QA AND QC PART2 IJNIP

C

The following methods can be used for identification of substances, EXCEPT:

A. HPLC

b. IR Spectroscopy

C. Titrimetry

d. Color reaction test

A

An analyst who determines the strength, potency and percentage purity of an active ingredient is performing:

a. Pharmaceutical assaying

b. Pharmacopeial analysis

c. Identification Testing

d. NOTA

D

The bioassay for measuring the potency of Heparin Sodium is based on the use of the plasma of:

a. rat

b. cat

c. dog

d. sheep

C

The following may be useful when performing microbiological assay of antibiotics, EXCEPT:

A. Test Tube inoculation

b. Paper disc

c. Staining method

D. Cylinder plate

B

This test is done to determine the amount of impurities in a raw material

a. Solubility test

b. Limit test

c. Loss on drying

d. Loss on ignition

C

It is the degradation products, reagents, catalysts, ligands and heavy metals

A. Gross impurities

B. Biological impurities

C. Chemical impurities

A

It is the dirt or insoluble matter

A. Gross impurities

B. Biological impurities

C. Chemical impurities

D

Which of The following laboratory apparatuses may be employed in the determination of specific gravity?

a. Hydrometer

b. Pycnometer

C. Mohr-Westphal Balance

d. All of the above

Beissler

Aside from the pycnometer , what is the other instrument used for specific gravity?

D

The specific gravity of alcohol is measured using______

a. Hydrometer

b. Pycnometer

C. Mohr-Westphal Balance

d. All of the above

A

Which physical property of a drug molecule is represented by the formula: n = sin i/sin r

a. Refractive index

b. Circular dichroism

c. Optical rotation

d. Optical rotatory dispersion

D

Which of the following RMQC Tests will help determine the amount of volatile matter in a sample?

a. Boiling Point*

b. Melting Point

c. Water Determination

d. Loss on Drying

C

What is the instrument use for measuring specific gravity?

A. Polarimeter

B. Thiele tube or distillation

C. Pycnometer

D. Abbe refractometer

D

What is the instrument use for measuring refractive index?

A. Polarimeter

B. Thiele tube or distillation

C. Pycnometer

D. Abbe refractometer

A

What is the instrument use for measuring optical rotation?

A. Polarimeter

B. UV-vis spectrometer

C. Pycnometer

D. Abbe refractometer

C

The specific method of water determination official in the

USP/NF, EXCEPT:

a. Titrimetric

b. Gravimetric

c. Dew Point

D. Azeotropic

C

What is the most common method I of Titrimetric?

A. Method Ia

B. Method Ib

C. Method Ic

A

Calculate the water content of the sample of Lidocaine HCl weighing 0.1564 g, which consumed 2.094 mL of Karl Fischer Reagent. The water equivalence factor of the KFR used was 4.6485.

a. 6.22%

b. 34.7%

c. 7.05%

d. 62%

B

Board question: What is the liquid use in azeotropic method?

A. Water

B. Toluene

C. Iodine

D. Alcohol

110-120C

What is the sample drying temp in gravimetric for inorganic?

105C

What is the sample drying temp in gravimetric for organic?

B

What is the method use for measuring light transmission?

A. Polarimeter

B. UV-vis spectrometer

C. Pycnometer

D. Abbe refractometer

B

In USP 30, which type ofII glass is subjected to Water Attack Test?

a. Type I

b. Type II

c. Type III

d. NP

A

Distinguishes type I and II from type III

A. Surface glass test

B.  Glass grains test

C. Surface etching test

C

Distinguishes type I from type II

A. Surface glass test

B.  Glass grains test

C. Surface etching test

B

Distinguishes type I from Type II and III

A. Surface glass test

B.  Glass grains test

C. Surface etching test

B

In the assay for elastomeric closures using direct contact and elution, what is the test organism used?

a. Guinea pig

b. Tissue culture

c. Mice

d. Rabbit

Analytical sieving

BOARD: What is the official method for particle size distribution?

Andreasen apparatus

What is the instrument use for sedimentation rate?

D

The following are methods of analytical sieving, EXCEPT:

a. Dry sieving

B. Air jet sieving

C. Sonic sifter sieving

D None of the above

D

B

The constant 3D angle  assumed by a cone like pile of material.

A. Carr’s index

B. Angle of repose

C. Flow through an orifice

D. Shear cell

A

Measures of powder compressibility; calculated using bulk  & tapped density

A. Carr’s index or Hausner ratio

B. Angle of repose

C. Flow through an orifice

D. Shear cell

A

Determine the flow property of a sample of Cetepime powder which has an untapped volume of 99.0 mL and tapped volume of 89.2 mL.

A. excellent

b. Good

c. Fair

d. Passable

B

It measures tablets resistance to mechanical shocks

A. Tablet thickness

B. Tablet hardness

C. Tablet weight variation

D

Tablet hardness tester which is based on compressing tablets between two jaws via a spring gauge and screw

a. Erweka

b. Pfizer

c. Schleuniger

d. Stokes-Monsanto

e. Strong Cobb

A

This is the acceptable tablet hardness range for chewable tablets:

a. 2 to 3 kg

b. 4 to 10 kg

c. 7 to 10 kg

d. 10 to 20 kg

A

Given a standard tablet thickness of 0.47 cm, what should be the acceptable range?

a. 0.4465 - 0.4935 cm

b. 0.4348 - 0.5050 cm

c. 0.4230 - 0.5170 cm

d. 0.3525 - 0.5875 cm

B

90 to 110 %

What is the usual acceptance criteria when conducting assay?

C

Friability testing is done using a Roche friabilator that must be set To ensure:

a. 10 falls of tablets

b. 100 rpm

c. 100 falls of tablets

d. Either A or B

B

A state in which any residue of the unit, except fragments of insoluble coating or capsule shell, remaining on the screen of the test apparatus is a soft mass having no palpably firm core

a. Partial disintegration

b. Complete disintegration

c. Partial dissolution

d. Complete dissolution

C

Disintegration test is done at this temperature

a. 36.5 - 37.5 °C

b. 36-38 °C

c. 35 - 39 °C

d. 34 - 40 °C

B

Dissolution is the tablet atribute correlated with the biological availability of the active ingredient. Which of the following metallic drive shaft accessory is the paddle?

a. Apparatus 1

b. Apparatus 2

c. Apparatus 3

d. Apparatus 4

e. Apparatus 5

C

Weight variation is to be performed for uncoated tablets whose active ingredients are:

a. < 25mg

b. < 50mg

c. ≥ 25mg

d. ≥ 50mg

C

Weight variation is to be performed for uncoated tablets whose active ingredients are:

a. < 25mg

b. < 50mg

c. ≥ 25mg

d. ≥ 50mg

B

The following pairs are correct, EXCEPT:

A. Weight variation (n = 20 units)

B. Content uniformity (n = 20 units)

c. Friability > 650 mg (n = 10 units)

d. Disintegration (n = 6 units)

e. Dissolution (n = 6 units)

C

The following are FPQC Tests for capsules, EXCEPT:

a. Dissolution

b. Disintegration

c. Friability

d. Weight variation

e. Content uniformity

D

This FPQC test determines the correctness of the net content of semisolid dosage forms as compared to the labeled content

a. Deliverable volume

b. Content uniformity

c. Weight variation

d. Minimum fill

A

Board: What is the instrument use to measure the viscosity of ointments?

A. Brookfield

B. Roche

C. Penetrometer

D. Andreasen

C

Board: What is the instrument use to measure the consistency of ointments?

A. Brookfield

B. Roche

C. Penetrometer

D. Andreasen

A

Provide assurance that oral liquids will, when Transferred from The original container, deliver The volume of dosage form that is declared on the label

a. Deliverable volume

b. Content uniformity

c. Weight variation

d. Minimum fill

Staphylococcus aureus and pseudomonas aeruginosa

What should be absent in microbial test of semi solid dosage forms?

Zeta potential

It is the repulsive forces between particles

A

Two different batches of amoxicillin 125 mg/5 mL suspensions were compared with the ff result is . Which is a better product based on sedimentation volume?

Batch 1: Total vol = 250 mL; settled vol = 189 mL

Batch 2: Total vol = 250 mL; Settled vol = 156 mL

a. Batch 1

b. Batch 2

c. Same

d. Cannot be determined

A

Which of the following test results corresponds to an emulsion of oil-in-water type?

a. pink filter paper with CoCl2

b. red globules against a Transparent background with amaranth

c. separation when diluted with water;

d. continuous fluorescence

D

Assay method that determines the presence of pyrogen in injectables

a. Rabbit test

b. LAL test

c. White mice test

d. A and B

C

A parenteral is declared pyrogenic if the Temperature rise in rabbits is

a. ‹ 1.4 °C in the total temp rise total of the 3 rabbits

b. 0.6°C temp rise in 1 rabbit

c. More than 3.3 °C in the Temp rise of 8 rabbits

d. NOTA

B

Sterility testing of pharmacopeial articles test for the presence of

a. Gram (+) and gram (-) organism

b. Aerobic and anaerobic organism

c. Both A & BA

d. NOTA

C

Dye used to determine incompletely sealed containers in Leakers Test:

a. Amaranth

b. Sudan red

c. Methylene blue

d. Crystal violet

A

It is the preferred method for observing sub-visible particles.

a. Method I

b. Method II

c. Method III

d. Method IV

Negative pressure

What is the pressure required in leakers test?