determination of related substances impurities in drugs by ich guide lines l.
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DETERMINATION OF RELATED SUBSTANCES & IMPURITIES IN DRUGS BY ICH GUIDE LINES - PowerPoint PPT Presentation


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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
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
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
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
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
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.

ich guidelines international conference on harmonization
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
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
CO SPONSORS OF ICH.
  • EC-EU.
  • EFPIA.
  • MHW
  • JPMA
  • FDA
  • PRMA
functions
FUNCTIONS.
  • HAS EQUAL PARTICIPATION IN THE PROCESS & EACH HAS TO SEAT ON THE STEARING COMMITTEE , WHICH OVERSEAS HARMONISATION ACTIVITIES.
who govern ich
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
AREAS OF ICH GIDELINES
  • STABILITY.
  • ANALYTICAL VALIDATION.
  • IMPURITIES.
  • PHARMACOPOEIAS.
  • BIOTECHNOLOGICAL QUALITY.
  • GMP.
  • TOXICITY.
  • KINETICS.
  • REPRODUCTIVE KINETICS.
  • CARCINOGENCITY.
slide14
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
Individual Harmonisation topics
  • Safety.
  • Quality
  • Efficacy
  • Multidisciplinary
selection of topics
Selection of Topics
  • Step 1
  • Step 2
  • Step 3
  • Step 4
  • Step 5