Heavy Metal Testing for concentrates and infused products starts April 1.

On April 1, 2020, Heavy Metal testing will be required for Concentrates and Infused Products. With 420 fast approaching and the COVID-19 epidemic, labs may experience long delays in turn times.

Agricor is ready to assist you with fast turn times with no back logs or delays!

Please call your sales representative or our support line at: (720) 460-3489 to learn more or to set up a sample pick-up.

What you need to know?

Let’s break down the important details for this new rule:

  • Required production batches
  • Allowable Limits
  • Process Validation

Required Production Batches

Heavy Metal testing for Concentrates and Infused Products is required on all Production Batches created on or after April 1, 2020. Production batches created prior to April 1, 2020 are not required to be tested for Heavy Metals.

Allowable Limits

Each product type has a different allowable limit for heavy metals.

Inhaled

  • Pb – Max Limit: < .5 ppm
  • Ar – Max Limit: < 0.2 ppm
  • Ca – Max Limit: < 0.2 ppm
  • Hg – Max Limit: < 0.1 ppm

Includes inhaled Audited Products: Administration by metered dose nasal spray or pressurized metered dose inhaler.

Topical/Transdermal

  • Pb – Max Limit: < 10 ppm
  • Ar – Max Limit: < 3 ppm
  • Ca – Max Limit: < 3 ppm
  • Ar – Max Limit: < 1 ppm

Topical/Transdermal

  • Pb – Max Limit: < 1 ppm
  • Ar – Max Limit: < 1.5 ppm
  • Ca – Max Limit: < 0.5 ppm
  • Hg – Max Limit: < 1.5 ppm

Includes Audited Products: Rectal or vaginal administration.

Process Validation

You may Process Validate for Heavy Metals.

  • Time frame to complete: minimum of 4 weeks with a maximum of 8 weeks.
  • Every production batch in that time frame must be tested.
  • Process Validation is effective for one year.
  • Ongoing Testing: once process validated, you must submit one Production Batch every 30 days.

For an indepth understanding of how Process Validation for Contaminants works, please view our tutorial.

View our Process Validation Tutorial