Golgappa.net | Golgappa.org | BagIndia.net | BodyIndia.Com | CabIndia.net | CarsBikes.net | CarsBikes.org | CashIndia.net | ConsumerIndia.net | CookingIndia.net | DataIndia.net | DealIndia.net | EmailIndia.net | FirstTablet.com | FirstTourist.com | ForsaleIndia.net | IndiaBody.Com | IndiaCab.net | IndiaCash.net | IndiaModel.net | KidForum.net | OfficeIndia.net | PaysIndia.com | RestaurantIndia.net | RestaurantsIndia.net | SaleForum.net | SellForum.net | SoldIndia.com | StarIndia.net | TomatoCab.com | TomatoCabs.com | TownIndia.com
Interested to Buy Any Domain ? << Click Here >> for more details...

Any molecule is filing for ANDA purpose, what are the
dissolution requirements / specifications needed ?

Answer Posted / bharadwaja

anda filing is done for generic drugs , for the requirements
of dissolution first refer to innovators dissolution studies
and later check the pharmacopeia of particular country in
which it is to be marketed and check the site of ogd to get
the details of the medium and apparatus to be used ...

Is This Answer Correct ?    9 Yes 0 No



Post New Answer       View All Answers


Please Help Members By Posting Answers For Below Questions

If inhouse hplc related substance method is completly diffrent from Usp for finished proďuct with diffrent impurities then how require to prove method equivalecy?

817


4. Describe the operation of the Craig apparatus. Chapter.3 Equilibrium Processes in Separations

2768


What is a difference between potency and purity?

1261


What are modes of quantification in related substances

2212


How we choose the mobile phase for method development.?

1270


in gas chromatography what is the difference between gas flow rate and average linear velocity ?

2652


What is the formula to determine the concentration of M of a solution given the % transmittance? Use %T = 43.7 as an example.

2756


Why Ethanol is Used for Standardization of GC Head space?

4269


in which situation ion pair agent require to use?

799


what is turbidimetric titration?Give 2 examples.

2733


how the compound separate in coulunm,explain

2593


Please give idea about method development for cleaning method and how maco level establish

793


WHAT IS THE PARAMETER FOR THE SELECTION OF MOBILE PHASE IN HPLC?

1250


why require to add enzymes in capsules dissolution only? is it require to tablet also?

725


From where require to take the RLD sample?

804