Determination of related substances impurities in drugs by ich guide lines
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DETERMINATION OF RELATED SUBSTANCES & IMPURITIES IN DRUGS BY ICH GUIDE LINES. BY M.PAUL RICHARDS. INTRODUCTION. ANALYTICAL PROCEDURES. RESIDUAL SOLVENTS ICH GUIDELINES CO - SPONSORS OF ICH. WHO GOVERN ICH AREAS OF ICH GUIDE LINES. THE STATUS OF ICH GUIDE LINES. ANALYTICAL PROCEDURES.

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Introduction l.jpg
INTRODUCTION ICH GUIDE LINES

  • ANALYTICAL PROCEDURES.

  • RESIDUAL SOLVENTS

  • ICH GUIDELINES

  • CO - SPONSORS OF ICH.

  • WHO GOVERN ICH

  • AREAS OF ICH GUIDE LINES.

  • THE STATUS OF ICH GUIDE LINES.


Analytical procedures l.jpg
ANALYTICAL PROCEDURES ICH GUIDE LINES

  • Suitable for detection & quantification of degradation products. (HPLC & TLC).

  • For determination of related substances & degradation products.

  • Sample stored under stress conditions (light , heat, humidity, acid/base hydrolysis & oxidation)


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  • Other peaks should be labelled in the chromatogram & discussed in documentation.

  • Quantification limit is >/ the reporting threshold.

  • Deg.product should be compared with analytical response of Deg.product to that of appropriate REFERENCE STD.

  • REFERENCE STD : Control of deg .products should be

    evaluated & to their Intended use.


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RESIDUAL SOLVENTS used to estimate ,identify & unidentify deg.products.

  • Determine by using C.Technique such as GC.

  • Those describe in pharmacopoeias can be used for determination .

  • If only class 3 solvents are present ,non specific method

    used on loss on drying.



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ICH GUIDELINES (INTERNATIONAL CONFERENCE ON HARMONIZATION) using

  • DEF: This is a process by which the organising authorities of the US, European commission Japan & experts from pharmaceutical industries & the trade association in the three region are brought together to discuss about the scientific and technical aspects of PRODUCT REGISTRATION.


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OBJECTIVE using

  • To discuss scientific & technical aspects of medicinal product registration.

  • Discuss b/w regulatory authorities and the pharmaceutical industry on the real and perceived differences.

  • To identify an area where modification in technical requirements could lead to a more economical use .

  • To make recommendations on practical ways.

  • To achieve greater harmonisation in interpretation & application of technical guidelines & requirements for registration.


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CO SPONSORS OF ICH. using

  • EC-EU.

  • EFPIA.

  • MHW

  • JPMA

  • FDA

  • PRMA


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FUNCTIONS. using

  • HAS EQUAL PARTICIPATION IN THE PROCESS & EACH HAS TO SEAT ON THE STEARING COMMITTEE , WHICH OVERSEAS HARMONISATION ACTIVITIES.


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WHO GOVERN ICH using

  • 1.Six founder members of ICH.

  • 2.OBSERVERS:

    A.WHO B.EFTA

    C.HPB

    3.SECRETERIATES (PROVIDED BY JFPMA)


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AREAS OF ICH GIDELINES using

  • STABILITY.

  • ANALYTICAL VALIDATION.

  • IMPURITIES.

  • PHARMACOPOEIAS.

  • BIOTECHNOLOGICAL QUALITY.

  • GMP.

  • TOXICITY.

  • KINETICS.

  • REPRODUCTIVE KINETICS.

  • CARCINOGENCITY.


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4 EWG is further divided into a member of working topic groups for which a RAPPORTEUR.

STEERING COMMITTEE IS ADVISED BY EXPERT WORKING GROUP ON TECHNICAL ISSUES .

On the basis of “CONCEPT PAPER”


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Individual Harmonisation topics groups for which a RAPPORTEUR.

  • Safety.

  • Quality

  • Efficacy

  • Multidisciplinary


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Status of ICH GUIDE LINES: groups for which a RAPPORTEUR.

EFFICIENCY TOPICS


Safety topics l.jpg
SAFETY TOPICS groups for which a RAPPORTEUR.


Quality topics l.jpg
QUALITY TOPICS groups for which a RAPPORTEUR.


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Selection of Topics groups for which a RAPPORTEUR.

  • Step 1

  • Step 2

  • Step 3

  • Step 4

  • Step 5


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BY groups for which a RAPPORTEUR.