Answer / amar

For USP official method, Partial validation required
like Precision, Linearity, Accuracy, Specificity
Because of in our product we will check whether the recovery,
Method Repetability parameters are coming.

Answer / nikhil gandhi

Method is already Pharmacopial so only need some
varification parameter like Specificty & Precision & Force
Degradation is required for Assay & Related Compound only.
(due to excipient.)

Answer / akshay

Partial validation need to do. Different path of synthesis can be use by diff. Manufacturar so need to study impurity profiling, solvents etc.

Answer / gokul yeole (archpharmalabs)

Yes,For USP official method it mens compandial methods
should be validate, Partial validation required
like Robtness,rugdness,Precision, Linearity, Accuracy,
Specificity
Because of in our product we don`t know which system and
lab will use for analysis.
non compandial methods do all parameter which is mentioned
in ICH Q2 guidline.

Answer / mayank sanghvi

Purity Tests: to ensure that all the analytical procedures performed allow an accurate statement of the content of impurities of an analyte, i.e.
related substances test, heavy metals, residual solvents content, etc.

Assay (content or potency):
to provide an exact result which allows an accurate statement on the
content or potency of the analyte in a sample.

Answer / venugopal reddy

Based on the USP 1225 generachapter,

Analytical methods described in USP–NF are not required to validate the accuracy and reliability of these methods, but merely verify their suitability under actual conditions of use. Recognizing the legal status of USP and NF standards, it is essential, therefore, that proposals for adoption of new or revised compendial analytical procedures be supported by sufficient laboratory data to document their validity.

For LOD and LOQ determination which method is accurate? (slopemethod or s/n ratio method)

4 Answers   Reddy Labs,

hii, i'm had a sample of 1L that gone through extraction & evaporation. i used 0.5ml of methanol for reconstitution before injecting the sample to HPLC. i made a calibration curve using a standard solution but now i'm confused about how to display the concentration i got from the sample. for ex. i got 0.2ug/ml how i'm gonna explane this is for the 1L ? please help .. i'll really appreciate it thanks

1 Answers  

Can anybody tell me how to measure Redox potential in an aerobic matrix, for e.g., soil etc.?

2 Answers  

why we are using hexane in calibration of number of drop per mL

0 Answers  

when we have polar type of sample and solvnt hen which type of stationry phase we have to use

3 Answers  

what is reverse phase chromarography&normal phase chromatography

4 Answers   Aurobindo,

Difference Between End Cap HPLC Column and Non End Cap Column

2 Answers  

why we get negative values in uv when i placed sample which has some concetration but not in standard

1 Answers   Nirma,

how we do assay of urea, ammonium sulpate, ammonium nitro pospate etc

1 Answers   Alembic,

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

0 Answers  

Ratio of Water and Acetonitrile(diluent) is not recommended to use in cleaning method validation,why?

0 Answers   Aurobindo, Reddy Labs,

what is dissolution

6 Answers   DRL,