Name of the ingredient
Amylase derived from Aspergillus oryzae (ABN)
Definition of the ingredient
Amylase (1,4-α-D-glucan glucanohydrolase) is an enzyme that is commercially derived from the fungus, Aspergillus oryza, via a fermentation process. During the recovery phase of production, manufacturers destroy A. oryzae before removing the non-proteinaceous material away from amylase. Amylase recovered from the fermentation broth is usually present in an aqueous solution or processed to a dried state.
CAS No. 9000-90-2
EC No. 3.2.1.1
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Description | ||
| Appearance | Visual | Liquid or powder |
| Identification | ||
| Amylase activity | FCC | Complies |
| Assay | ||
| Amylase activity | FCC | No less than 85.0% but no more than 115.0% of the declared activity expressed as DU* |
| Notes: * DU = alpha - amylase dextrinising unit | ||
| Test | Method reference | Acceptance criteria |
|---|---|---|
| Incidental metals and non-metals | ||
| Total heavy metals (as lead) | FCC | No more than 30 ppm |
| Lead | FCC | No more than 5 ppm |
| Other organic or inorganic impurities or toxins | ||
| Mycotoxins and aflatoxins | FCC, AOAC | Not detected |
| Antibiotic activity | JECFA | Not detected |
| Microbiology | ||
| While substance manufacturers are encouraged to include limits for objectionable microorganisms, it is the product into which those substances are formulated that is subject to a legally binding set of criteria. The Therapeutic Goods Order No. 77 'Microbiological Standards for Medicines' mandates that any finished product which contains the ingredient, alone or in combination with other ingredients, must comply with the microbial acceptance criteria set by Clause 9 of the Order. | ||
Key to abbreviations
AOAC = Association of Analytical Communities Official Methods of Analysis 16th Ed. AOAC
BP = British Pharmacopoeia
FCC = Food Chemicals Codex
JECFA = Joint FAO/ WHO Expert Committee on Food Additives in FAO Food and Nutrition Paper No.52 (Addendum 9)
Ph Eur = European Pharmacopoeia