General Test Procedure Identification by Solubility

1. Purpose
   1. This procedure is applicable to all incoming Raw materials, In-process and Finished products.
2. Apparatus
   1. Calibrated Balance.
3. Reagents
   1. Solvent as mentioned in STP
4. Procedure
   1. Weigh accurately a suitable quantity of sample into a glass stoppered test tube and add specified

                           quantity of solvent as per the table given below.

1. 2. Shake vigorously to dissolve, keep aside for 15 minutes.
   3. If sample has not been completely dissolved repeat step no. 2.
   4. The term miscible is used to describe a liquid that is miscible in 1:1 proportion with a stated solvent:
      

      Sr. No	Solubility term	Volume of solvent (in part)	Weight of sample & Quantity of solvent
      	Very soluble	Less than 1	5g in 5ml
      	Freely soluble	1 to 10	1g in 10ml
      	Soluble	10 to 30	0.5g in 15ml
      	Sparingly soluble	30 to 100	0.1g in 10ml
      	Slightly soluble	100 to 1000	0.05g in 50ml
      	Very slightly soluble	1000 to 10,000	0.01g in 100ml
      	Practically insoluble	More than 10,000	NA

      Soluble articles, when brought into solution, may show traces of physical impurities, such as minute

                               fragments of filter paper, fibers and other particulate matter, unless limited or excluded by definite

                                  tests or other specifications in the individual monograph.

5. Reference
   1. IP
6. Revision History

Revision No.	Details of Changes	Reason for change
00	New GTP	NA

End of Document

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