Interim guide on isopropyl alcohol for use in alcohol-based hand sanitizers and disinfectants: Formulations and ingredients

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Recommended formulations

All formulations must meet all the safety and efficacy requirements established in Health Canada's antiseptic skin cleansers (personal domestic use) monograph.

IPA isn't an acceptable ingredient in Health Canada's hard-surface disinfectant monograph. As well as meeting the requirements in the antiseptic skin cleanser monograph, disinfectants must meet all the safety and efficacy requirements established in Health Canada's:

We recommend that you manufacture IPA-based hand sanitizers according to the WHO formulation below. This formulation ensures that impurities commonly found in the IPA do not exceed USP limits.

Formulation for a 10-litre preparation

The final preparation contains 75% IPA, 0.125% hydrogen peroxide, 1.421% glycerol and water.

Acceptable formulations should be consistent with the following guidelines:

Record-keeping

You must maintain records on how the hand sanitizer and disinfectant is prepared. Include details on how you came up with the final IPA dilution in the finished product.

You should calculate the amount of IPA needed in the formulation using the following equation (as set out in the USP guidance):

formula
Long description

You can calculate the volume of starting ingredient required by multiplying the final percentage of alcohol by the final volume of preparation, and then dividing by the starting percentage of alcohol.

Licence holders are responsible for ensuring the quality of their licensed products before releasing them for sale. You must keep all documentation, including approved product specifications, release records and certificates of analysis. You must also make them available at the request of Health Canada.

For alcohol-based hand sanitizers, records must include information on the establishment and maintenance of the product specifications (see section 44 of the Natural Health Products Regulations (NHPR)). Each batch or lot of finished product must meet these specifications.

All alcohol-based hand sanitizers must be manufactured, packaged, labelled and imported using good manufacturing practices (GMP), which are outlined in part 3 of the NHPR. This includes maintaining GMP records for 1 year after the product has expired (sections 53 to 58 of the NHPR).

If another party produces the product for you, the roles and responsibilities for the development, maintenance and storage of this data and records should be clearly established.

Non-medicinal and inactive ingredients

All non-medicinal ingredients (NMIs) used in a hand sanitizer must be listed in Health Canada's natural health products ingredient database. Sponsors of disinfectants may also consult this database for inactive ingredients.

If you use non-sterile water instead of sterile water, you should monitor the water system all the time. Bacterial counts must be within acceptable ranges for IPA (see applicable good manufacturing guidance for additional information on microbial testing). This may necessitate taking additional precautions to prevent contamination. Additional testing is also required to ensure quality of the finished product before distribution (for instance, sale or donation).

Any substitutions must be ingredients identified in the database and you must notify Health Canada when making a change. We will contact you if we have concerns.

If the NMI or inactive ingredient that you intend to use isn't listed in the database, you may request to have it added. Fill out a natural health products ingredients database issue form and email it to hc.ingredient.support.sc@canada.ca. We will review your request to determine if we should add the NMI or inactive ingredient.

Product licence holders should refrain from using priority food allergens in their products. This is particularly important for products used in public settings. We want to help ensure that everyone can use these products. For more information on priority food allergens, please see our common food allergens page. For more information on restrictions to NMIs and inactive ingredients, please see the guidance document on licensing to produce and distribute alcohol-based hand sanitizers.

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