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Elemental Impurities in Pharmaceutical Products

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January 1, 2018 Implementation Of USP 232 and 233

USP 232 – “Permitted Daily Exposure Limits For Elemental Impurities”

January 1, 2018, United States Pharmacopeia (USP) requires all Pharmaceutical Manufactures to comply with the “Permitted Daily Exposure Limits For Elemental Impurities For Drug Products” as detailed in USP Chapter 232.  These limits specify the maximum allowable toxic metals that can reside in Pharmaceutical Ingredients and Products.

USP 233 – Elemental Impurity Analytical Method Validation And Procedures

As a requirement to meet the USP 232 Permitted Daily Exposure Limits Of Elemental Impurities in Pharmaceutical Ingredients and Products, USP requires that each product undergo an analytical method validation that demonstrates that the analysis method used to analyze for the elemental impurities can precisely and accurately measure each of the elements required for compliance.

Eurofins Frontier Global Sciences: Path To USP 232 and USP 233 Compliance

Eurofins Frontier Global Sciences has the laboratory facilities, instrumentation, cGMP and GcLP Compliant Laboratory and staff to help with your method validation and ongoing testing:

Contact Robert Brunette at Eurofins Frontier Global Sciences and get started on your path to demonstrated compliance.

 * Table V.1 (5.1): Elements To Be Considered In The Risk Assessment

      Oral Parenteral Inhalation
Cadmium 1 Yes Yes Yes Yes
Lead 1 Yes Yes Yes Yes
Arsenic 1 Yes yes Yes Yes
Mercury 1 Yes Yes Yes Yes
Cobalt 2A Yes Yes Yes Yes
Vanadium 2A Yes Yes Yes Yes
Nickel 2A Yes Yes Yes Yes
Thallium 2B Yes No No No
Gold 2B Yes No No No
Palladium 2B Yes No No No
Iridium 2B Yes No No No
Osmium 2B Yes No No No
Rhodium 2B Yes No No No
Ruthenium 2B Yes No No No
Selenium 2B Yes No No No
Silver 2B Yes No No No
Platinum 2B Yes No No No
Lithium 3 Yes No Yes Yes
Antimony 3 Yes No Yes Yes
Barium 3 Yes No No Yes
Molybdenum 3 Yes No No Yes
Copper 3 Yes No Yes Yes
Tin 3 Yes No No Yes
Chromium 3 Yes No No Yes
* Table Recreated From FDA "Q3D Elemental Impurities Guidance For Industry"  September 2015 ICH.

 

* Table A.2.1: Permitted Daily Exposures for Elemental Impurities

Element ICH Class Oral PDE (ug/day) Parenteral Daily PDE (ug/day) Inhalation PDE (ug/day)
Cadmium 1 5 2 2
Lead 1 5 5 5
Arsenic 1 15 15 2
Mercury 1 30 3 1
Cobalt 2A 50 5 3
Vanadium 2A 100 10 1
Nickel 2A 200 20 5
Thallium 2B 8 8 8
Gold 2B 100 100 1
Palladium 2B 100 10 1
Iridium 2B 100 10 1
Osmium 2B 100 10 1
Rhodium 2B 100 10 1
Ruthenium 2B 100 10 1
Selenium 2B 150 80 130
Silver 2B 150 10 7
Platinum 2B 100 10 1
Lithium 3 550 250 25
Antimony 3 1200 90 20
Barium 3 1400 700 300
Molybdenum 3 3000 1500 10
Copper 3 3000 300 30
Tin 3 6000 600 60
Chromium 3 11000 1100 3
* Table Recreated From FDA "Q3D Elemental Impurities Guidance For Industry"  September 2015 ICH.