Answer Posted / patel riken

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.

thanks

what are the standard methods for HPLC?

2730

---

why we are using benzene, anyline in acetic anhdride assay titration method?

2062

---

what is the principle of UV Vis spectroscopy, AAS, ICP OES,ICPAES, ICP-MS and FTIR

9177

---

From where require to take the RLD sample?

703

---

cefoperozone and sulbactam inj. hplc test method

2639

---

Please tell me about the pH of Polycaboxylic ether is it in the 5-6 range ever or more than 6

2550

---

why are measure gas flow " ml " in Gas chromatography

1590

---

if tech transfer fails whay require to do?

769

---

how you start RS method development when for new product?

657

---

[3/28, 20:52] Manoj P Venkatpurwar: how many impurities require to inject in assay specificity that how we can find out? and in Rs also how?

743

---

how to decide for one product require water content or LOD?

721

---

what is definition of validation? which components are followed give detail?

2284

---

What is third generation HPLC Columns?

1927

---

IS THERE ANY EQUIPMENT TO CHECK AND CALCULATE THE POLARITY OF A LIQUID?

2389

---

in stress study if your api not soluble in hcl naoh h2o2 then what require to do?

789

---