Quality Control (Blue)

C

A buret with a glass stopcock can be used for:

A. Alcohols C. Acids

B. Bases D. Salts

D

The operation speed for paddle in a dissolution apparatus is:

A.150 rpm C.100 rpm

B. 200 rpm D. 50 rpm

D

Radiant energy refers to:

A. Visible C. UV

B. IR D. All of the above

D

High pressure liquid chromatography method of analysis is more advantageous than the other

column chromatography as to:

A. Ease to operate C. More precise

B. Greater speed D. All of the above

A

Content uniformity test is to be performed for all tablet products whose active ingredient is:

A. 50 mg or smaller C. 130-324 mg

B. 324 mg or more D. 130 mg or less

B

The statement of expiration date assures the patient:

A. Absence of toxicity C. Complete absorption of drug

B. Full therapeutic efficacy D. Absence of interaction

B

A factor obtained by taking the ratio of the actual normality to the theoretical normality is:

A. Titer C. Flame photometer

B. Normality factor D. Polarimeter

D

To measure the optical activity of a sample, the instrument used is:

A. Spectrometer C. Flame photometer

B. Refractometer D. Polarimeter

C

In phenol content determination of a volatile oil, the layer in the graduated neck of the cassia

flask read 2.7 ml obtained from a sample of 10 ml of the oil after treatment of KOH. The %

phenol is:

A. 69.8 C. 73.0

B. 27.0 D. 7.30

B

Using the Karl Fischer method, determine the moisture content of a sample of raw material

where a 63 mg sample consumed 0.75 ml of titrant. Water equivalence factor is 1.10.

A. 1.8% C. 2.10%

B. 1.3% D. 0.74%

D

During shipment of the finished product to the wholesale or retail outlets, the responsible person

should ensure:

A. Product identification C. Segregation of different types

B. No damage, spillage or breakage D. All of the above

C

To find the mEq factor of an oxidizing agent is to divide the molecular weight by:

A. Valence C. No. of electrons gained (VDGEROA)

B. No. of electron lost D. Replaceable hydrogen

D

Lower control limit if mean is 10.5 ml and one standard deviation is 0.025.

A. 10.450 ml C. 10.575 ml

B. 10.420 ml D. 10.425 ml

C

Gas chromatography is utilized in the separation and identification of:

A. Amino acid C. Volatile liquids in a mixture

B. Alkaloids D. Blood components

C

The name of the originator of using silver nitrate as the titrant and potassium chromate as the

indicator in volumetric precipitation of chloride.

A. Volhard C. Mohr

B. Beer D. Fajan

B

Reassay date of thiamine Hcl if tested in December 1992.

A. 6/93 C. 12/94

B. 12/93 D. 6/94

A

Find the acid number of a raw material a mole weighing 1.230 g which required 30 ml of

0.1100 N NaOH to bring out the end point using alcoholic KOH in the titration.

A. 150.54 mg/g C. 109.18 mg/g

B. 157.72 mg/g D. 124.41 mg/g

B

A critical defect that would stop the packaging operation is:

A. Misaligned label C. Smeared label

B. Wrong label D. Inverted label

C

An instrument use to measure the durability of tablets to shipping/transportation against shock

and abrasion.

A. Metal detector C. Friabilator

B. Top loading balance D. Colorimeter

A

Methods of microbial assay of antibiotics:

A. Turbidimetric C. Both A and B

B. Cylinder plate D. None of the above

B

Retention or preservation of samples and records of all pharmaceutical products should be

monitored for signs of deterioration. The length of time they should be stored is:

A. 2 years after date of expiration C. 2 years

B. 1 year after date of expiration D. 3 years

D

Potentiometry finds application in:

A. Biological assay C. Qualitative analysis

B. Identification test D. pH determination

A

In the assay of sulfonamides, the method used is:

A. Diazotization C. Gravimetric

B. Acid-base titration D. Volumetric

B

A term in compleximetry used to indicate a determination of a metal in the presence of another

metal.

A. Linking C. Complexing

B. Masking D. Redox

D

cGMP is:

A. An agency created by RA 3720

B. Also known as Food, Drug and Cosmetic Act

C. Both A and B are correct

D. Both A and B are incorrect

D

The sampling and examination of all raw materials received by the factory is a function of the:

A. Documentation C. Material inspection

B. Biological testing laboratory D. Analytical laboratory

B

The indicator for EDTA direct titration against CaCO3 is:

A. Methyl red C. Methylene blue

B. Hydroxynaphthol blue D. Thymol blue

C

Safety or toxicity for infusion plastic sets is conducted using:

A. Dogs C. White mice

B. Food ingestion D. Rabbits

A

Chemical analysis which determines the amount of percentage content in which the component

of a substance is present:

A. Quantitative C. Qualitative

B. Proximate D. Ultimate

C

The addition of overage is justified when:

A. The clinical studies show that the overage is safe therapeutically

B. The unstable active ingredients cannot be possibly standardized

C. Both statements are correct

D. Both statements are incorrect

C

The period of stability of a preparation is the time from the date of manufacture of the

formulation until its chemical or biological activity is not less than ___ of the labeled potency.

A. 99% C. 90%

B. 93% D. 95%

A

Adsorbents used in TLC:

A. Silica gel and aluminum oxide C. Silica gel

B. Aluminum oxide D. Kieselguhr

C

Content uniformity test is conducted in:

A. 5 tablets C. 10 tablets

B. 20 tablets D. 15 tablets

B

The most effective manner to clean glass apparatus is:

A. Soaking in detergent C. Rinsing with alcohol

B. Treatment with chromic acid D. Rinsing with nitric acid

C

Ferrous sulfate is:

A. Agent that loses electron C. Reducing agent

B. An oxidizing agent D. Both A and C

A

A test which is determined by selecting not less than 30 tablets from each production batch and

assaying 10 tablets individually as directed in the assay of the individual compedial monograph.

A. Content uniformity C. Disintegration test

B. Weight variation D. Dissolution test

A

These are instruments under spectrometric methods which operate based on the absorption or

emission of electromagnetic radiation as a result of it interation with matter, EXCEPT:

A. Potentiometer C. X-ray

B. NMR D. IR

A

The ash content of an organic compound is an impurity of:

A. Inorganic matter C. Gas

B. Carbon D. Volatile oil

A

Type of Q.C equipment used for measuring the absorbance of substances between regions

380- 780 nm.

A. UV_VIS spectrophotometer C. Mass spectrophotometer

B. Infrared spectrophotometer D. Colorimeter

A

Type of titration used in volumetric analysis:

A. Neutralization C. Direct

B. Residual D. Both B and C

A

The choice method of determining the alcohol content of pharmaceutical preparation:

A. Specific gravity C. Fractional distillation

B. Percolation D. Cryoscopic

C

The gram molecular weight of sulfuric acid is 98. A solution containing 49 g/L of solution is:

A. 0.2 M C. 1 N

B. 0.5 N D. 1 M

B

USP steroid identification test:

A. Gravimetric C. Fluoroscopic

B. Spectrophotometric D. Chromatographic

C

Which of the following are principles of chromatographic separation?

I. Adsorption III. Ion-exchange

II. Partition IV. Molecular exclusion

A. I and II C. I, II, III and IV

B. I, II and III D. None of the above

B

Titer is an expression of concentration in terms of:

A. g/L C. g of solute/100 ml

B. mg/L D. g or mg/ml

A

Titrating an alkaline sample with an acid standard solution is known as:

A. Direct alkalimetry C. Precipitation method

B. Gravimetric analysis D. Indirect alkalimetric

B

Retention or preservation of samples and records of all pharmaceutical products should be

monitored for sign of deterioration. The length of time they should be stored is:

A. 2 years

B. 1 year after the expiry date of the product

C. 3 years

D. 2 years after the expiry date

B

LAL reagent is used to:

A. Measure pH of solution C. Prevent the oxidation of parenteral prep

B. Test the presence of pyrogens D. Acts as preservative for pharmaceutical

C

Control chart limit which alerts the operator to closely monitor the process:

A. Warning limit C. Acceptable limit

B. Action limit D. Any of these

D

In-process inspection tests to be perform during the filling of parenteral products:

A. Viscosity

B. Light inspection for clarity of solution

C. Fill volume

D. Light inspection and fill volume

D

USP limit for tablet content uniformity:

A. 90-110% C. 95-110%

B. 90-100% D. 85-115%

D

Analysis function would include:

A. Shelf-life studies C. Raw material control

B. In-process control D. All of these

A

In the SQC, the control chart prepared based on the number of fraction defective is called:

A. Attribute chart C. Beer's plot

B. Bar chart D. Variable chart

B

The number of linear openings per square inch is known as:

A. Sieve C. Both A and B

B. Mesh D. None of these

B

Test used to determine the strength of tablets includes:

A. Content uniformity C. Weight variation

B. Hardness D. Both A and B

B

Which of the given is the least used as sampled materials?

A. Final product C. Intermediate product

B. Records D. Raw materials

D

The presence of cotton fiber in a liquid preparation is considered a/an:

A. Critical defect C. Internal defect

B. Variable defect D. Ocular defect

D

A special residual method in acidimetry intended for the determination of nitrogen content in

organic compounds.

A. Karl Fischer method C. Volhard method

B. Back titration D. Kjeldahl method

A

Assay of 250 mL solution of Dopamine 200 mg injection resulted in the following data. Based on

these, determine the amount of Dopamine in 100 mL solution:

Sample volume 5.0 mL

Solution volume 250.0 mL

Absorbance sample 38259

Absorbance standard 20163

A. 0.04 mg/100mL C. 3.8 mg/100mL

B. 4.5 mg/100mL D. 4.5 mg/100mL

B

The disintegration constant of a radioisotope is 0.0502 day

1

. Calculate the half life of the

radioisotope.

A. 11 days C. 15 days

B. 13 days D. 21 days

C

Determine the distance traveled by the solute, if its Rf value is 0.688 and the solvent travels

8.0 cm. the sample weight is 1.02 mg.

A. 11.6 cm C. 5.5 cm

B. 11.8 cm D. 0.70 cm

B

One mole of dichromate ions gains a total of ___ electrons when converted to chromous ion.

A. 3 C. 10

B. 6 D. None of the above

B

Koetsdorfer number is a synonym for:

A. Ester value C. Iodine value

B. Saponification value D. Acetate value

D

The chemical constant used in the analysis of fats and oils are:

A. Iodine value C. Acid value

B. Saponication value D. All of the above

A

Water content of raw materials is determined by quality control equipment, such as:

I. Ohaus moisture balance III. pH meter

II. Karl Fischer Tritrimetry IV. Vacuum oven

A. I, II and IV C. I, II and III

B. II, III and IV D. I, II, III and IV

C

The primary standard used to standardize Karl fisher reagent is:

A. Anhydrous sodium carbonate C. Sodium tartrate

B. Potassium bipthalate D. Sodium oxalate

D

Plastic containers for ophthalmic or parenteral preparations are sterilized by:

A. Microwave C. Soaking in formalin

B. Autoclaving D. Ethylene oxide

D

A sample is:

A. Is taken from a population

B. It should represent the whole batch from where it is taken

C. Is a finite number of objects selected from a population

D. All of the above

B

Instrument to determine the tightness of a cap is:

A. Crimper C. Resister

B. Torque tester D. pH meter

D

Its primary objective is to monitor all features of a product.

A. SOP C. Stability testing

B. Sampling D. IPQC

D

It has a high degree of purity and is used in direct standardization purposes:

A. Technical grade C. Primary standard

B. CP grade D. Any of the above

B

he primary standard used for standardization of Ce(SO

4)2 in cerimetric method of analysis is:

A. K2Cr2O7 C. KmnO4

B. As2O3 D. H2C2

B

In paper partition chromatography, what is the Rf value of a compound if the solute travels 3.1

cm and the solvent moves 4.3 cm after 5 minutes?

A. 3.605 C. 13.33

B. 0.721 D. 1.387

B

A sampling inspection in which decision is made to accept or not to accept an item:

A. Rejection number C. Acceptance number

B. Acceptance sampling D. Any of the above

D

Indicators used for acid-base titration, EXCEPT:

A. Methyl red C. Phenolphthalein

B. Methyl orange D. Ferric alum

A

Sample size of bottles to check for cap tightness.

A. 10 C. 20

B. 30 D. 15

C

Quantitative analysis of morphine.

A. Ultimate analysis C. Ultimate assay

B. Proximate assay D. Proximate analysis

C

What is the normality of sulfuric acid containing 73.5 g/500 mL of solution?

A. 2.0 N C. 3.0 N

B. 2.5 N D. 1.0 N

D

Three months of acceptable data at 37-40

0

C/75% RH can be extrapolated to ___ year/s

expiry date.

A. 1 C. 4

B. 5 D. 2

D

The periodic examination on the quality of inventories is a function of:

A. Quality coordination office C. Analytical lab

B. Biological testing lab D. Material inspection section

B

The spotting agnt for amino acids in paper chromatography is:

A. Potassium chromate C. Silver nitrate

B. Ninhydrin D. Iodine

D

Negligible ash in a pharmaceutical preparation is:

A. 200 mg C. 500 mg

B. 1000 mg D. 500 mcg

A

The reassay date of raw material is based on their:

A. Stability C. Quantity purchased

B. Price D. None of the above

D

Quality must be built into the product during:

A. Research C. Production

B. Development D. All of the above

B

Recommended indicator in the assay of alkaloids:

A. Phenolphthalein C. Methyl orange

B. Methyl red D. Litmus paper

C

The titrant in non-aqueous alkalimetry is:

A. Ammonium hydroxide C. Sodium methoxide

B. Perchloric acid D. Sodium hydroxide

A

Two substances reacting upon reaching the end point must have the same:

A. Number of equivalents C. Normality

B. Volume D. Weight

A

In radiopharmacy, REM means

A. Roentgen equivalent man C. Radiation per minute

B. Radiation per mill second D. Roentgen exposure per minute

D

One of the laws in spectrophotometry:

A. Law of mass action C. Newton's law

B. Boyle's law D. Beer's law

B

Substances that have the power of rotating the plane polarized light are said to be.

A. Light sensitive C. Active constituents

B. Optically active D. Dextrorotatory

A

Nephelometry is based on the measurement of light that is:

A. Reflected C. Absorbed

B. Transmitted D. Adsorbed

B

The process of determining the volume of standard solution required to react with a known

amount of substance being assayed.

A. Neutralization C. Oxidation

B. Titration D. Hydrolysis

A

Color of phenolphthalein in caustic potash.

A. Pink C. Colorless

B. Yellow D. Orange

A

The potency of drug component is commonly determined by:

A. HPLC C. GC

B. Titrimetric method D. Spectrophotometric method

C

The index of refraction of a volatile oil is determined by using:

A. Pectrophotometer C. Refractometer

B. Pycnometer D. Polarimeter

A

A type of sampling which is permitted if the first one falls:

A. Double C. Both A and B

B. Single D. None of the above

A

What is preferred for standardization of permanganate?

A. Sodium oxalate C. Hydrogen peroxide

B. Sodium carbonate D. Sodium nitrate

D

Instability will be accelerated by:

A. Temperature C. Light

B. Heat D. All of the above

C

Assay of NaCl in table salt by precipitation as AgCl, filtration, drying, and weighing the residue

is classified as:

A. Precipitimetry C. Gravimetric analysis

B. Volhard method D. Residual precipitimetry

A

An analyst who determines the strength, potency, and percentage purity of a drug or

pharmaceutical product is performing:

A. Pharmaceutical assaying C. Pharmacopeial test

B. Identification test D. Special test