ICH-Q3D Elemental impurities in solid pharmaceutical substances

Substance: Report limit:
Class 1:
Cd, cadmium
Pb, lead
As, arsenic
Hg, mercury
Class 2A:
Co, cobalt
V, vanadium
Ni, nickel
Class 2B:
Tl, thallium
Au, gold
Pd, palladium
Ir, iridium
Os, osmium
Rh, rhodium
Ru, ruthenium
Se, selenium
Ag, silver
Pt, platinum
Class 3:
Li, lithium
Sb, antimony
Ba, barium
Mo, molybdenum
Cu, copper
Sn, tin
Cr, chromium

Package info

Price: 4 885 SEK / sample
Std. response time: 10 work days
Fastest response time: 1 work day
Discount group: 5
Sample type: Pharmaceuticals
Analysis type: Elements
Sample amount: 0.5-1 g
Method: Analysis with ICP-SFMS after three separate digestion steps
Express: Yes, Expresstariff 1: SameDay +350%; Q07 +400%; Q12 300%; Q17 +200%; 1 day +100%; 2 days +75%; 3 days +40%; 4 days +30%; 5 days +20%
Accreditation: No
Remarks: The range of elements can be adapted as required. Please contact ALS Scandinavia for further information.
Additional cost for analysis according to GMP: + 50%, but not less than 750 SEK/sample
ALS Scandinavia AB has no generally validated method but offer method validations on request.
Reporting limits vary depending on sample matrix.