Specific
C) E rac ion
D) Pro ima e

Lim l ameoboc e l a e (LAL) a a me hod i


applicable in he de ermina ion of:

A A) P rogen
B) Chemical imp ri ie
C) Microorgani m
D) All of he abo e

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The mea remen of a ba e of a gi en ample b


i ra ion iha andard acid i :
A) Acidime r
A
B) Comple ime r
C) Alkalime r
D) Redo

The follo ing compo nd are a a ed b


acidime ricall , e cep :

C A) Sodi m h dro ide


B) Caffeine
C) Ci ric acid
D) Zinc o ide

Which of he follo ing b ance i a a ed b


re id al alkalime ric anal i ?

A A) A pirin
B) Sodi m h dro ide
C) H drochloric acid
D) Zinc o ide

A common ampling plan ha e ma er able


o in erpre he re l :

C A) 100% in pec ion


B) Sq are roo em
C) Mili ar andard
D) A and C

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Ma erial o be ampled incl de he follo ing,


e cep :

B A) Final prod c
B) Record
C) In ermedia e prod c
D) Ra ma erial

The proce of remo ing an appropria e n mber


of i em from a pop la ion in order o make
in erference o he
en ire pop la ion i called:
A
A) Sampling
B) In pec ion
C) S a i ic
D) None of he abo e

A ool for de ec ing aria ion in a proce :

A) Pie char
C
B) Bar char
C) Q ali con rol char
D) T-char

The Q ali Con rol Depar men i impor an o:


A) En re niform prod c ion of high q ali
prod c
D B) Safeg ard p blic heal h
C) En re ha minim m andard of he prod c
compl i h he BFAD req iremen
D) All of he abo e

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The f nc ion of Q ali Con rol incl de he


follo ing, e cep :

A) Anal ical con rol


C B) In pec ion con rol
C) A di ing
D) A and B

The QC manager i in charge of he follo ing


ec ion , e cep :

A A) Specifica ion and a a de elopmen


B) Anal ical e ing labora or
C) Re earch and de elopmen die
D) Biological e ing

The Fir -In Fir -O Polic m al a be


ob er ed o:
A) A re ha he olde ock i ed fir
B) Pre en con amina ion and mi - p of
A
ma erial
C) Con ain he informa ion regarding he ac i i
of he ac i e ingredien
D) All of he abo e

The Kjeldahl me hod of anal i i ed o


de ermine:

C A) Fa
B) S gar
C) Ni rogen
D) O gen in organic compo nd

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The a h con en of an organic compo nd i an


imp ri of:

C A) Carbon
B) Oil
C) Inorganic ma er
D) Vola ile componen

The iodine al e of oil i a q an i a i e mea re


of:

D A) Phenol con en
B) Sa ra ed fa acid
C) Un aponifiable ma er
D) Un a ra ed fa acid

Anal i herein he con i en of a ample are


epara ed and hen he prod c i eighed:
A) Vol me ric
B
B) Gra ime ric
C) Special me hod
D) Ga ome ric

The n mber of mg of KOH needed o ne rali e


he free acid and aponif he e er in 1g of oil
or fa :
C A) Acid al e
B) E er al e
C) Saponifica ion al e
D) Iodine al e

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The molec lar eigh of NaOH i 40. Ho man


gram of NaOH pelle are needed o make
500mL of 1.5N
ol ion?

B A) 20
B) 30
C) 40
D) 60

If 1mL of HCl i eq i alen o 1.5mL of 0.5N NaOH,


he ol me of he alkali ha o ld be con med
b 30mL of
B
acid i :

A) 4.5mL B) 45mL C) 20mL D) 30mL

The mo effec i e chemical b ance in


remo ing ain of po a i m permangana e:
A) O alic acid
A
B) Sodi m hio lfa e
C) Chalk
D) Vinegar

The e er al e de ermina ion of b ance i


applicable o he follo ing, e cep :

C A) Fa
B) Vola ile oil
C) Alcohol
D) Fa oil

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The follo ing are indica or ed for acid-ba e


i ra ion , e cep :

A) Me h l orange
C
B) Phenolph halein
C) Ferric al m
D) Me h l red

An acc ra el mea red ample of h drogen


pero ide 2g a di ol ed in a mi re of 20mL
a er and 20mL dil ed
lf ric acid and a i ra ed i h 0.1N po a i m
permangana e con ming 30mL o reach he
endpoin . Comp e for
A
he percen age of h drogen pero ide (MW=34):

A) 2.55%
B) 5.1%
C) 2.5%
D) 5.5%

Re id al me hod i ra ion i h EDTA i applicable


o ha me al ion:

A A) Calci m
B) Al min m
C) Zinc
D) Magne i m

Chemical reac ion ha in ol e a change in he


alence n mber of reac ing b ance :

C A) Ne rali a ion
B) Comple a ion
C) O ida ion-red c ion
D) Precipi a ion
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A proce herein he ample i made o libera e


iodine, hich i hen i ra ed iha andard
ol ion of odi m
hio lfa e:

C
A) Vol me ric i ra ion
B) Back i ra ion
C) Iodome r
D) Iodime r

A b re i h a gla opcock can be ed for:

A) Alcohol
B
B) Acid
C) Ba e
D) Sal

Malic acid pre en in cherr j ice ma be


de ermined b :

A A) Indirec permangana e o ida ion me hod


B) Direc permangana e o ida ion me hod
C) Alkalime r
D) Acidime r

Iodome r i an indirec anal i of:

A) O idi ing agen


A
B) Red cing agen
C) Acid
D) Ba e

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The n aponified ma er pre en in animal fa i :

A) Chole erol
A
B) Ph o erol
C) Lard
D) Wa

The bi lfi e me hod i ed in he a a of ola ile


oil o de ermine:

A A) Aldeh de con en
B) Acid con en
C) E er con en
D) S lf r con en

The cr de fiber of a dr g all con i of:

A) Cell lo e
A
B) Chole erol
C) Ph o erol
D) None of he abo e

In phenol con en de ermina ion of a ola ile oil,


he la er in he grad a ed neck of he Ca ia fla k
reached 2.7mL
ob ained from a ample of 10mL af er rea men
i h KOH ol ion. The percen age of oil i :
A

A) 73%
B) 69%
C) 7.3%
D) 27%

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Thi de ermine he helf life of a prod c :

A) Sampling in pec ion program


D
B) All of he an er
C) Valida ion program
D) S abili e ing program

Amo n of di ol ed dr g can be de ermined b :

A) Anal ical balance


B
B) Di ol ion e er
C) Brookefield i come er
D) DOP pra

Trace mineral in a m l i i amin prepara ion can


be a a ed fa er b :

A A) A omic Ab orp ion Spec ropho ome er C) Ga


Liq id Chroma ograph
B) UV-Vi Spec ropho ome er
D) High Pre re Liq id Chroma ograph

Po enc of a 100mg able a he e pir da e:

A) 95mg
B
B) 90mg
C) 105mg
D) 110mg

In pec ion a ion are placed in he follo ing


area , e cep :

A A) Anal ical labora or


B) Man fac ring area
C) Wareho e
D) Packaging area

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In he microbial a a of an ibio ic , he
microorgani m ed for Penicillin G i :

A) S aph lococc a re
A
B) P e domona aer gino a
C) E cherichia coli
D) Bacill b ili

The e pira ion da e i :

A) The direc applica ion and in erpre a ion of he


kno ledge gained from he abili e ing.
B) U ed o limi he period d ring hich a
C
prepara ion ma be e pec ed o ha e i labeled
po enc , pro ided i ha
been ored a direc ed.
C) A and B are correc
D) A and B are incorrec

The period of abili of a prepara ion i he ime


from he da e of man fac re of he form la ion
n il i chemical or
biological ac i i i no le han ___ of labeled
po enc :
A

A) 90%
B) 95%
C) 93%
D) 99%

Which i no con idered a a primar packaging


componen ?

D A) Bo le
B) Vial
C) Cap
D) Packer bo e
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Dr g b ance ha are i hheld from


di rib ion n il ba ch cer ifica ion from BFAD ha
been recei ed:
A A) An ibio ic
B) An ineopla ic
C) Vi amin
D) All of he abo e

Fac or ha can be manip la ed o accelera e


in abili :

D A) Tempera re
B) Moi re
C) Ligh
D) All of he abo e

Cro -e amina ion and mi p can happen in he


follo ing i a ion , e cep :
A) Improperl di pen ed componen
D B) Wrong label
C) Improper par i ioning of prod c ion area
D) Componen are kep in igh l - ealed
con ainer

Con en niformi i o be performed for all


able ho e ac i e ingredien are:

A A) 50mg or le
B) 100mg or le
C) 50mg or more
D) None of he abo e

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Which of he follo ing i no a QC f nc ion?

A) In-proce anal i
D
B) In pec ion of con ainer
C) Labeling and packaging ma erial
D) In en or con rol

To al q ali mean :

A) Prod c ion i re pon ible for q ali


C B) Q ali combine ric adherence o
andard
C) Q ali i e er bod ' b ine
D) All of he abo e

The pre ence of a co on fiber in a liq id


prepara ion i con idered a a/an:

C A) In ernal defec
B) Cri ical defec
C) Oc lar defec
D) Variable defec

Ma erial o be ampled incl de he follo ing,


e cep :

C A) In ermedia e prod c
B) Ra ma erial
C) Record
D) Final prod c

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An anal ho de ermine he reng h, po enc


and percen age p ri of a dr g or
pharmace ical prod c i
performing:

C A) Special me hod
B) Iden ifica ion e
C) Pharmace ical a a ing
D) Pharmacopoeial e

The chemical fac or ed in calc la ion of percen


p ri of a b ance in ol me ric anal i :
A) mEq eigh
D
B) Molari
C) Ti er
D) A and C

The in r men ed in mea ring he op ical


ac i i of a ample:

A A) Polarime er
B) Refrac ome er
C) Spec rome er
D) Flame pho ome er

In A eo ropic me hod for a er anal i , he


ol en ha can be ed i /are:
A) Wa er
D
B) Tol ene
C) X lene
D) B and C

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Ad orp ion indica or are ed in:

A) Comple ime r
C
B) Acidime r
C) Vol me ric precipi a ion
D) Alkalime r

The moi re con en of a dr g ma be:

A) Wa er of h dra ion
D
B) Wa er in he ab orbed form
C) Wa er of em l ion
D) A and B

The indica or ed in permangana e i ra ion:

A) Me h l orange
C
B) Phenolph halein
C) Permangana e ol ion
D) Me h l red

The indica or for EDTA direc i ra ion of calci m


carbona e:

B A) Th mol bl e
B) H dro naph hol bl e
C) Me h l red
D) Me h lene bl e

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