Exam Details
| Subject | sterile dosage forms | |
| Paper | ||
| Exam / Course | b. pharmacy | |
| Department | ||
| Organization | solapur university | |
| Position | ||
| Exam Date | October, 2018 | |
| City, State | andhra pradesh, solapur |
Question Paper
B.Pharm. (Semester VII) (CGPA) Examination, 2018
sterile Dosage forms
Day and Date Friday, 21-12-2018 Max. Marks 70
Time 10.30 a.m. to 1.30 p.m.
I. MCQ 15
Reduction of D-value by 90% is known as
Z-value F-value I.V. None of these
NDA is an application for
New drug Approved drug
Post market approved drug All of these
As per GMP for grade B and C at least per hour.
10 air changes 20 air changes
50 air changes 100 air changes
Hot DOP test is useful for the evaluation of
HEPA Temperature sensitivity
Blowers All of these
To evaluate the chemical resistance of glass, which of the following tests
are conducted
Powder glass Water attack test
Both a and b None of these
Which of the following co-solvents are used to increase the solubility of a
drug
Ethanol Sorbitol Glycerin All the above
Out of following applications which one is not related to a new drug
ANDA AADA NDA Both a and b
Mechanism of dry heat sterilization
Oxidation of proteins
Denaturation and coagulation of proteins
Alkylation of sulfhydryl group
Denaturation of DNA
The major obstacle for the ocular bioavailability is
Cornea Sclera Iris None of these
Seat
No. Set P
Set P
SLR-TV 43 *SLRTV43*
10) LVP containing bacteriostatic agent label should have warning.
Keep in dark place Store below 4°C temp.
Not for use in neonates Dilute before use
11) For reconstitution of dosage form which solvent is suitable
SWFI WFI
Bacteriostatic WFI RO water
12) To avoid leaching, rubber closures can be laminated with
PVC Silicon oil Teflon All the above
13) Which of the following test is performed on whole container
Powder glass Water attack test
Both a and b None of these
14) Which of the following strength of Dextrose Injection is isotonic in humans
2.5% w/v w/v w/v 0.9% w/v
15) When a needle damages the rubber closure of a parenteral container
causing fragments to fall into the container is known as
Coring Injectability Syringe ability Bevel
II. Answer any five 25
Give design of sterile dosage form facility.
Write a note on HVAC.
Discuss technology transfer.
How to detect leak and particulate matter in parenteral dosage forms
Discuss ocular bioavailability.
Discuss rubber as a parenteral packaging component.
III. Answer any three 30
Discuss different types of solvents used in parenteral with their specific
applications.
Give the essential characteristics of parenteral dosage forms.
Discuss different approaches of parenteral manufacturing.
Give the cleanliness classes and discuss HEPA with its validation
techniques.
sterile Dosage forms
Day and Date Friday, 21-12-2018 Max. Marks 70
Time 10.30 a.m. to 1.30 p.m.
I. MCQ 15
Reduction of D-value by 90% is known as
Z-value F-value I.V. None of these
NDA is an application for
New drug Approved drug
Post market approved drug All of these
As per GMP for grade B and C at least per hour.
10 air changes 20 air changes
50 air changes 100 air changes
Hot DOP test is useful for the evaluation of
HEPA Temperature sensitivity
Blowers All of these
To evaluate the chemical resistance of glass, which of the following tests
are conducted
Powder glass Water attack test
Both a and b None of these
Which of the following co-solvents are used to increase the solubility of a
drug
Ethanol Sorbitol Glycerin All the above
Out of following applications which one is not related to a new drug
ANDA AADA NDA Both a and b
Mechanism of dry heat sterilization
Oxidation of proteins
Denaturation and coagulation of proteins
Alkylation of sulfhydryl group
Denaturation of DNA
The major obstacle for the ocular bioavailability is
Cornea Sclera Iris None of these
Seat
No. Set P
Set P
SLR-TV 43 *SLRTV43*
10) LVP containing bacteriostatic agent label should have warning.
Keep in dark place Store below 4°C temp.
Not for use in neonates Dilute before use
11) For reconstitution of dosage form which solvent is suitable
SWFI WFI
Bacteriostatic WFI RO water
12) To avoid leaching, rubber closures can be laminated with
PVC Silicon oil Teflon All the above
13) Which of the following test is performed on whole container
Powder glass Water attack test
Both a and b None of these
14) Which of the following strength of Dextrose Injection is isotonic in humans
2.5% w/v w/v w/v 0.9% w/v
15) When a needle damages the rubber closure of a parenteral container
causing fragments to fall into the container is known as
Coring Injectability Syringe ability Bevel
II. Answer any five 25
Give design of sterile dosage form facility.
Write a note on HVAC.
Discuss technology transfer.
How to detect leak and particulate matter in parenteral dosage forms
Discuss ocular bioavailability.
Discuss rubber as a parenteral packaging component.
III. Answer any three 30
Discuss different types of solvents used in parenteral with their specific
applications.
Give the essential characteristics of parenteral dosage forms.
Discuss different approaches of parenteral manufacturing.
Give the cleanliness classes and discuss HEPA with its validation
techniques.
Other Question Papers
Subjects
- anatomy, physiology and health education – i
- anatomy, physiology and health education – ii
- biochemistry
- biochemistry – i
- biochemistry – ii
- biopharmaceutics
- biotechnology
- clinical pharmacology
- herbal technology
- human anatomy and physiology – i
- human anatomy and physiology – ii
- medicinal chemistry – i
- medicinal chemistry – ii
- medicinal chemistry – iv
- microbiology
- modern dispensing and hospital pharmacy
- novel drug delivery systems
- organic chemistry – i
- organic chemistry – ii
- organic chemistry – iii
- pathophysiology (new cbcs)
- pathophysiology and clinical biochemistry – i
- pathophysiology and clinical biochemistry – ii
- pharmaceutical analysis – i
- pharmaceutical analysis – ii
- pharmaceutical analysis – iv
- pharmaceutical analysis – v
- pharmaceutical analysis – vi
- pharmaceutical busines management
- pharmaceutical engineering
- pharmaceutical enginering
- pharmaceutical inorganic chemistry
- pharmaceutical jurisprudence
- pharmaceutical microbiology
- pharmaceutical organic chemistry – ii
- pharmaceutical organic chemistry –i
- pharmaceutics – i (new cbcs)
- pharmaceutics – i (old-cbcs pattern)
- pharmaceutics – ii
- pharmaceutics – iii
- pharmaceutics – iv
- pharmacognosy – i
- pharmacognosy – ii
- pharmacognosy – iii
- pharmacology – i (new) (cbcs pattern)
- pharmacology – ii
- pharmacology – ii (cgpa pattern)
- pharmacology – iv
- physical pharmaceutics – i
- physical pharmacy – i
- physical pharmacy – ii
- sterile dosage forms