Interested to Buy Any Domain ? << Click Here >> for more details...
what is the Bracketing & Matrixing.
- 8 Answers
- 45182 Views
- Dr Reddys, Ranbaxy, I also Faced
- E-Mail Answers
Answer Posted / deepak kumar
Bracketing :
The design of a stability schedule such that only samples
on the extremes of certain design
factors, e.g., strength, package size, are tested at all
time points as in a full design. The design
assumes that the stability of any intermediate levels is
represented by the stability of the
extremes tested. Where a range of strengths is to be
tested, bracketing is applicable if the
strengths are identical or very closely related in
composition (e.g., for a tablet range made
with different compression weights of a similar basic
granulation, or a capsule range made by
filling different plug fill weights of the same basic
composition into different size capsule
shells). Bracketing can be applied to different container
sizes or different fills in the same
container closure system.
Matrixing :
The design of a stability schedule such that a selected
subset of the total number of possible
samples for all factor combinations is tested at a
specified time point. At a subsequent time
point, another subset of samples for all factor
combinations is tested. The design assumes that
the stability of each subset of samples tested represents
the stability of all samples at a given
time point. The differences in the samples for the same
drug product should be identified as,
for example, covering different batches, different
strengths, different sizes of the same
container closure system, and, possibly in some cases,
different container closure systems.
| Is This Answer Correct ? | 0 Yes | 0 No |
Post New Answer View All Answers
How to know the estimated LOQ concentration in ppm
How can we confirm the HPLC column is end-capped or not? Is it possible to identify by physical appearance?
how can give the expiry period and restadardisation of volumetric solution
If change in specification which parameter require to do for validation? if change in chromtographic condition then which parameter? if api change then which parameter? if change composition then which parameter? if old method not work out then whicj parameter? if additional one impurity added then which parameter of validation require to do on above each conditions? elaborate separately
how you establish the LOQ?
what is procedure of actual procedure for registration of drug?
when we talk about change in entropy we consider total entropy means of surround +entropy of system but when we talk about change in Gibss free energy we consider entropy of system.explain with reason.
What is the difference between purge septum flow and column flow in gas chromatography?
what is mean by dissolution hydrodynamics?
What is the formula for relative diffrence for standard solution in solution stability in validation?
Is it nessesary all multimedia dissolution require descriminatory?
WHAT IS THE USE OF STARTER ?????????
what is mean by peak intigrity?
Qc interview questions
What is the accrptance criteria in RSD for RS method precision on basis of impurity percentages?
