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General Test Procedure (GTP) for Solubility

PURPOSE
To lay down the procedure for solubility of the materials

APPARATUS
Analytical balance
Stoppered test tubes - 10 ml, 20 ml & 50 ml
Conical flasks – 100 ml & 250 ml
Graduate pipettes / Bulb pipettes

REAGENTS
Freshly distilled water
Organic solvents such as methanol, ethanol, methylene chloride etc. - AR grade

PROCEDURE
  • Transfer an accurately weighed sample into a glass-stoppered test tube and add a specified quantity of solvent as per the table given below.
  • Shake vigorously for one minute, and keep aside for 15 minutes.
  • In case, if the sample is not completely dissolved, repeat step 2.
  • The term miscible is used for liquid samples and describes a sample that is miscible in all proportions with the stated solvent.

Descriptive term

Approximate volume of solvent in milliliters per gram of solute

Very soluble

Freely soluble

Soluble

Sparingly soluble

Slightly soluble

Very slightly soluble

Practically insoluble

Less than 1

From         1              to           10

From         10            to           30

From         30            to           100

From         100          to           1000

From        1000         to           10000

More than                               10000


REFERENCES
USP, BP and Pharmeuropa Technical Guide issued in December 1999.

Notes
  1. To check the solubility for very soluble, free soluble, soluble, and sparingly soluble use 100mg to 1000mg of sample.
  2. To check the solubility for slightly, very slightly, and practically insoluble use 10 mg to 100 mg of sample.

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