About Me


Welcome,


Myself Biren Ghodasara, I have more than 10 years experience in pharmaceutical industry in different area like Pharmaceutical industry Quality control Quality assurance, local pharmacy, Marketing chain.


Objective of creating the blog to the guide Quality control against compliance and productivity. 


This blog open discussion forum for the different topic to the pharmaceutical industry directly and indirectly related to the Quality Control.

Popular posts from this blog

What is Retention time?

Image
Retention time (RT) is a measure of the time taken for a solute to pass through a chromatography column. Retention time (RT) is calculated as the time from injection to detection. The RT for a compound is not fixed as many factors can influence it even if the same instrument and column are used.  These include: The flow rate Temperature differences in the oven and column Column degradation Column length What is RRT?
Read more

Establishment of expiry dating for chemicals, reagents, solutions, and solvents?

Image
Laboratory “reagents, and standard solutions,” as referenced in the CGMP regulations at 211.194, includes laboratory chemicals such as solvents (including mobile phases), dry chemicals (salts, primary standards, etc.), and solutions (buffers, acids/bases, quantitative analytical preparations, etc.), whether purchased or prepared in-house. Laboratory reagents and solutions are used in analytical tests of components, in-process materials, and finished products. If the purchased laboratory reagent or solution includes a manufacturer’s suggested "use by" or expiry date, that date should be followed. For purchased laboratory reagents and solutions without a "use by" or expiry date, FDA would expect that an assessment be conducted (literature review may be acceptable) of that specific chemical's or chemical family's stability and that an appropriate "use by" or expiry date be determined. For in-house prepared solutions, such as mobi...
Read more

Relation between Resolution and Peak separation?

Image
The resolution is represented as a numeric value, such as 0.8, 1.0, or 3.0. But what is the relationship between the number representing the resolution and the actual peak separation?  At a resolution of 1.0, if the two peaks are assumed to have a Gaussian distribution and have the same peak height and peak width, then the difference in retention time from equation  become 1.0W, or 1.0 × 4σ = 4 σ.  In the case of a Gaussian distribution, 4 σ encompasses 95.4 %, such that the peaks overlap by 2.3 % ((100 % - 95.4 %)/2).  This indicates that 2.3 % of the peak intrudes into the other peak from a perpendicular line drawn in the trough.  Similarly, a resolution of 1.5 indicates a difference in retention time of 1.5× 4σ = 6σ, which corresponds to an overlap of 0.15 % ((100 % - 99.7 %)/2).
Read more