The document contains details about a student named Srikanth Bandi enrolled in the Pharmaceutics department. It discusses accelerated stability testing, which involves exposing pharmaceutical products to elevated temperatures to simulate long-term shelf conditions over a shorter time period. The objectives and guidelines from the ICH are outlined, including storage conditions, sampling times, and test parameters. The document also describes the equipment used and process for conducting accelerated stability studies.

1. NAME : SRIKANTH BANDI
H.T.NO : 11H61S0303
DEPARTMENT : PHARMACEUTICS
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2. C0NTENTS:
Definition
Why….?
Objectives
ICH guidelines
How to Perform?
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3.  A method by which a product is exposed
to elevated temperature simulating what
would happen over longer periods on the
shelf life.
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4.  The stability of pharmaceutical
preparations should be evaluated by
exposing the product to normal shelf
conditions for a year or extended
periods. The rate of decomposition is
slow at room temperature .Such a
method is time consuming and
uneconomical.
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5.  To predict the shelf life of a
pharmaceutical product by accelerating
the rate of decomposition ,preferably by
increasing the temperature.
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6.  Describes regarding sampling times ,storage conditions&
specific test parameters for each dosage form.
The FDA & The expert working group of the ICH of technical
requirements for the registration of pharmaceuticals for human
use have published guidelines for conducting the actual studies.
 The ICH guidelines includes 4 batches:
Batch-Q(Quality)
Batch-S(Safety)
Batch-E(Efficacy)
Batch-M(Multidisciplinary)
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7.  Q 1A(R2) :Stability testing of new drug substances &
products.
Q 1B :Photo stability testing of new drug substances &
products.
 Q 1C :Stability testing for new dosage forms.
 Q 1D :Bracketing & Matrixing designs for stability
testing of new drug substances & products.
 Q 1E :Evaluation for stability data.
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8.  These guidelines provide definitions of key terms & principles used in
the stability testing of drug substances& drug products.
 ICH outlined a combination of temperature & humidities for stability
studies for most of the drug products. These include…..
-15 C ±5 C
5 C ±3 C /Ambient humidity
25 C±2 C /60%RH±5%,
30 C±2 C/60% RH±5%,
40 C±2 C/75%RH±5%.
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9.  For liquid products , stored in semi permeable containers ,
subject to water loss , exposure to lower humidities like…..
25 C ±2 C/40% RH±5%,
30 C ±2 C/40% RH±5%,
40 C ±2 C/15% RH±5% is needed.
 Also a high intensity light cabinet& a cycling chamber
capable of cycling both temperature and humidity are needed.
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10. STABILITY CABINETS:
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11. STABILITY CABINETS:
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12.  Drug liquid preparations are stored at elevated temperatures
viz.,50C, 60 C, 70 C, 80 C, 100 C, 121 C.
 In addition ,the samples should be studied at 40 C,75%RH &
incubator temperature.
 To confirm the results obtained from Accelerated stability
studies, it is necessary to simultaneously conduct experiments at
room temperature i.e., 30 C,70% RH & or refrigerator temperature
i.e.,4-5 C.
 During different time intervals , samples are withdrawn.
 The sampling may be done at:
3 month intervals during the 1st year,
6 month intervals during the 2nd year&
14 June 2012 yearly there after.
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13.  The drug content is estimated
using a stability indicating
assay method.
 In this…..
1. Draw a plot by taking any
conc. like C or log C against
Time.
2. Graph is drawn for different
elevated temperatures.
3. Lenear relationships are
obtained & These have
different slope.
4. K value for each
temperature are
calculated.
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14. 5. Log k values are then
plotted against reciprocal
of absolute temperature.
6. Extrapolate the straight
line to room
temperature(25-30 C)& read
the log k/k25 value on Y
axis.
7. Substitute the k25 value in
the equation of
appropriate order to get
shelf life of the product
under normal shelf
conditions.
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15. BOOKS:
1) Gilbert S. Banker , Christopher T. Rhodes , Modern Pharmaceutics,
4th Edition, Revised& Expanded.
2) C. V. S. Subrahmanyam , J. Thimma setty , Sarasija Suresh & V. Kusum
Devi, Pharmaceutical engineering principles& Practices, New
Delhi,2010.
INTERNET:
1) www.ich.org
2) www.gmp-compliance.org
3) www.pharma.gally.ch
4) www.who.int
5) www.sensitech.com
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