Elemental Impurity Analysis (ICH Q3D)

We provide elemental impurity evaluation services for pharmaceuticals in accordance with the ICH Q3D guideline*1. Please feel free to contact us.

• We develop an analytical test methods and control the thresholds of elemental impurities based on sample information provided by our clients, and then we determine the amounts of impurities.
• We also analyze hard-to-decompose samples including skin formulations and parenteral infusion preparations with large daily doses, using a pressure microwave pretreatment device (Ultra WAVE).
• High potency substances (OEL > 0.1 μg/m3), narcotics and stimulants can be handled at our laboratories.
• We conform to the Japan's Reliability Criteria*2, and GMP (Japan, the USA, and Europe).
• We have abundant experience in FDA inspections, PMDA inspections and audits by clients worldwide, including Japan.

• Measurements are performed using our analytical instruments that ensure data integrity.
• We manage the environment of the elemental impurity analysis room with a cleanliness monitoring system, which reduces the risk of contamination during testing and enables rapid root cause investigation when an abnormal measurement result is obtained.

24 elemental impurities specified in the ICH Q3D guideline/Other elemental impurities requested by our clients (e.g., Na, Mg, Al, P, Fe, Zn)

Screening test, analytical method development, analytical method validation, sample measurement (quantitative test and limit test)
We also offer packaged services covering everything from analytical method development to analytical method validation and sample measurement.
We can also undertake elemental impurity testing as part of quality, stability and release testing.

Drug substances, intermediates, drug products (oral formulations, injections, parenteral infusion preparations, inhalants, skin formulations), nucleic acids, peptides, biologics, additives, raw materials, packaging containers, etc.

• We have extensive experience in the measurement of more than 500 drug products from over 100 clients.
• We have given numerous seminars, such as exhibitions, in-house seminars and open seminars hosted by seminar companies, etc.

• *
  1 Pharmaceuticals and Medical Devices Agency, "ICH-Q3 Impurities" 　(accessed 2025.12.10)
• *
  2 Article 43 of Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices