Answer Posted / d.sambireddy

oos-out of specifications and oot-out of trend
this two words regular using all pharma industry

1) When ever we are using OOT controling of our quality
and controling of our process

2)Where ever we are using OOS(suppose in investigation
product is not meets the specification)

we will improve next future quality and avioding mistakes
from analysis and processing

2. Two grams of Benzoic acid are dissolved in 200 ml of water and extracted with 200 ml of diethyl ether. The distribution coefficient of benzoic acid is 100, and its dissociation constant is 6.5 10-5. Calculate the distribution ratio (D) of benzoic acid at pH 2, 5, and 6. 3. Calculate D at pH 2 to 10 (1 unit apart) in the above problem, and plot D versus pH.

2170

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While performing TOC sst analysis Zero shift disabled & sample analysis zero shift enabled why?

2786

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in api coa contains only process impurities and in product coa contains degradation impurities?

651

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analytical method validation require to with respect to release specification or shelf life specification?

731

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What is the difference between chromatographic purity and related substances?

1295

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Difference between hlaf and rlaf

2048

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what is the extinction coefficient for Indomethacin or at 319nm wave length.

3989

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What is diffrence between extractable volume and deliverable volume? Answer pls

4488

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we can use expired sample for validation and analyst qualification?

746

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WHY given much noise PDA dector then VWD Dector

2040

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Why dissolution test is not performed in all of the products

2480

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why we use a particular hplc column for a particular compound give reasons?please

2682

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Why we use potassium dichromate in uv calibration Exact reason behind it??

1183

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Ph meter can show more than 14 ph reading? Why ph range in between 1 to 14 only?

685

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What is the difference between Discriminating media and DPDM(Dissolution Profile with Different Media)

7471

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