pharma analysis _ pharma tutor

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YOU ARE HERE Pharma Analysis Pharma Analysis Pharmaceutical Analysis INTRODUCTION Pharmaceutical analysis is a branch of practical chemistry that involves a series of process for identification, determination, quantification and purification of a substance, separation of the components of a solution or mixture, or determination of structure of chemical compounds. The substance may be a single compound or a mixture of compounds and it may be in any of the dosage form. The substance used as pharmaceuticals are animals, plants, micro organisms, minerals and various synthetic products. The sample to be analysed is called as analyse and on the basis of size of sample, they can be classified as macro(0.1 g or more), semi micro (0.01 g to 0.1 g), micro(0.001 g to 0.01 g), sub micro (0.0001 g to 0.001 g), ultramicro (below 10-4 g), trace analysis(100 to 10000 ppm). Among all, the semi micro analysis is widely used. TYPES There are main two types of chemical analysis. 1. Qualitative (identification) 2. Quantitative (estimation) 1. Qualitative analysis is performed to establish composition of natural/synthetic substances. These tests are performed to indicate whether the substance or compound is present in the sample or not. Various qualitative tests are detection of evolved gas, formation of precipitates, limit tests, colour change reactions, melting SUBSCRIBE WITH US Enter your email address: Do Not Forget to Verify (Click on Subscription link in your inbox) ACTIVE FORUM TOPICS NOTIFICATION MHT-CET-2012 | Government of TODAY'S POPULAR CONTENT Vacancy as DRUG INSPECTOR in Government of India, APSPSC - 56 posts | Freshers may apply Opportunity in Pharmacopoeia Commission for Indian Medicine | Pharmacy Assistant, Research Officer, Scientific Officer, Director, Joint Director and More...- Total 28 posts Career for Freshers in Novartis as Associate Scientist - Formulation (Parental Topical) - M.Pharm freshers may apply Applications invited in Government of India for Drug Controller Officer - 64 posts | Freshers may apply “Women Scientists Scheme (WOS-C)” on IPR, a scheme of Department of Science & Technology, Government of India more QUICK LINKS Course wise Alerts D.Pharm Alerts PharmaTutor Pharmacy Infopedia Vacancies Pharmapedia Articles Projects PharmaQuiz GPAT-Tutor Placements PharmaShine-2011 Conferences Forum Search Home Pharma News Career Watch Jobs Exam alerts Scholarship FAQ Subscribe Ads by Google Job Pharma HPLC Analysis Soil Analysis Bulk Chemical Calcitriol www.cerbios.ch Cerbios-Pharma, Switzerland GMP manufacture ,US-DMF, CEP,... Chemical Crystallography www.rigaku.com Inexpensive benchtop XRD system to determine small molecule structure Chemical & Material Tests www.alliancetechgroup.com Comprehensive analytical laboratory for complex, non-routine testing Opus™ Disposable Columns www.repligen.com/bioproc Cost effective pre-packed columns for single-use bioprocessing Pharma Analysis | PharmaTutor http://www.pharmatutor.org/pharma-analysis 1 of 4 1/19/2012 1:27 AM

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Page 1: Pharma Analysis _ Pharma Tutor

YOU ARE HERE Pharma Analysis

Pharma Analysis

Pharmaceutical AnalysisINTRODUCTIONPharmaceutical analysis is a branch of practical chemistry that involves a series

of process for identification, determination, quantification and purification of a

substance, separation of the components of a solution or mixture, or

determination of structure of chemical compounds.

The substance may be a single compound or a mixture of compounds and it may bein any of the dosage form. The substance used as pharmaceuticals are animals,plants, micro organisms, minerals and various synthetic products.

The sample to be analysed is called as analyse and on the basis of size of sample,they can be classified as macro(0.1 g or more), semi micro (0.01 g to 0.1 g),micro(0.001 g to 0.01 g), sub micro (0.0001 g to 0.001 g), ultramicro (below 10-4g), trace analysis(100 to 10000 ppm). Among all, the semi micro analysis is widelyused.

TYPESThere are main two types of chemical analysis.

1. Qualitative (identification)

2. Quantitative (estimation)

1. Qualitative analysis is performed to establish composition of natural/syntheticsubstances. These tests are performed to indicate whether the substance orcompound is present in the sample or not. Various qualitative tests are detection ofevolved gas, formation of precipitates, limit tests, colour change reactions, melting

SUBSCRIBE WITH US

Enter your emailaddress:

Do Not Forget to Verify(Click on

Subscription link inyour inbox)

ACTIVE FORUM TOPICS

NOTIFICATIONMHT-CET-2012 |Government of

TODAY'S POPULARCONTENT

Vacancy as DRUGINSPECTOR inGovernment of India,APSPSC - 56 posts |Freshers may apply

Opportunity inPharmacopoeiaCommission forIndian Medicine |Pharmacy Assistant,Research Officer,Scientific Officer,Director, JointDirector and More...-Total 28 posts

Career for Freshers inNovartis as AssociateScientist -Formulation (ParentalTopical) - M.Pharmfreshers may apply

Applications invitedin Government ofIndia for DrugController Officer -64 posts | Freshersmay apply

“Women ScientistsScheme (WOS-C)” onIPR, a scheme ofDepartment ofScience &Technology,Government of India

more

QUICK LINKS

Course wise

Alerts

D.Pharm Alerts

PharmaTutorPharmacy Infopedia

Vacancies Pharmapedia Art icles Projects PharmaQuiz GPAT-Tutor Placements PharmaShine-2011 Conferences Forum

SearchHome Pharma News Career Watch Jobs Exam alerts Scholarship FAQ Subscribe

Ads by Google Job Pharma HPLC Analysis Soil Analysis Bulk Chemical

Calcitriol www.cerbios.ch

Cerbios-Pharma, Switzerland GMP manufacture,US-DMF, CEP,...

Chemical Crystallography www.rigaku.com

Inexpensive benchtop XRD system to determinesmall molecule structure

Chemical & Material Tests www.alliancetechgroup.com

Comprehensive analytical laboratory forcomplex, non-routine testing

Opus™ Disposable Columns www.repligen.com/bioprocessing

Cost effective pre-packed columns forsingle-use bioprocessing

Pharma Analysis | PharmaTutor http://www.pharmatutor.org/pharma-analysis

1 of 4 1/19/2012 1:27 AM

Page 2: Pharma Analysis _ Pharma Tutor

point and boiling point test etc.

2. Quantitative analytical techniques are mainly used to quantify any compound orsubstance in the sample. These techniques are based in (a) the quantitativeperformance of suitable chemical reaction and either measuring the amount ofreagent added to complete the reaction or measuring the amount of reaction productobtained, (b) the charatristic movement of a substance through a defined mediumunder controlled conditions, (c) electrical measurement, (d) measurement of somespectroscopic properties of the compound.

Various types of Qualitative analysis:1.Chemical methodsa) volumetric or titrimetric methodsb) gravimetric methodsc) gasometric analysis2.Electrical methods3.Instrumental methods4.Biological and microbiological

Table of content:

Absorption Spectroscopy (UV, Visible)

IR Spectroscopy

---

1.Chemical methods

a)Titrimetric or volumetric method

It involves reaction of substance to be determined with an appropriate reagent

as a standard solution, and volume of solution required to complete the reaction

is determined. Volumetric methods require simple and less apparatus and they

are susceptible of high accuracy.

Various types of titrimetric methods are:

i)Acid-base titrations (neutralization reactions)

ii)Complexometric titrations

iii)Precipitation titrations

iv)Oxidation reduction titrations

v)Non aqueous titrations

b)Gravimetric methods

In gravimetric analysis, a substance to be determined is converted into an

insoluble precipitate in the purest form, which is then collected and weighed. It is

the time consuming process.

In electrogravimetry, electrolysis of the sample is carried out on the electrodes is

weighed after drying.

Thermogravimetry (TG) records the change in weight, differential thermal

analysis (DTA) records the difference in temperature between test substance and

an inert reference material, differential scanning calorimetry (DSC) records the

energy needed to establish a zero temperature difference between a test

substance and reference material.

c)Gasometric analysisGasometry involves measurement of the volume of gas evolved or absorbed in achemical reaction.Some of the gases which are analysed by Gasometry are CO2 , N2O,cyclopropane,amyl nitrate, ethylene, N2, helium etc.

2.Electrical methodsElectrical methods of analysis involve the measurement of electric current, voltage orresistance in relation to the concentration of some species in the solution.

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Page 3: Pharma Analysis _ Pharma Tutor

Electrical methods of analysis include:(a)Potentiometry(b)Conductometry(c)Polarography(d)Voltametry(e)Amperometry

Potentiometry measures electrical potential of an electrode in equilibrium with an ionto be determined. Conductometry measures electrical conductivity of an electrodewith a reference electrode while Polarography, Voltametry and Amperometrymeasures electrical current at a micro-electrode.

3.Instrumental methods of analysisInstrumental method involves measurement of some physical properties of thecompound or a substance. These methods are employed for determination of minoror trace concentration of element in the sample.Instrumental methods are preferred due to their selectivity, high speed, accuracy andsimplicity of analysis. Any change in the properties of the system are detected bymeasurement of absorbance, specific rotation, refractive index, migration difference,charge to mass ratio etc.Spectroscopic methods of analysis depend upon measurement of the amount ofradiant energy of a particular wavelength emitted by the sample.Methods which include absorption of radiation are ultra violet, visible, infra red,atomic absorption, nuclear magnetic resonance spectroscopy etc.Emission methods involve heating or electrical treatment of the sample so that theatoms are raised to the excited state to emit the energy and the intensity of thisenergy is measured. Emission methods include emission spectroscopy, flamephotometry, flourimetry etc.Chromatographic techniques and electrophoretic methods are separation methods forthe mixure of compounds, but also applied for identification of compounds ofmixures. Various chromatographic techniques are GC, HPLC, TLC, HPTLC, PC etc.Mass spectrometry involves vaporization of material using a high vaccum and thevapour is bombarded by a high energy electron beam. Vapour molecules undergofragmentation to produce ions of varying size. These ions are differentiated byaccelerating them in electrical field and then deflecting them in a magnetic field. Eachkind of ion gives a peak in the mass spectrum.

4.Biological and microbiological methodsBiological methods are used when potency of a drug or its derivative can not beproperly determined by any physical or chemical methods. They are calledbio-assays.

Microbiological methods are used to observe potency of antibiotic or anti- microbialagents. In antimicrobial assay, inhibition of growth of bacteria of the sample iscompared with that of the standard antibiotic. These methods include cup platemethod and turbidimetric analysis.

APPLICATIONSManufacturing industries require both qualitative and quantitative analysis to

ensure that their raw materials meet certain specifications, and to check the

quality of final product. Raw materials are to be checked to ensure that the

essential components are present within the predetermined range of composition

and there are not any unusual substances present which might upset the

manufacturing process or it may appear as a harmful impurity in the final

product.

In the development of new products which contains mixtures other then the pure

material, it is necessary to ascertain composition of mixture which shows the

optimum characteristics for which the material has been developed.

Geographical surveys require analysis to determine the composition of soil

sample and numerous rock samples collected from the field.

Most of the industrial processes give rise to pollutants which may cause health

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related problems. So quantitative analysis of air, water and soil sample should be

carried out to determine the level of pollution and to establish the safe limits for

pollutants.

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