by maheshbhuva | Apr 30, 2025 | Analytical Chemistry, Quality control (QC), stability, wet lab
1. Charging Samples to a Stability Study (Initiation):In the pharmaceutical industry, “charging” samples to a stability study refers to the process of formally placing representative samples of a drug substance or drug product into controlled storage...
by maheshbhuva | Jun 6, 2023 | Analytical Chemistry, Job in pharmaceutical companies, stability
In the pharmaceutical industry, a “finished product retest” refers to the process of evaluating a sample from a previously manufactured and packaged pharmaceutical product to assess its quality, safety, and efficacy. The purpose of the retest is to ensure...
by maheshbhuva | May 22, 2023 | stability
Accelerated testing Increase the rate of chemical or physical change of drug product by using exaggerated condition as part of formal stability study. Intermediate testing conducted as at 30°C/65% designed to moderately increase the rate of chemical or physical...
by maheshbhuva | May 20, 2023 | stability
Here both are the different Accelerated stability testing only 40°C/75 RH Study here time period are 1,3,6,12 Each batch perform Accelerated stability study Here we have to seen that naturally degraded drug product which is covered  According to WHO guidelines...
by maheshbhuva | May 19, 2023 | Analytical Chemistry, stability
Chemical: Each API (active ingredient retains its chemical integrity and labeled potency within the specified limit. Physical: the physical stability properties includes appearance, palatability, uniformity, dissolution and suspend ability are retained....
