Enzyme Purchasing/Specification Questions
Enzymes, such as pepsin and panreatin, have different expression in different pharmacopeias.
Spelling out in advance what the requirements are from the formulation department can help buyers and suppliers best match their needs. Buyers who get the answers to these questions from their formulators and suppliers ensure their time is well spent, and the ultimate product meets specifications.
1.What type of enzyme do we need? (e.g., protease, amylase)
2.What source of the enzyme is best? (e.g., A. oryzae, B. subtilis, pancreatin)
3.What is the activity required? (e.g., Amylase skb/g vs. DU/g)
4.Is the assay method published or available?
5.What is the expression of activity? (e.g., unit/gram, unit/mg)
6.What is the standardizing agent? (e.g., maltodextrin, starch)
7.Will the enzyme activity be part of the label?
8.Will there be any stated guarantee of enzyme activity on the label?
9.Are written specifications available to give to the vendor?
10.Who tests the quality standards? (e.g., vendor, third party)
11.Are other certifications, such as kosher or halal, required?
12.Is the product free of other ingredients? (e.g., wheat, lactose)
Of course, if you are not familiar with these questions, we would also like to communicate with you one by one, just send e-mail to info@xsbiopharm.com