Pharmaceuticals and Biopharmaceuticals - Test Request

Project Description

FDA cGMP pharmaceutical Laboratory needed for viscosity testing: Magnesium Aluminium silicate. Sample solution: After determining the Loss on Drying, weigh a quantity of Magnesium Aluminum Silicate, equivalent to 25.0 g on the dried basis. Over a period of a few seconds, transfer the undried test specimen to a suitable 1-L blender jar containing an amount of water, maintained at a temperature of 25 ± 2°, that is sufficient to produce a mixture weighing 500 g. Blend for 3 min, accurately timed, at 14,000?15,000 rpm (high speed).
[Note?Heat generated during blending causes a temperature rise to above 30°.]
Analysis: Transfer the contents of the blender to a 600-mL beaker, allow to stand for 5 min, and adjust, if necessary, to a temperature of 33 ± 3°. Using a suitable rotational viscometer equipped with a spindle as specified below, operate the viscometer at 60 rpm for 6 min, accurately timed, and record the scale reading.
For Type IA, use a spindle having a cylinder 1.87 cm in diameter and 0.69 cm high attached to a shaft 0.32 cm in diameter, the distance from the top of the cylinder to the lower tip of the shaft being 2.54 cm, and the immersion depth being 5.00 cm (No. 2 spindle). If the scale reading is greater than 90% of full scale, repeat the measurement, using a spindle similar to the No. 2 spindle but having the cylinder 1.27 cm in diameter and 0.16 cm high instead (No. 3 spindle).
For Type IC, use a No. 3 spindle. If the scale reading is greater than 90% of full scale, repeat the measurement using a spindle consisting of a cylindrical shaft 0.32 cm in diameter and having an immersion depth of 4.05 cm (No. 4 spindle).
For Types IB and IIA, use a No. 2 spindle.
Acceptance criteria
Type IA: 225?600
Type IB: 150?450
Type IC: 800?2200
Type IIA: 100?300

Project Information

Number:16-02158

Industry:Pharmaceuticals and Biopharmaceuticals

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