Trace Element Testing-CTi CENTRE TESTING INTERNATIONAL

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Trace Element Testing

CTI offers trace element testing for raw and auxiliary materials. Analytical method development meets the requirements of ICH Q14 guidelines; analytical method validation meets the requirements of ICHQ2(R2) guidelines, USP<1225>, <233> General Principles, ChP<9101> General Principles, and other pharmacopoeia analytical method validation guidelines.

Consulting quotation

Service Background

Since ICH Q3D came into effect, the industry has been paying increasing attention to the detection of trace elements in products. Elemental impurities do not have a positive effect on patient care and therefore need to be controlled to an acceptable level, i.e. below the PDE value.

Applicable Products

Applicable to APIs, excipients, finished drugs, biopharmaceuticals (drug products containing purified proteins and peptides), etc.

Service Content

Evaluate the types of elements to be tested based on the route of administration of the finished drug product, the classification of the elements, and whether or not they are artificially added. Calculate the limits of the elements in the product, taking into account the dosage of the finished drug product and the PDE of the element. Analytical method development and validation using ICP-MS.

Featured Services

Scanning or quantitative analysis of 24 elements specified in ICH Q3D is available.

24 Element Limits and Routes of Administration

Element	Type	If added intentionally	If not intentionally added
Element	Type	If added intentionally	OralOral	Not via intestinesNot via intestines	Inhalation
Cd	1	Yes	Yes	Yes	Yes
Pb	1	Yes	Yes	Yes	Yes
As	1	Yes	Yes	Yes	Yes
Hg	1	Yes	Yes	Yes	Yes
Co	2A	Yes	Yes	Yes	Yes
V	2A	Yes	Yes	Yes	Yes
Ni	2A	Yes	Yes	Yes	Yes
Tl	2B	Yes	No	No	No
Au	2B	Yes	No	No	No
Pd	2B	Yes	No	No	No
Ir	2B	Yes	No	No	No
Os	2B	Yes	No	No	No
Rh	2B	Yes	No	No	No
Ru	2B	Yes	No	No	No
Se	2B	Yes	No	No	No
Ag	2B	Yes	No	No	No
Pt	2B	Yes	No	No	No
Li	3	Yes	No	Yes	Yes
Sb	3	Yes	No	Yes	Yes
Ba	3	Yes	No	No	Yes
Mo	3	Yes	No	No	Yes
Cu	3	Yes	No	Yes	Yes
Sn	3	Yes	No	No	Yes
Cr	3	Yes	No	No	Yes

PDE for impurities of the 24 elements

Element	Type	Oral PDE (μg/day)	No enteral PDE (μg/day)	Inhaled PDE (μg/day)
Cd	1	5	2	3
Pb	1	5	5	5
As	1	15	15	2
Hg	1	30	3	1
Co	2A	50	5	3
V	2A	100	10	1
Ni	2A	200	20	6
Tl	2B	8	8	8
Au	2B	300	300	3
Pd	2B	100	10	1
Ir	2B	100	10	1
Os	2B	100	10	1
Rh	2B	100	10	1
Ru	2B	100	10	1
Se	2B	150	80	130
Ag	2B	150	15	7
Pt	2B	100	10	1
Li	3	550	250	25
Sb	3	1200	90	20
Ba	3	1400	700	300
Mo	3	3000	1500	10
Cu	3	3000	300	30
Sn	3	6000	600	60
Cr	3	11000	1100	3