News

head uk2

How to read our certificate of analysis?

A certificate of analysis (CoA) is a document that confirms that the product meets its product specifications and is issued for each batch of product by quality assurance. The certificate of analysis contains the specifications for the specified parameters and the actual results of analysis of the parameters for this product batch. The certificate of analysis is sent together with the product to our customers. In the following we explain in detail how to read a certificate of analysis of our chitosan products and how can you cite it in your scientific articles.

Tags: CoA, Certifiate of Analysis, Quality control

Reading our CoA from Top to Bottom

Company Info - At the top of the certificate of analysis, on the right-hand side, you will find our company information.

General product information:

Product line - The first information you get is about the quality class of your chitosan product. Our product lines are called Chitoscience®, Chitoceuticals® and Chitoceutical® GMP compliant. Learn more.

Product – Product name: Chitosan or chitosan derivative
CAS – unique numerical identifier assigned by the chemical abstract services
Product No. – HMC article number of the product
Batch No. – Assigned by HMC as an identification number. It allows to trace the production history of the product at HMC.
Storage conditions – Recommendations about how to store the Chitosan product to maintain its quality
Production date – The day our production team did its best to produce our chitosan with highest quality
Expiry date – The date after which the chitosan product should no longer be used as the anticipated shelf life is exceeded. But you can always get new material in our shop.

Testing information
In the middle part of the document is a table with four columns.

Column 1: Parameter - What kind of quality parameters were tested for this product? How many parameters are tested depends on the product quality you ordered. Learn more.

Column 2: Method - What method was used for analysis? Analytical methods are described in protocols and scientifically fit for the purpose.

Column 3: Limit – What are the specified limits for results of the listed parameters? – Limits are defined in the specification for the product.

Column 4: Result – What are the results of the analysed parameters specifically for this product with the above batch number?

If a product is tested and does not meet its specifications, it will not be sold by HMC. All certificates of analysis are dated and signed by the head of quality assurance and quality control.

The molecular weight is analysed by GPC and stated on the certificate of analysis only for GMP compliant products. The molecular weight is not analysed for Chitosans of our quality lines Chitoscience® and Chitoceuticals®. For Chitoceuticals® products we provide the molecular weight range for reference. You can always order the analysis of molecular weight. Find out more.

The certificate of analysis is sent together with the product to our customers. In case you are missing the certificate of analysis of your chitosan produced by HMC please send us an e-mail with the product batch number. We are happy to send you the corresponding certificate of analysis.
If you refer in an article about our chitosans please refer in the material and method section to the "product", Heppe Medical Chitosan (Halle, Germany) and you can mention the real data from the CoA for parameter degree of deacetylation and viscosity to be found in the column "Result".

 About used terms:

  • ppm stands for “parts per million”
  • CFU / g substance stands for “colony-forming units per gram substance (chitosan)”
  • “total bacterial count” indicates how many microorganisms are present in the sample. A limit is set which must not be exceeded.
  • “absent” result indicates that this chitosan product does not contain the bacteria it was tested for (certain bacterial strains are tested for Chitoceutical® GMP complaint products produced in our clean room class C)

Congress and fairs

Meet us in person 2020:

  • EUCHIS, 6 - 10 September 2020 Kazan, Russia
  • CPHI 13 - 15 October 2020, Fiera Milano, Italy
  • Medica 16 - 19 November 2020, Düsseldorf, Germany
  • Asia Pacific Chitin and Chitosan Symposium, 6 - 9 December 2020, Jeju-si, South Korea

To arrange an appointment please contact Katja Richter via sales(at)medical-chitosan.com

Contact

  • Heppe Medical Chitosan GmbH
    Heinrich-Damerow-Strasse 1
    06120 Halle (Saale)
    Germany
  • Tel.: +49 (0) 345 27 996 300
    Fax: +49 (0) 345 27 996 378
  • sales@medical-chitosan.com

We use cookies on our website. Some of them are essential for the operation of the site, while others help us to improve this site and the user experience (tracking cookies). You can decide for yourself whether you want to allow cookies or not. Please note that if you reject them, you may not be able to use all the functionalities of the site.