Extractables & Leachables (E&L) Testing

Find out what your container, closure or single-use system releases into the drug, and whether it matters for patient safety.

4.9/5Rated by 28 clients

How Extractables & Leachables (E&L) Testing works

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

Each step explained

Trusted by Leading Brands Across the Globe

Overview of Extractables & Leachables (E&L) Testing

Tested by: NABL-accredited partner lab
Regulation: USP <1663> & <1664>
Typical turnaround: 6–12 weeks
Sample needed: Components and filled product

Plastics, rubbers, adhesives and inks can release chemicals into a medicine. Extractables are what comes out of a material under aggressive laboratory conditions; leachables are what actually migrates into the product during storage. Regulators expect E&L data especially for injectables, inhalation, ophthalmic and biological products, where the route of exposure and contact time make the risk highest.

Studies follow USP <1663> and <1664> and use GC-MS, LC-MS and ICP-MS to screen organic and elemental compounds, with results assessed by a toxicologist against safety thresholds. Food packaging has its own route; see food contact migration testing.

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: Components and filled product
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 Extractables & Leachables (E&L) Testing

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
Controlled extraction study	Solvents, time and temperature
Volatile and semi-volatile organics	GC-MS screening
Non-volatile organics	LC-MS screening
Elemental extractables	ICP-MS
Leachables in product over shelf life	Targeted testing during stability
Toxicological risk assessment	Against safety thresholds

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 oral tablets in blister packs need E&L studies?

Usually a much smaller study, if any. Solid oral products in standard pharmaceutical-grade packaging are low risk. E&L effort concentrates on liquids, injectables and inhaled products.

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
Get Started with the Right Expert
Testing, certification and registrations handled by one team

+91 99991 18039 WhatsApp us

Get a free assessment