what is Out of specification (OOS)?

 1.What is Out of specification (OOS)?

Defined as those results of in process or finished product testing that does not comply with the pre-determined acceptance established in drug applications, drug master files (DMFs), official compendia, or by the manufacturer.

2.What is Out of trend (OOT)?

result that does not follow the expected trend, either in comparison with previous results with other stability batches or with respect to previous results collected during a stability study.

3.What is Bioassay?

is an analytical method to determine the concentration or potency of a substance by its effect on living cells or tissues.

4.What is Biomarker?

is defined as a measurable indicator that can be used to a particular disease state or some other biological state of an organism.

5.What is Precision?

The precision of an analytical procedure refers to the closeness of agreement between a series of measurements obtained from multiple sampling of the same homogeneous sample under the prescribed conditions.

6.What is Robustness?

refer to the ability of an analytical method to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage.

7.What is TOC?

Total organic carbon (TOC) is a measure of the total amount is of carbon bound in an organic compound and is often used as a non-specific indicator of water quality or cleanliness of pharmaceutical manufacturing equipment.

8.How does high performance liquid chromatography (HPLC) work?

High-performance liquid chromatography (sometimes referred to as high-pressure liquid chromatography), HPLC, is a chromatographic technique that can separate a mixture of compounds and is used in biochemistry and analytical chemistry to identify, quantify and purify the individual components of the mixture. HPLC typically utilizes different types of stationary phases contained in columns, a pump that moves the mobile phase and sample components through the column, and a detector to provide a characteristic retention time for the analyte and an area count reflecting the amount of analyte passing through the detector.

9. What is the Ultraviolet-Visible (UV) spectrophotometer application?

Ultraviolet–visible spectroscopy or ultraviolet-visible spectrophotometer (UV-Vis or UV/Vis) refers to absorption spectroscopy or reflectance spectroscopy in the ultraviolet-visible spectral region. This means it uses light in the visible and adjacent (near-UV and near-infrared (NIR)) ranges. UV/Vis spectroscopy is routinely used in analytical chemistry for the quantitative determination of different analyses, such as transition metal ions, highly conjugated organic compounds, and biological macromolecules. Determination is usually carried out in solutions.