PharmaState Is Official Media Partner For DUPHAT 2022. Click the banner to explore more...spot_imgspot_imgspot_img

STANDARD DEVIATION PREDICTION INTERVAL (SDPI)  

-

 

Since uniformity is of primary interest in powder blend validation and because of a concern that a constant sampling error can occur, one approach is to base the criteria only on variability. The SDPI allows one to predict, from a sample of size n and with a specified level of assurance, an upper bound on the standard deviation of a future sample of size m from the same population. This approach is recommended in the PDA paper on blend uniformity.

By setting the future sample size m to 10, which is the stage-1 sample size for the USP 25 content uniformity test, and by requiring that the upper bound on the standard deviation of a future sample of size 10 be less than 6.0%, which is the USP 25 stage-1 RSD requirement, the SDPI approach can be tied to the USP 25 content uniformity test. The SDPI equation in Sec. II can be rearranged to obtain the following equation:-

 

                                  scr = sm/[F1−α,m−1,n−1]1/2

where

n = size of current sample

scr = critical standard deviation

sm = upper bound of a future sample of size m

1 − α = confidence level (e.g., 0.90)

F = critical F value

 

Scr becomes the maximum acceptable sample standard deviation to meet the acceptance criteria. If the sample standard deviation Sn is less than Scr, then we are guaranteed, with a minimum assurance of 100(1 − α)%, that the upper prediction bound for a future sample of size 10 will not be greater than 6.0% of the target concentration.

 

PharmaState Blog
This is a platform for people working in the pharmaceuticals industry for Discussions, Jobs, News updates, Professional Profile display space and company business pages. PharmaState DNA is having four pillars: Quality, Transparency, Innovation & Benchmarks.

Share this article

Recent posts

Popular categories

Leave a Reply

Recent comments

Business Alnavedic on History of Indian Pharma Industry
Ahmed Mohamed Elkhodragy on MACO Calculation
Jennifer Osunde on DEFECTS IN UNCOATED TABLETS
Vinod on DEVIATION
Rajib ghose on TOOLING FOR TABLETING
K. SRinivasula Reddy on Quality Agreements – PART 2
Sunil Kumar M on SITE ACCEPTANCE TEST (SAT)
Khalid on IQ Protocol
Khalid on IQ Protocol
Nagabooshanam on Calibration of Reactor
PharmaState Blog on SOP for Sampling
Swapnil Khodake on TOOLING FOR TABLETING
%d bloggers like this: