Elemental Impurities Testing (ICH Q3D)

Complete the ICH Q3D risk assessment for your drug product and back it with validated ICP-MS data.

How Elemental Impurities Testing (ICH Q3D) works

1Assessment of requirement
2Sample collection
3Right lab assigned
4Testing
5Test report

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Overview of Elemental Impurities Testing (ICH Q3D)

Tested by: NABL-accredited partner lab
Regulation: ICH Q3D & USP <232>/<233>
Typical turnaround: 7–10 working days
Sample needed: 10–20 g or units per batch

ICH Q3D replaced the old heavy-metals colour test with limits for individual elements, expressed as a permitted daily exposure (PDE) that depends on whether the product is oral, parenteral or inhaled. Elements are grouped by toxicity: class 1 (cadmium, lead, arsenic, mercury) must always be considered, while others such as nickel, cobalt, vanadium and catalysts like palladium and platinum depend on their likely sources.

The guideline asks for a risk assessment covering the API, excipients, water, manufacturing equipment and packaging. Where the assessment cannot rule out an element, batches are tested by ICP-MS or ICP-OES using a method validated to USP <233>. Regulated markets, including the US and Europe, expect this in every dossier. For food products, see heavy metals testing in food.

What we do for you

Lab and parameter list chosen for your purpose: licence, export, buyer or internal QC
Sampling guidance, and pickup or on-site sampling where needed
One contact who follows up with the lab until the report is issued
Report explained in plain language, with next steps if a result fails

What to send

The lab confirms the exact quantity and packing for your product when we book the test.

Sample

Quantity: 10–20 g or units per batch
Sealed and labelled with the product name, batch number and date
Packed so that it cannot leak or be contaminated in transit

Details to share

Product name, composition and licence category (AYUSH, CDSCO or FSSAI)
Label and claims
The pharmacopoeia, standard or buyer specification to test against
Purpose: licence, tender, export or internal QC

How we handle Elemental Impurities Testing (ICH Q3D)

1
Assessment of requirement
We confirm the standard, the list of tests and how many samples your product needs.
2
Sample collection
We collect the samples from your factory or warehouse, or tell you exactly where to send them.
3
Right lab assigned
We choose an accredited lab (NABL, BIS-recognised or ILAC) that covers your standard and can start soonest.
4
Testing
The lab tests your samples against the standard. We follow up and tell you at once if a test fails.
5
Test report
You receive the signed test report, ready to use for BIS, WPC, CE or your buyer.

What the lab tests

Parameter	Why it is checked
Class 1: Cd, Pb, As, Hg	Always assessed
Class 2A: Co, V, Ni	High natural abundance
Catalysts: Pd, Pt, Ru, Rh and others	Residues from synthesis
Route-specific PDEs	Oral, parenteral, inhalation
Method validation (USP <233>)	Accuracy, precision, specificity

The final list depends on your product, its standard and the purpose of testing. We confirm it with you before the sample goes to the lab.

Frequently asked questions

Do all batches need testing?

Not usually. If the risk assessment and data from a few batches show elements are consistently below 30 per cent of the PDE, routine testing may not be needed. The assessment must be kept up to date when suppliers change.

Will regulators and buyers accept the report?

Testing is done in NABL-accredited labs, and where a licence requires it, in labs approved under the Drugs and Cosmetics Rules. We confirm the requirement for your licence, tender or buyer before testing.

Who carries out the testing?

Instacertify’s partner laboratories, accredited by NABL to ISO/IEC 17025 for the parameters on your report. We choose the lab, arrange the sample, follow up until the report is issued and explain the results to you.

What our clients say

“Instacertify helped us get BIS CRS certification for our entire product range within just 6 weeks. Their team handled everything from documentation to lab coordination. Highly professional service.”

Akash GuptaBIS CRS · Electronics brand

“They handled complete certification for us, from ISO 9001 to BIS for PVC cables and plugs. Thorough, professional and always available — they knew what needed to be done and when.”

Shivank VishnoiISO 9001 & BIS · Cables

“Getting TEC approvals for our access-control products seemed confusing and complex, but Instacertify made it simple.”

Jiten ShahTEC approval · Access control

Not sure which certification you need?

Send us the product name and the countries you sell in. A specialist replies with the standards that apply, the documents to prepare, the lab cost and the timeline. The assessment is free.

The list of approvals comes to you in writing
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