Irvine Pharmaceutical Services | Extractables and Leachables

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USP UPDATES AND EVENTS

Elemental Impurities

Let Irvine help identify the levels of metal impurities in your drug products

USP has proposed two new general chapters to replace Heavy Metals <231> ([PF 36(1), Jan-Feb 2010]):

Elemental Impurities - Limits <232>
Elemental Impurities - Procedures <233>

Irvine leads the industry as an active participant in collaborative studies to develop methodologies to support the determination and control of elemental impurities. Irvine has the technical expertise and state-of-the-art resources to provide complete solutions for meeting these new requirements as they become effective.

Timely Analysis with Modern, Precise Instrumentation:

ICP-OES
ICP-MS
Graphite AA
Flame AA
Cold Vapor AA

Trust the industry leader to detect and control the proposed limits of Class 1 and Class 2 impurities:

Element	Oral Component Limit (µg/g) per 10-g Dose	Oral Daily Dose PDE (µg/day)	Parenteral Component Limit (µg/g) per 10-g Dose	Parenteral Daily Dose PDE (µg/day)
Arsenic	1.5	15	0.15	1.5
Cadmium	0.5	5	0.05	0.5
Lead	1	10	0.1	1
Mercury	1.5	15	0.15	1.5
Chromium	25	250	2.5	25
Copper	250	2500	25	250
Manganese	250	2500	25	250
Molybdenum	25	250	2.5	25
Nickel	25	250	2.5	25
Palladium	10	100	1.0	10
Platinum	10	100	1.0	10
Vanadium	25	250	2.5	25
Osmium	10 (Combination not to exceed)	100 (Combination not to exceed)	1.0 (Combination not to exceed)	10 (Combination not to exceed)
Rhodium
Ruthenium
Iridium

REQUEST A PROPOSAL TODAY!