Advertisement
/ 25 []

DETERMINATION OF RELATED SUBSTANCES & IMPURITIES IN DRUGS BY ICH GUIDE LINE...


Download Presentation

DETERMINATION OF RELATED SUBSTANCES IMPURITIES IN DRUGS BY ICH ...

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use only and may not be sold or licensed nor shared on other sites. SlideServe reserves the right to change this policy at anytime.While downloading, If for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.











- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -




Presentation Transcript


Determination of related substances impurities in drugs by ich guide lines l.jpg

DETERMINATION OF RELATED SUBSTANCES & IMPURITIES IN DRUGS BY ICH GUIDE LINES

BY

M.PAUL RICHARDS


Introduction l.jpg

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 l.jpg

ANALYTICAL PROCEDURES

  • 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)


Slide4 l.jpg

  • 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.


Slide5 l.jpg

  • Should be validated for specified & unspecified conditions & used to estimate ,identify & unidentify deg.products.

  • Diff.used during development proposed to commercial

    product should be discussed.


Residual solvents l.jpg

RESIDUAL SOLVENTS

  • 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.


For isolating and identifying process related impurities using l.jpg

For Isolating and Identifying process related Impurities using

  • MS

  • NMR

  • HPLC

  • FTICR-MS

  • LC-MS.


Ich guidelines international conference on harmonization l.jpg

ICH GUIDELINES (INTERNATIONAL CONFERENCE ON HARMONIZATION)

  • 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.


Objective l.jpg

OBJECTIVE

  • 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.


Co sponsors of ich l.jpg

CO SPONSORS OF ICH.

  • EC-EU.

  • EFPIA.

  • MHW

  • JPMA

  • FDA

  • PRMA


Functions l.jpg

FUNCTIONS.

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


Who govern ich l.jpg

WHO GOVERN ICH

  • 1.Six founder members of ICH.

  • 2.OBSERVERS:

    A.WHO B.EFTA

    C.HPB

    3.SECRETERIATES (PROVIDED BY JFPMA)


Areas of ich gidelines l.jpg

AREAS OF ICH GIDELINES

  • STABILITY.

  • ANALYTICAL VALIDATION.

  • IMPURITIES.

  • PHARMACOPOEIAS.

  • BIOTECHNOLOGICAL QUALITY.

  • GMP.

  • TOXICITY.

  • KINETICS.

  • REPRODUCTIVE KINETICS.

  • CARCINOGENCITY.


Slide14 l.jpg

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”


Individual harmonisation topics l.jpg

Individual Harmonisation topics

  • Safety.

  • Quality

  • Efficacy

  • Multidisciplinary


Status of ich guide lines l.jpg

Status of ICH GUIDE LINES:

EFFICIENCY TOPICS


Safety topics l.jpg

SAFETY TOPICS


Quality topics l.jpg

QUALITY TOPICS


Selection of topics l.jpg

Selection of Topics

  • Step 1

  • Step 2

  • Step 3

  • Step 4

  • Step 5


Slide24 l.jpg

BY