#### 1. According to USP, sparingly soluble means the parts of solvent required for one part of solute is _____?

1. 10-30

2. 30-100

3. 100-1000

4. More than 1000

Right answer is (2)

#### 2. Which of the following is not used as diluents _____?

1. Lactose

2. MCC

3. Calcium carbonate

4. PVP

Right answer is (4)

#### 3. How much concentration of Benzalkonium chloride is used as preservative in eye drop _____?

1. 1.00% w/v

2. 0.10% w/v

3. 0.01% w/v

4. 0.05% w/v

Right answer is (3)

#### 4. What are the critical parts of granulation in FBP _____?

1. Atomizing air pressure

2. Air flow (fluidization)

3. Spray rate

4. All of the above

Right answer is (4)

#### 5. Commonly a granule size fall in ______?

1. 0.1-0.2 mm

2. 0.2-4.0 mm

3. 0.4-0.8 mm

4. >1.0 mm

Right answer is (2)

#### 6. Aerosil addition at wet granulation ____?

1. Increase the hardness

2. Decrease the hardness

3. None of the above

Right answer is (1)

#### 7. For Maize Starch paste preparation temperature should be _____?

1. More than 50°C

2. More than 60°C

3. More than 70°C

4. More than 90°C

Right answer is (4)

#### 8. Which of the following statement is right?

1. Crospovidone show better disintegration than SSG.

2. Highly porous granules show Low DT

3. Low porous granules show High DT

4. All of the above

Right answer is (4)

#### 9. ISO class 8 equivalent to _____?

1. Grade – A

2. Grade – B

3. Grade – C

4. Grade – D

Right answer is (4)

#### 10. Chromium coated punch used to _____?

1. Reduce punch erosion

2. Reduce dies erosion

3. Reduce tablet defect

4. None of the above

Right answer is (1)

#### 11. Basis of BCS classification system is _______?

1. Solubility

2. Permeability

3. All of the above

4. None of the above

Right answer is (3)

#### 12. Which BCS class shows High Solubility & Low Permeability ______?

1. BCS Class I

2. BCS Class II

3. BCS Class III

4. BCS Class IV

Right answer is (3)

#### 13. BCS based biowaivers discussed in ______?

1. ICH Q8 Guideline

2. ICH Q9 Guideline

3. ICH M8 Guideline

4. ICH M9 Guideline

Right answer is (4)

#### 14. A drug substance is considered highly soluble when the highest strength is soluble in _____?

1. 200 ml

2. 250 ml

3. 300 ml

4. 500 ml

Right answer is (2)

#### 15. If LogP value is more, compound is ________?

1. Hydrophilic

2. Hydrophobic

3. Neutral

4. None of the above

Right answer is (2)

#### 16. A drug substance is considered to be highly permeable when the systemic bioavailability is _____?

1. 80% or more

2. 85% or more

3. 90% or more

4. 100% or more

Right answer is (2)

#### 17. Levodopa fall in BCS class _____?

1. Class I

2. Class II

3. Class III

4. Class IV

Right answer is (1)

#### 18. Rabeprazole Na fall in BCS class _____?

1. Class I

2. Class II

3. Class III

4. Class IV

Right answer is (3)

#### 19. Gabapentin fall in BCS class _____?

1. Class I

2. Class II

3. Class III

4. Class IV

Right answer is (3)

#### 20. Etoricoxib fall in BCS class _____?

1. Class I

2. Class II

3. Class III

4. Class IV

Right answer is (2)

#### 21. Higher the HLB value of surfactant, more __________ it is.

1. Hydrophilic

2. Lipophilic

3. Amphoteric

4. None of above

Right answer is (1)

#### 22. Wetting agent has …………… HLB value.

1. 1 to 3

2. 3 to 6

3. 7 to 9

4. 8 to 18

Right answer is (3)

#### 23. Carr’s compressibility index gives an idea about ____.

1. Flow property of powders

2. Cohesiveness of powders

3. Both

4. None

Right answer is (3)

#### 24. What is the primary focus of Phase 3 Clinical testing?

1. How to manage costs.

2. The collection and analysis of highly specific efficacy end-point data

3. The optimal range of effective dosage.

4. The analysis of data results from the small-subset target population

Right answer is (2)

#### 25. Carcinogenicity and Genotoxicity study is a …… aspect of ICH guidelines.

1. Safety guidelines

2. Efficiency guidelines

3. QSEM guidelines

4. All of these

Right answer is (1)

#### 26. Pharmacovigilance is a part of _____.

1. ICH E1 guidelines

2. ICH E3 guidelines

3. ICH E2 guidelines

4. ICH E2 (A-F) guidelines

Right answer is (4)

#### 27. One of the following ingredients improves the flow property of granules is _____?

1. Lubricant

2. Emollient

3. Glidant

4. Surfactant

Right answer is (3)

#### 28. pH of the solution calculated by ______?

1. Henry’s law

2. Charle’s law

3. Dalton’s law

4. Henderson-Hasselbalch equation

Right answer is (4)

#### 29. Hausner ratio is _______

1. Bulk density/ Tapped density

2. Tapped density/ Bulk density

3. Bulk volume/ Void volume

4. Void volume/ Bulk volume

Right answer is (2)

#### 30. Which of the following tablet are formulated to prevent drug release in stomach ______?

1. Film coated tablet

2. Sugar coated tablet

3. Enteric coated tablet

4. Sustained release tablet

Right answer is (3)

#### 31. For sugar coated tablet, specified disintegration time is _____?

1. 10 minutes

2. 15 minutes

3. 30 minutes

4. 60 minutes

Right answer is (4)

#### 32. Particle size of Microcrystalline Cellulose (PH 102) is ______?

1. 10 µ

2. 50 µ

3. 100 µ

4. 200 µ

Right answer is (3)

#### 33. What is the Sieve Size (microns) of Sieve no. 40 _____?

1. 200 µ

2. 400 µ

3. 425 µ

4. 500 µ

Right answer is (3)

#### 34. Friability limit for most tablets ______?

1. NMT 0.5%

2. NMT 0.8%

3. NMT 1.0%

4. NMT 2.0%

Right answer is (3)

#### 35. For content uniformity maximum allowed acceptance value L1 is _______?

1. 5

2. 10

3. 15

4. 20

Right answer is (3)

#### 36. Minimum sampling point for Blend Uniformity test _____?

1. 3

2. 5

3. 10

4. 20

Right answer is (3)

#### 37. Water content of gelatin shell usually between _____?

1. 5% and 10%

2. 13% and 16%

3. 15% and 20%

4. 20% and 25%

Right answer is (2)

#### 38. USP Apparatus 2 is ______?

1. Paddles

2. Basket

3. Reciprocating cylinder

4. Flow through cell

Right answer is (1)

#### 39. Disintegration testing is discussed in USP general chapter ______?

1. 701

2. 711

3. 1092

4. 1216

Right answer is (1)

#### 40. Weight variation is performed by weigh ______?

1. 10 sample

2. 20 sample

3. 30 sample

4. 40 sample

Right answer is (2)

#### 41. Which of the following is preservative ______?

1. Benzyl alcohol

2. Methyl paraben

3. Chlorocresol

4. All of the above

Right answer is (4)

#### 42. When a drug substance is considered highly permeable?

1. If the extent of absorption is more than 90%

2. If the extent of absorption is more than 85%

3. If the extent of absorption is more than 75%

4. Both a & b

Right answer is (1)

#### 43. What is the temperature of media during disintegration testing?

1. 37°C±1°C

2. 37°C±0.5°C

3. 37°C±2°C

4. 37°C±0.1°C

Right answer is (2)

#### 44. How many lots of API should be used for manufacturing of Exhibit batches?

1. One

2. Two

3. Three

4. Four

Right answer is (2)

#### 45. How many exhibit batches are required to manufacture for US-FDA submission?

1. 01 Batch

2. 02 Batches

3. 03 Batches

4. 04 Batches

Right answer is (3)

#### 46. For content uniformity maximum allowed acceptance value L2 is ____?

1. 10

2. 15

3. 20

4. 25

Right answer is (4)

#### 47. Which parameter can be measured by AccuPyc Gas Pycnometer?

1. Tablet length

2. Tablet hardness

3. Tablet thickness

4. Tablet volume

Right answer is (4)

#### 48. State change from solid to gas without going into liquid phase is known as?

1. Melting

2. Evaporation

3. Sublimation

4. Freeze drying

Right Answer is (3)

#### 49. The insertion of a solvent molecule into the crystal lattice of solid is called?

1. Substrate

2. Hydrate

3. Solvate

4. Both b & c

Right Answer is (4)

#### 50. Effervescent tablets release which gas during they come in contact with water?

1. Carbon Dioxide

2. Sulfur Dioxide

3. Nitrous Oxide

4. None of the above

Right Answer is (1)

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