determination of related substances impurities in drugs by ich guide lines
Download
Skip this Video
Download Presentation
DETERMINATION OF RELATED SUBSTANCES & IMPURITIES IN DRUGS BY ICH GUIDE LINES

Loading in 2 Seconds...

play fullscreen
1 / 25

DETERMINATION OF RELATED SUBSTANCES IMPURITIES IN DRUGS BY ICH ... - PowerPoint PPT Presentation


  • 898 Views
  • Uploaded on

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.

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'DETERMINATION OF RELATED SUBSTANCES IMPURITIES IN DRUGS BY ICH ...' - arleen


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 and may not be sold / licensed / shared on other websites without getting consent from its author.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
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
ad