RLD (reference listed drug) characterization is an important part for generic product development. If the characterization is performed accurately, it's more easy to compare between RLD and Test product. So as a preformulation study RLD characterization should give high importance. Here we try to enlisted the parameters to be checked for RLD/RS (Solid product) characterization.


A list of Parameters to be Checked During RLD/RS Characterization

  • BRAND NAME
  • GENERIC NAME
  • DOSAGE FORM
  • PACKAGING DESCRIPTION
  • STRENGTH
  • COATED/ UNCOATED
  • MANUFACTURER
  • DISTRIBUTOR
  • SIZE &SHAPE
  • APPEARANCE
  • COLOR
  • WEIGHT OF TABLET
  • WEIGHT OF TABLET (without coating layer)
  • THICKNESS
  • DISINTEGRATION TIME 
  • APPEARANCE OF TABLET (after disintegration at acid stage)
  • DISINTEGRATION BEHAVIOUR 
  • DISINTEGRATION TIME (without coating layer)
  • pH of Tablet (01 tablet in 20 ml PW)
  • LOD of Tablet
  • BATCH NUMBER & EXP. DATE
  • NDC No.
  • EXCIPIENTS 
  • EXISTING TABLET  TOOLING

A Typical F2 and F1 Calculation





Selection of size & shape of tablet & capsule for generic manufacturer are as follows-

1. For RLD tablet size <=17 mm,
a)No more than 20% larger then RLD
b) No more then 40% larger the volume of RLD.

2. For tablet size 17 mm or larger
a) Size should not larger then RLD.
b) Volume should not larger then RLD.

3. Tablet size should not exceed 22 mm and Capsule size should not exceed #00.

4. For capsule size #3 or less, one size larger then RLD can be manufactured but for capsule size #2 or larger one size larger can be manufactured with justification but not more then #00.



Related Articles

Tags in:  difference between reference listed drug and reference standard, referencing approved drug products in anda submissions, rld pharmaceutical, reference listed drug fda, reference listed drug orange book, reference listed drugs.