Pharmaceutical Stability Studies

Set a shelf life you can defend, with stability data generated under the conditions your product will actually face.

How Pharmaceutical Stability Studies works

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

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Overview of Pharmaceutical Stability Studies

Tested by: NABL-accredited partner lab
Regulation: ICH Q1A(R2) & Q1B
Typical turnaround: 6 months to 3 years
Sample needed: Batches in final packs

Stability studies show how a product’s quality changes over time under temperature, humidity and light, and set its shelf life and storage instructions. ICH Q1A(R2) sets storage conditions by climatic zone. India falls in zone IVb (hot and very humid), so CDSCO expects long-term data at 30 °C and 75 per cent relative humidity, with accelerated studies at 40 °C and 75 per cent RH for six months. Photostability follows ICH Q1B.

Samples are stored in qualified chambers and pulled at fixed points, typically 0, 3, 6, 9, 12, 18, 24 and 36 months, for assay, impurities, dissolution and appearance. The same approach is used for nutraceuticals and cosmetics, though their requirements are less prescriptive. For packaged food, see shelf-life 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: Batches in final packs
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 Pharmaceutical Stability Studies

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
Long-term: 30 °C / 75% RH	Zone IVb, the Indian condition
Accelerated: 40 °C / 75% RH	Six-month predictive study
Intermediate and refrigerated conditions	Where the product needs them
Photostability (ICH Q1B)	Effect of light
Pull-point testing	Assay, impurities, dissolution, appearance

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

Can accelerated data alone support a shelf life?

It can support a provisional shelf life for a new product, which must then be confirmed with long-term data. Regulators expect long-term studies on the commercial packs to continue.

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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