Answer Posted / b.suresh naidu

OOS-Out of Specification. It means any result obtained out
side the pre defined specefied limit.

OOT-Out of Trend. It means any stability result that is not
within the expected trend, either in comparison with other
stability batches or with respect to previous/Initial
station results obtained during a stability study (Eg. This
may be of batch to batch, pack to pack,etc).Moreover this
is a alert message that may trigger to OOS.

Need: Since the products are human consumable, it may have
impact on the safety of the patient.
By monitoring these, there can be control on the
prodcuts process and can have continous improvement.

If suppose 10 methods of dissolution given in pharmacopoeial for single content product then which method out of 10? or all 10 require to follow?

1046

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How to fix the sample conc. in Related substances test by HPLC?

1145

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what is difference in ods I ods II is this is realy from sorbent / packing characteristics or from other means

2011

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why require to do water content for drug product?

886

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In IR spectra, generally a molecule vibrates without apply emr or ir light?

2031

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how you start RS method development when for new product?

780

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on the basis of bcs class how to proceed the solubility?

834

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How they found 1mL of K.F reagent is equivalent to 5mg of water and if we change the composition of K.F reagent, is it can neutralize more amount of water?

1835

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what is classification of elemental impurities? what is risk assement in elemental impurities?

811

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what is mean by dissolution biowaiver study?

999

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What is a difference between potency and purity?

1262

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Is it nessesary all multimedia dissolution require descriminatory?

863

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what is the origin to prepare standard operating procedure

2407

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How to start the dissolution development for unknown tab?

1740

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in dissolution why pool sample needed? in which type of drug pool sample need?

3225

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