Interim guide on isopropyl alcohol for use in alcohol-based hand sanitizers and disinfectants: Quality requirements

Acceptable quality grades

As outlined in the Quality of Natural Health Products Guide, isopropyl alcohol (IPA) used in the production of hand sanitizers should meet identity and purity criteria. You can find these criteria in any of the following quality standards:

Please note that while some references are free, others require payment for full access. Also note that USP isn't charging for the USP-NF and FCC monographs during the COVID-19 pandemic.

For an IPA to be considered an acceptable quality standard grade, companies must include requirements such as:

use a synthetic and distillation process
follow good manufacturing practices typically used in the manufacturing of drugs or natural health products
ensure that no other chemicals have been added to the IPA
have appropriate quality assurance and quality control measures in place to detect any accidental introduction of impurities into the IPA

Alternate quality grades

You must test your IPA using specified tests and methodologies outlined in the relevant standard to see if it's equal to or higher than the quality standards listed above.

Unlike with technical-grade ethanol, we're not issuing separate approvals for the use of technical-grade IPA in the manufacturing of hand sanitizers or disinfectants. Companies must therefore:

ensure the quality of all raw materials used in the manufacturing process
conduct the necessary tests to ensure the quality of their finished product

If you're unable to or don't have the expertise to interpret quality test results, we encourage you to engage the services of a qualified expert.

Health Canada will review all applications for safety, efficacy and quality evidence. However, it's your responsibility to make sure your product is compliant, as applicable, with either the:

Food and Drugs Act(FDA) and Natural Health Products Regulations (NHPR) or
FDA and Food and Drug Regulations

Technical-grade IPA

Technical-grade IPA differs from the acceptable grades listed above. It is a broad term covering a wide range of purity and contaminant profiles.

The technical grades of IPA below are grades that the industry doesn't usually use in health products. However, these 2 grades may also meet or exceed Health Canada's quality expectations:

American Chemical Society (ACS) grade: This grade is acceptable for food, drug or medicinal use. It's used for ACS applications or for general procedures that require stringent quality specifications.
Reagent grade: Equal to the ACS grade, the reagent grade is acceptable for food, drug or medicinal use. It's suitable in many laboratory and analytical applications.

For technical grades, companies must conduct additional tests to identify and account for all the impurities found in the IPA. The USP monograph for IPA provides information on these tests and acceptable testing methods. Tests include:

identification tests (infrared absorption)
impurities tests (identity and quantity) for volatile impurities and non-volatile residues
tests for gravity, refractive index, acidity and water to determine:

if the product meets acceptable quality standards or
how far away the product is from meeting those standards

You must ensure that:

the testing methods are those outlined in the current version of the USP monograph (including information found in all applicable USP chapters) to determine if the quality is acceptable
the total percentage of impurities doesn't exceed that set out in the acceptable quality standard
no single impurity exceeds established thresholds in the acceptable quality standard
quality controls are in place to prevent mixing or contamination

Any technical-grade product must be consistent with the type of raw material that industry typically uses for food, drugs and medicinal products. It must also have no other additives or other chemicals added to the IPA. Because of the potential for the presence of potentially harmful impurities, you should take great care to ensure other chemicals on site are not accidentally introduced into the IPA.

You must have a licence (indicated by an NPN or DIN) to sell your product. To manufacture, package, label and/or import alcohol-based hand sanitizers, you need a site licence. If you're a fabricator, packager/labeller, distributor, importer or tester of a disinfectant, you don't need an establishment licence.

Even though the licence doesn't specify the type of IPA permitted for use, we expect the IPA to meet an acceptable quality standard.

Notify us when using technical-grade IPA

If you plan to use technical-grade IPA in your hand sanitizer and/or disinfectant, you must notify us before you release it for sale, even if you have a licence. We will then be able to contact you when this interim approach allowing technical-grade IPA to be used in hand sanitizers and disinfectants ends.

Notify us by emailing the Natural and Non-prescription Health Products Directorate at hc.rmd.coordination-dgr.sc@canada.ca. Use the following subject line COVID-19 - Notification of technical grade IPA use in hand sanitizer/disinfectant.

Your notification must include:

the name of company
the product number or drug identification number and site licence for the product
a statement attesting that the IPA meets, is the equivalent of or exceeds an acceptable quality grade listed above
the grade used
the purity criteria used

Once you have submitted your notification, you may:

manufacture, package, label and/or import your disinfectant using technical-grade IPA
if you have a site licence, manufacture, distribute or import alcohol-based hand sanitizer using technical-grade IPA

You may also email the Natural and Non-prescription Health Products Directorate at hc.rmd.coordination-dgr.sc@canada.ca if you have questions about technical-grade IPA.

Unacceptable grades

Laboratory/electronic-grade IPA is used for educational purposes (in school labs, for example) or to clean electronic equipment. However, impurities in these grades can't be detected by food or drug analysis methods suited for products used for human application. For this reason, this type of IPA can't be used in hand sanitizers or disinfectants produced or imported in Canada.

The isopropyl alcohol you use for your product should:

conform to one of the listed pharmacopoeia standards or
be a technical-grade product that meets the requirements outlined in the interim guide for the production of isopropyl alcohol for use in alcohol-based hand sanitizers and
meet the requirements outlined in the quality of natural health products guide

The IPA may not be used as a raw ingredient in a hand sanitizer or disinfectant if you can't:

attest that your IPA meets quality standards
provide documented evidence to support this attestation when asked

Note: It is the responsibility of the product licence holder to verify compliance.

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2021-01-11