Question { Natco, 25843 }

What is discriminating media? How can u justify/select that
which media (pH etc...)is suitable for your dissolution study
of your compound?

Answer

A releasing medium is the one that promotes
solubilization of the drug substance from a pharmaceutical
dosage form without further qualification.

When selecting the dissolution medium, physical and
chemical data for the drug substance and drug product need
to be considered,selecting the composition of the medium,
the influence of buffers, molarity, pH, and surfactants
on the solubility and stability of the drug also need to be
evaluated,
The most common dissolution medium is dilute
hydrochloric acid, however other media commonly used
includes buffers in the physiologic pH range of 1.2 to 7.5,
simulated gastric or intestinal fluid (with or without
enzymes), water, and surfactants (with or without acids or
buffers)such as polysorbate 80, sodium lauryl sulfate, and
bile salts. The use of aqueous-organic solvent mixtures,
while generally discouraged, can also be used if justified.
Enzymes are also sometimes used in the media when testing
gelatin capsule products.
Media volumes are typically in the range of 500-1000
mL, with 900 mL the most common volume. Volumes as high as
2-4 L have been used, and as low as 100 mL for high potency
(low dosage strength) drug formulations.

Question { MSN Pharma, 13453 }

How we can determine OOT limit in Stability

Answer

An OOT result shall be identified by comparing the result
to a predetermined acceptable range. Any result outside
this range shall be considered as an OOT.

To identify the OOT result, there are two methods.
1. Extensive Review Range
2. ±3 Sigma Method

If number of batches are less than 50, extensive review
range method shall be followed
If number of batches are more than 50, +/- sigma method
should be followed
After completion of 50 batches/5 intervals, average and
standard deviation of the respective parameter
shall be calculated. Further ±3 sigma values shall be
defined as below

+3 sigma = Average + (3 x Standard deviation)
-3 sigma = Average - (3 x Standard deviation)

Ex: Assay : 98.00% to 101.00%
Average of 50 batches : 99.81%
Standard deviation : 0.20
+3 sigma = 99.81 + (3 x 0.20) = 100.41%
-3 sigma = 99.81 – (3 x 0.20) = 99.21%
OOT range : ‘98.00 to 99.20%’ and ‘100.42%
to 101.00%

Question { Reddy Labs, 10495 }

Which charcoal is used to decolourise the raw sugar?

Answer

Bone-Black or Animal Charcoal;