How we can identify process related and degradation impurity in single method with short period?

340

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inhouse product is in capsule form in combination and RLD is in tablet form then can we proceed for multimedia CDP? in inhouse capsule product disso is paddle with sinker in release media is there then RLD product in tablet form then with same as paddle with sinker we can proceed n.a.?

297

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

311

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How to set specification of assay, fisdolution and related substances?

372

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how to qualify the impurity?

328

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what is the acceptance criteria for enteric coated tablets in 0.1n hcl validation in each parameter?

351

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What is the formula for relative diffrence for standard solution in solution stability in validation?

314

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How require to perform linearity as per ANVISA? What are the acceptance criteria?

729

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[3/30, 13:29] Manoj P Venkatpurwar: How hplc column selection according to structure? How mobile phase buffer selection on molecule structure?

318

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in api coa analytical method given as Ph Europe which api used in formulation in this api coa method given Ph Europe so for Analytical methic for finished product we require to refer Ph Europe monograph ok n.a.? So any extra impurities which is given in USP monograph of api or finished product need not require to monitor on above case n.a.? but how require to do specificity?

217

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in DMF having extra impurities and in api COA also having extra imp than USP or BP product then how require to proceed?

350

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we can use expired sample for validation and analyst qualification?

308

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If vendor having more imp than monograph then how to proceed? and how to set spec?

346

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If change in specification which parameter require to do for validation? if change in chromtographic condition then which parameter? if api change then which parameter? if change composition then which parameter? if old method not work out then whicj parameter? if additional one impurity added then which parameter of validation require to do on above each conditions? elaborate separately

363

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how require to set assay concentration for standard and sample?

377

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