A stress Study for Stability Guidelines is provided here for Pharmaceuticals Professionals. Stress Study is also calling as Forced Degradation (/Stress Testing).
What is Stress Study
Stress testing of the drug substance (API) will help to identify the likely degradation products. This will help to establish the degradation pathways and the intrinsic stability of the molecule. Hence, the Forced degradation study is important to validate the stability indicating the power of the analytical procedures used.
Procedure for Stress Study
R&D personnel shall be provided a sufficient quantity of samples to AR&D for conducting the study after getting the final API from the feasibility process or optimized process at the R&D or CPP process.
The stress stability shall be studied for non-micronized grade and micronized grade material and R&D shall provide the material to AR&D.
The Stress stability shall be studied at below mentioned conditions for both non-micronized grade and micronized grade samples.
Sampling and packing conditions
Take 4-5 g of the sample in a Petri dish and close the paraffin film and keep it under the below conditions.
Note: Ensure to avoid cross-contamination during the packing and storage of the samples.
Table – Storage conditions and testing frequency
| S.No. | Stability Study Condition | Storage Conditions | Testing frequency |
| 01 | Thermal Stress | 90°c + 2°c | Initial, 3rd day, and 10th day. |
| 02 | Photo Stress | 254 nm/365 nm | Initial, 3rd day, and 10th day. |
| 03 | Accelerated Stress | 40°c + 2°c 75% + 5%RH | Initial, 3rd day, and 10th day. |
| 04 | Compressed Stress | 2000 kg/cm2 | Initial and after 1Hr compressed. |
Analytical Test Parameters for Stress study
The following tests shall consider as part of Stress Stability Studies (but not limited to).
- Description
- IR
- Water content
- Related substances by HPLC
- XRD
- DSC
If any significant degradation is observed on 3 rd day, further study need not be carried out for that particular condition sample.
Ex: In the 90°C studies, the 3 rd day sample undergoes significant degradation than the 10th-day station sample need not be analyzed.
AR&D shall enter the results in the datasheet after the analysis is completed
The 10th-day samples shall be stored at normal conditions and shall be analyzed after finalizing the spec and MOA for API.
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