ICH-Q3D Elemental impurities in solid pharmaceutical substances

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

Package info

Price: 4 885 SEK / sample
Std. response time: 10 work days
Fastest response time: 1 work day
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.