The ideal supplier of your medical-grade chitosan should be able to provide you with advice and guidance in choosing the most suitable chitosan for your project. This includes one that is able to provide you with a variety of choices of high-quality products. They should also help you identify the chitosan with the appropriate specifications for your application. To do so the supplier would need to know the application and chitosan functionalities you are targeting. This will better allow them to suggest chitosan that has specifications that can align with your needs. At the beginning of your relationship with a supplier make sure to provide them only with non-confidential information.
Choosing the Best Quality Medical Grade Chitosan
Once the chitosan with the appropriate specifications is identified, you need to ensure its quality meets the requirements for your application. The following chitosan quality measures should be evaluated and monitored;
- Purity
Chitosan’s degree of Deacetylation (DDA%) is considered a measure of its purity. The higher its DDA%, the higher its quality. For example, DDA% ≥95 is considered high-quality chitosan.
- Impurities
Chitosan quality is also determined by the amount of impurities it contains, such as its protein content, ash, heavy metals, and microbes.
Regulatory agencies, such as the FDA and the USP set allowable limits of these impurities that can be in medical grade chitosan. Exceeding these limits could raise questions and concerns from these agencies, and ultimately prevent your product from getting approved.
- Consistency and Reproducibility
Products containing medical grade chitosan are intended to be used for medical purposes. Therefore, they must be of high quality that is consistent and reproducible. Every batch of medical-grade chitosan must be produced to provide the same chitosan every time. The parameters of chitosan that must be measured and monitored for consistency include: Degree of Deacetylation (%), Particle size (mm), Ash content (%), Residue on ignition, Molecular Weight (kDa), Bulk density, pH, Moisture content (%), Viscosity (cps), Solubility (%), Protein content (%), Appearance, Heavy metals (ppm) and Microbial counts.
After selecting the right chitosan it can be incorporated into a variety of different medical applications including:
- Drug delivery and transport facilitators
- Tissue engineering and regeneration
- Medical devices and implants
- Wound care
- Haemostat
- Vaccines
- 3D printing
- Etc.
What to Know About Your Medical Chitosan Supplier?
When looking for the best supplier for your medical grade chitosan, start with search engines, such as Google, Bing, Safari, FireFox, etc. Search for various terms such as “medical grade chitosan” and “medical chitosan”. Also search on industry directories such as, ThomasNet and Knowde. Then cross reference your findings on search engines with the directories, and narrow your options to 2 or 3 suppliers to examine them in detail.
You should examine the following items:
- Company profile
Get information about the companies and their products from their websites and the industry directories. Access how they present themselves, their products. Then contact them by email or phone.
- Product information
Once you make contact, get detailed product information by addressing the following:
- Chitosan products available and their specifications.
If you don’t know the chitosan you need, ask them to suggest one. - Once a product(s) is identified, ask for its Specifications Data Sheet (SDS) or Certificates of Analysis (CoA).
- Discuss the product’s manufacturing certifications such as, Good Manufacturing Practices (GMP), International Standards Organization (ISO), etc.
They should also tell you about the support services they provide, such
as guidance with product selection and access to technical assistance.
- Purchasing
After identifying the product(s) with the specifications that could meet your needs, get information on the following items related to purchasing:
- Pricing
Get the price for the product and its total cost thats includes its shipping & handling - Samples
Request a sample to perform basic experiments to determine if the chitosan chosen has the physicochemical characteristics and behaviors needed for your application. - Minimum Order Quantity
Ask for what is the company’s minimum amount of chitosan that is required to be purchased. - Lead-time
Ask how long it takes to receive the product once it is ordered. - Terms of payment
Find out when you have to pay for the product you order. - Volume capacity
Ask how much volume of chitosan the company can produce and the time it takes to get you larger volumes if it is required. - Other items
- Geographic footprint – know their location and reach. Find out if they supply their products locally, nationally, or internationally.
- Check on the number of products they supply other than chitosan. The more different products they supply the less knowledgeable they may be with chitosan.
- Enquire about their experience with supplying medical grade chitosan for research and for commercial products.
- Existing customers – request a list of their customers as it can provide you with references in doing business with the supplier.
Choosing the best medical grade chitosan for your academic or commercial R&D project is critical. The chitosan must be of high and consistent quality from batch-to-batch every time it is manufactured. Equally important is choosing the best chitosan supplier. They should be able to provide you with assistance in selecting the best chitosan and ensure that you receive the high and consistent quality chitosan. Make sure to invest time in searching for a chitosan supplier that meets these needs. The selection of your medical grade chitosan can mean the difference between a successful or failed R&D project.
