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Stability studies of a product are the study of the capability of a particular formulation, in a specific container /Closure system to remain within its physical, Chemical, and Microbiological specifications throughout its predetermined shelf life under specified storage conditions. Normally it is done to establish shelf life or expiry date for the products.

Physical, Chemical & Microbiological parameters are tested as per customer requirements at each specified study.
We shall design plans & Protocols for Stability Studies according to the Current Regulatory Requirements for your products as per ICH guidelines & ASEAN.
Normally two types of stability studies are being carried out as below;

 

Sr. #

Type

Duration

Storage condition

Testing frequency

1

Accelerated Conditions

6 Months

Temperature = 40 ± 2oC
Humidity = 75 ± 5%

To, T3, T6

2

Long Term Study
(Room Conditions)

As per shelf Life

Temperature = 30 ± 2oC
Humidity = 75 ± 5 %.

First Year( Initial) Testing
To, T3, T6, T9, T12,

Second-year
Every six months T18, T24

Third Year
Annually T36

However, storage conditions and testing frequency can be changed as per customer requirements,


Qarshi Research International is working to launch various training courses focusing on the technical fields of testing and calibration.

We are also working to be the first accredited organization in Pakistan that will provide Certified Reference Material (CRM) in various food matrices.

To cater the need of our valued export-oriented customer under one window operation, we will also provide accredited inspection services in addition to accredited testing.

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