Category: Pharmaceutical Blog

read more about Stability testing requirements for Pharmaceuticals and Medical Devices

Stability testing requirements for Pharmaceuticals and Medical Devices

Development phase Accelerated stability tests provide a means of comparing alternative formula-dons, packaging materials, and/or manufacturing processes in short-term experiments. As soon as the final formulation and manufacturing process have been established, the manufacturer carries out a series of accelerated stability tests which will enable the stability of the drug product or medical device to … Continued



read more about Storage of Reference and Retain Pharmacuetical Samples

Storage of Reference and Retain Pharmacuetical Samples

Definitions Reference samples are retained to fulfil two purposes; firstly to provide a sample for analytical testing and secondly to provide a specimen of the fully finished product.  They serve as a record of the batch of finished product or starting material and can be assessed in the event of, for example, a dosage form … Continued


read more about ICH Requirements for Pharmaceutical

ICH Requirements for Pharmaceutical

ICH refers to The International Council for Harmonisation, which regulates the Technical Requirements for Pharmaceuticals for Human Use. The ICH was founded in 1990 with the aim to internationally harmonise the regulatory authorities and pharmaceutical industries of Europe, Japan and the United States. From its inception, the ICH has contributed to advancing public health through: Developing and … Continued



read more about Thermal Cycling / Freeze Thaw Study
Time V Temperature

Thermal Cycling / Freeze Thaw Study

Thermal Cycling gives an indication as to how a product will react to adverse conditions, usually encountered during transportation.




read more about Need Ultra Low (-80) Cold Storage?
Need Ultra Low (-80) Cold Storage?

Need Ultra Low (-80) Cold Storage?

If you have a requirement for ultra low storage (-80 deg), talk to Q1 Scientific today. Samples can be returned to you at controlled temperatures.


read more about Are your Photostability Testing Requirements up to date?
Are your Photostability Testing Requirements up to date?

Are your Photostability Testing Requirements up to date?

All companies developing or manufacturing pharmaceutical drugs, require a robust photostability testing process to ensure product quality and regulatory compliance. Inadequate testing can result in costly delays and lost revenue.