ALPHA-AMYLASE

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient.

Notes

Date

January 26, 2024

Proper name(s), Common name(s), Source information

Table 1. Proper name(s), Common name(s), Source information
Proper name(s) Common name(s) Source information
Source material(s) Part(s)
4-alpha-D-Glucan glucanohydrolase
  • 1,4-alpha-D-Glucan glucanohydrolase
  • alpha-Amylase
  • Diastase
  • Fungal diastase
  • Taka-Diastase (Aspergillus)
  • Aspergillus niger
  • Aspergillus flavus var. oryzae
Whole
Hordeum vulgare Seed
Rhizopus oryzae whole

References: Proper name: IUBMB 2023; Common names: IUBMB 2023; Source information: CABI 2023; COL 2023; USDA 2023; FCC 8 2012.

Route of Administration

Oral

Dosage Form(s)

This monograph excludes foods or food-like dosage forms as indicated in the Compendium of Monographs Guidance Document.

Acceptable dosage forms for oral use are indicated in the dosage form drop-down list of the web-based Product Licence Application form for Compendial applications

Use(s) or Purpose(s)

Digestive enzyme

Dose(s)

Subpopulation(s)

Adults 18 years and older

Quantity(ies)

No to exceed 150,000 FCC DU of enzymatic activity, per day; and 34,000 FCC DU per single dose (FCC 8 2012; Glade et al. 2001)

Notes

Direction(s) for use

All products

Take with food/meal.

Enteric-coated products

Swallow whole/Do not crush or chew (CPS 2008).

Duration(s) of Use

Ask a health care practitioner/health care provider/health care professional/doctor/physician for prolonged use.

Risk Information

Caution(s) and warning(s)

Contraindication(s)

No statement required.

Known adverse reaction(s)

Stop use if hypersensitivity/allergy occurs (Martindale 2023).

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.

Storage conditions

Must be established in accordance with the requirements described in the Natural Health Products Regulations.

Specifications

EXAMPLE OF PRODUCT FACTS:

Consult the Guidance Document, Labelling of Natural Health Products for more details.

Product Facts Table

References Cited

References Reviewed