The clear characterisation of chitosan by parameters and its analysing methods are being discussed for several years now. Research results are difficult to compare because there is no standard characterisation of chitosan yet, and different measuring methods may be used so that results are frequently not comparable on a one-to-one basis. The need to agree definitions/descriptions of chitin and chitosan and to harmonise measuring techniques is discussed repeatedly at international conferences. A standardized description and consistent measuring methods are especially important in the pharmaceutical and medical sectors where they are essential for their acceptance by regulatory authorities. This approval would ease the breakthrough of this magnificent polymer particularly in the pharmaceutical industry.

To push the standardization process ten parameters were proposed at the ICCC in Taipei to characterise chitosan. These are:

    1.   Identity - for example IR spectrum
    2.   Appearance of powder
    1.   Identity - for example IR spectrum
    2.   Appearance of powder
    3.   Degree of deacetylation
    4.   Viscosity
    5.   Loss on drying/dry matter content
    6.   Ash content
    7.   Protein content
    8.   Heavy metal content (Pb, Hg, Cd)
    9.   Microbiological quality (total viable count, fungi)
    10. Endotoxin level

The measuring methods also need to be harmonised since different methods of analysis may, in some cases, lead to different results for the same parameter. To determine the most common and practicable method of analysis for each parameter, the initiation of an inter-lab comparison program was decided at the ICCC 2009 in Taipei. The aim is to standardize chitosan and the methods for its analysis on an international level.

So now research institutions and manufacturing companies are urged to participate in the program. EUCHIS board member Katja Heppe is entrusted with the organisation of the inter-lab program. Research and industrial partners are kindly asked to fill in the participation form(s) and send it (them) to Katja Richter.

Schedule

a) In a first step participants (laboratories and producers if desired) are kindly asked to provide information on the parameters they would like to examine and the analysing methods as well as the amount of chitosan required (see forms on above mentioned website). Deadline: July 15.

b) In the meantime chitosan producers are requested to provide several samples including certificates (addressed to Heppe Medical Chitosan GmbH). All samples will be gathered centrally and then distributed according to the amount needed. Deadline: July 23.

c) The samples will be sent to all participating laboratories and producers who are interested in carrying out the analyses. Deadline: October 22.

d) The laboratories will analyse the parameters according to their methods and send the results back to Katja Heppe.  The needed form is downloadable below. Deadline: February 28. *

e)  The results will then be collected and sent to all participants and the chitin and chitosan societies. Deadline: April 8.

f) The results are up for discussion until April 29. Please send us your comments and suggestions via email.

g) Results and comments will be pooled and then presented at the Conference of the EUCHIS in St. Petersburg. Where further steps can be evaluated.

Please note that there is no official fund for this program. Neither the costs of providing samples for participants to analyse, nor the costs incurred in analysing them, can be covered. The distribution of samples to all participants involved in their analysis, and the provision of the summary as well as the final report, will be paid for by Heppe Medical Chitosan. The participation is voluntary, but would be very much appreciated.

We all hope for the support of the whole chitosan community to successfully effect the program. Please participate as researchers or producing partners to identify important parameters and validate appropriate measuring methods of analysis. Take your share in the standardization of chitosan and support enhancing the potential of chitosan. Standardization would mean a breakthrough because then the main condition for accepting chitosan for pharmaceutical applications by regulatory authorities would be fulfilled.

You would like to effect analyses? Please use the [pdf] analysing partner form.

You would like to provide chitosan samples? Please use the [pdf] sample supplier form.

How to proceed? Please fill in the form(s), print and sign it and send it via fax or standard mail to the below fax-number/address. You can also scan the signed form and send it via This email address is being protected from spambots. You need JavaScript enabled to view it..

* Results

You analysed the samples. Please fill in the results in the following form:

[pdf]  Analysis_form.pdf
Please use one form per parameter to be analysed. The Form is saveable only in the programm Adobe Acrobat Professional. In Adobe Reader you can only print it or send it via e-mail. In any case, please fill in the form, sign it and send it to us via e-mail as a scanned file of via fax.

For any further questions or suggestions please contact Katja Richter via This email address is being protected from spambots. You need JavaScript enabled to view it..

 
Heppe Medical Chitosan GmbH
Heinrich-Damerow-Str. 1
06120 Halle (Saale)
Germany