Exam Details
| Subject | advanced pharmaceutical analysis | |
| Paper | ||
| Exam / Course | mca | |
| Department | ||
| Organization | Gujarat Technological University | |
| Position | ||
| Exam Date | January, 2019 | |
| City, State | gujarat, ahmedabad |
Question Paper
Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM SEMESTER EXAMINATION -WINTER 2018
Subject Code: MPA102T Date: 03/01/2019
Subject Name: Advanced Pharmaceutical Analysis
Time :10:30 AM TO 01:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make Suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1
Explain Selection of batches, sampling frequency, specifications and storage condition with respect to stability testing protocols.
06
Give a short note on handling of degradation product.
05
Describe in brief the procedure to study stability of the natural products.
05
Q.2
Give a note on photo stability testing guidelines.
06
Discuss various Potential Sources of Elemental Impurities.
05
Give applications of Immunoassay in relation to quantification.
05
Q.3
Why it is important to control residual solvent? Classify residual solvents in detail along with their limits and reporting levels.
06
Discuss HPTLC/HPLC finger printing interactions.
05
Describe method for separation of bound and unbound drug in Immunoassays.
05
Q.4
What is gene regulation? Explain principle and procedures of PCR studies for gene regulation.
06
Give effects of impurities in new drug products in terms of degradation.
05
Write biological tests and assays of Rabies Vaccine.
05
Q.5
Define immunoassay. Explain basic principle of IA and production of antibodies.
06
Discuss ICH guidelines laid down for stability studies for biological products.
05
What is oxytocin? Give principle and procedure for the bioassay of Oxytocin.
05
Q. 6
Discuss the regulatory requirements and protocols for phyto-pharmaceuticals
06
Classify impurities in API. And its effects on stability of sample.
05
Describe various factors which affect the stability of samples.
05
Q.7
Define impurity and give detail notes of quantification of impurities as per ICH guideline.
06
Give Safety Assessment of Elemental Impurities for Oral, Parenteral and Inhalation Routes of Administration.
05
Discuss in detail shelf life calculation and stability zones.
05
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM SEMESTER EXAMINATION -WINTER 2018
Subject Code: MPA102T Date: 03/01/2019
Subject Name: Advanced Pharmaceutical Analysis
Time :10:30 AM TO 01:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make Suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1
Explain Selection of batches, sampling frequency, specifications and storage condition with respect to stability testing protocols.
06
Give a short note on handling of degradation product.
05
Describe in brief the procedure to study stability of the natural products.
05
Q.2
Give a note on photo stability testing guidelines.
06
Discuss various Potential Sources of Elemental Impurities.
05
Give applications of Immunoassay in relation to quantification.
05
Q.3
Why it is important to control residual solvent? Classify residual solvents in detail along with their limits and reporting levels.
06
Discuss HPTLC/HPLC finger printing interactions.
05
Describe method for separation of bound and unbound drug in Immunoassays.
05
Q.4
What is gene regulation? Explain principle and procedures of PCR studies for gene regulation.
06
Give effects of impurities in new drug products in terms of degradation.
05
Write biological tests and assays of Rabies Vaccine.
05
Q.5
Define immunoassay. Explain basic principle of IA and production of antibodies.
06
Discuss ICH guidelines laid down for stability studies for biological products.
05
What is oxytocin? Give principle and procedure for the bioassay of Oxytocin.
05
Q. 6
Discuss the regulatory requirements and protocols for phyto-pharmaceuticals
06
Classify impurities in API. And its effects on stability of sample.
05
Describe various factors which affect the stability of samples.
05
Q.7
Define impurity and give detail notes of quantification of impurities as per ICH guideline.
06
Give Safety Assessment of Elemental Impurities for Oral, Parenteral and Inhalation Routes of Administration.
05
Discuss in detail shelf life calculation and stability zones.
05
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- advanced medicinal chemistry
- advanced networking (an)
- advanced organic chemistry -i
- advanced pharmaceutical analysis
- advanced pharmacognosy-1
- advanced python
- android programming
- artificial intelligence (ai)
- basic computer science-1(applications of data structures and applications of sql)
- basic computer science-2(applications of operating systems and applications of systems software)
- basic computer science-3(computer networking)
- basic computer science-4(software engineering)
- basic mathematics
- basic statistics
- big data analytics (bda)
- big data tools (bdt)
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- cloud computing (cc)
- communications skills (cs)
- computer aided drug delivery system
- computer graphics (cg)
- computer-oriented numerical methods (conm)
- cyber security & forensics (csf)
- data analytics with r
- data mining
- data structures (ds)
- data visualization (dv)
- data warehousing
- data warehousing & data mining
- database administration
- database management system (dbms)
- design & analysis of algorithms(daa)
- digital technology trends ( dtt)
- discrete mathematics for computer science (dmcs)
- distributed computing (dc1)
- drug delivery system
- dynamic html
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- language processing (lp)
- machine learning (ml)
- management information systems (mis)
- mobile computing
- molecular pharmaceutics(nano tech and targeted dds)
- network security
- object-oriented programming concepts & programmingoocp)
- object-oriented unified modelling
- operating systems
- operation research
- operations research (or)
- pharmaceutical validation
- phytochemistry
- procedure programming in sql
- programming skills-i (ps-i-fop)
- programming skills-ii (ps-oocp)
- programming with c++
- programming with java
- programming with linux, apache,mysql, and php (lamp)
- programming with python
- search engine techniques (set)
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- software engineering
- software lab (dbms: sql & pl/sql)
- software project in c (sp-c)
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