Interested to Buy Any Domain ? << Click Here >> for more details...
What are the significance of MKT in stability study.
- 1 Answers
- 7430 Views
- Alembic, I also Faced
- E-Mail Answers
Answer Posted / navin patel
MKT or Mean Kinetic Temperature provides a better
representation of the effects of temperature change on
sensitive materials such as pharmaceuticals during storage
and distribution. MKT can be calculated from a series of
temperatures. It differs from arithmetic mean in that
higher temperatures are given greater weight in computing
the average.
MKT calculation gives increased weighting to higher
temperature excursions than normal arithmetic methods,
recognizing the accelerated rate of thermal degradation of
materials at higher temperatures. It expresses the
cumulative thermal stress experienced by a product at
varying temperatures during storage and distribution.
As defined by the USP, it is a “single calculated
temperature at which the total amount of degradation over a
particular period is equal to the sum of the individual
degradations that would occur at various temperatures”.
As defined by ICH, “A single derived temperature that, if
maintained over a defined period of time, affords the same
thermal challenge to a drug substance or drug product as
would be experienced over a range of both higher and lower
temperatures for an equivalent defined period.”
The mean kinetic temperature is higher than the arithmetic
mean temperature and takes into account the Arrhenius
equation.
| Is This Answer Correct ? | 8 Yes | 0 No |
Post New Answer View All Answers
How to do IR test of hydroscopic materials
pls send me last two years solved papers of health & malaria inspector to kumar.santosh087@yahoo.com
Anyone have any idea when to conduct Uniformity of Weight (UOW) and when need to conduct Uniformity of Dosage Units (UOD) or when need both? I read BP it only said if average weight < or = 0.04g then just conduct UOD, no need UOW. Under UOD section, it doesnt say when need to conduct UOD but just said UOD got two type, one is Mass Variation (MV), another is Content Uniformity (CU) and under what conditions to conduct them. For USP, no UOW section, only got UOD section.
How to preform dissolution profiling
please explain the job responsibilities of quality assurance..
why you are become a medical representative
what is factor?
Iam a B.PHARMA GRADUATE from DELHI UNIVERSITY and I am looking forward for DRUG INSPECTOR EXAM..kindly mail me any ques papaers reg the same...
how many clauses are there in iso? give me the clauses details?
from hplc chromatogram how can we say that calibration is needed now?
Caffeine standard is recommended by the monograph for HPLC wavelength accuracy calibration. It is covered range of 205 to 273 only.If the method have wavelength beyond the range, then how it supports for instrument performance?
WHAT IS MEANING OF DEAIATION WITH EXAMPLE
Hi Sir?Mam, If i complete SAS CLINICAL in India, can i step forward to USA for job trials? How far is it possible? Am a B.pharm student ,willing to make up my Master's degree too,will this both M.Pharm and SAS help me out to get a job in USA? Please help me out with a good answer.
what is meant by artwork review and handling procedure with an example?
What is the basic requirement for preparing drug master file , like EDMF , USDMF ?
