Interested to Buy Any Domain ? << Click Here >> for more details...
What are the significance of MKT in stability study.
- 1 Answers
- 7464 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
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.
from hplc chromatogram how can we say that calibration is needed now?
difference between RF and correction factor?
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 do IR test of hydroscopic materials
What are the regulatory commitments in markets like USA, Canada, Europe, Brazil, South Africa and Japan
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...
what is the leak test procedure of filled bottles (liquid)
when i come in contact with any metal items or clothes of fur i find myself shock and when run my fingers on fur clothes or matters, i find sparks. Is there any vitiams deffecieny in my body. If so, what i have to do?
how to calculate potency of working standard by using mass balence method & this calculated potency is on as basis or on anhydrous/ dried basis
while formulation of Gliclazide floating tablets why we are using direct cmpression technique why not wet granulation and what happend with that
What interests you about the position of Medical Librarian in our company?
How can I assign a retest date for solvents e.g. toluene, methanol, etc?
Explain difference between sonication and homozinization?
when we connect the capacitor banks in series with the circuit? 2 144 pH is having unit?
