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' #*ritas
Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
Version No.:01 Superseded doc. No,: VRME/C/06'l 2/002 Review Date : 23 Jan2017
CONTENT
1. Description
2. Solubility
3. ldentification
4. Assay (ignited basis)
5 Loss on ignition,
6. Arsenic
7. pH
8. Loss on drying
9. Revision History
DISTRIBUTION LIST
QC Laboratory 01
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VERITAS PHARMACEUTIGALS LIMITED,
Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
ffieritas
STANDARD TEST PROCEDURE
Take about 1 gm of sample in a watch glass and observe for its physical appearance, color, etc. using a white background.
Limit: Light white non gritty powder of exkemely fine particle size (about 15 pm).
Solubility
Procedure:
Descriptive term Approximate volume of Solvent in millilitres per gram of solute
Very soluble Less than 1
Soluble From 10 to 30
Limit: lnsoluble in water and in acid (except hydrofluoric acid); soluble in hot solution of alkali hydroxides.
ldentification
A: Transfer about 5 mg to a platinum crucible, and mix with about 200 mg of anhydrous potassium carbonate. lgnite at a
red
heat over a burner for about 10 minutes, and cool. Dissolve the melt in 2 mL of freshly distilled water, warming if necessary,
and slowly add 2 mL of ammonium molybdate TS to the solution: a deep yellow color is produced"
B: place 1 drop of the yellow silicomolybdate solution obtained in ldentification test A on a filter paper, and evaporate the
blue,
solvent. Add 1 drop of aiaturated solution of o{olidine in glacialacetic acid to reduce the silicomolybdate to molybdenum
and place the paper over ammonium hydroxide: a greenish blue spot is produced.
4. Assay
Transfer about 500 mg of Colloidal Silicon Dioxide to a tared platinum crucible, ignite at 1000 r25 'for 2 hours, cool in a
desiccator, and weigh.ldd 3 drops of sulfuric acid, and add enough alcoholto just moisten the sample completely. Add 15 mL
of hydrofluoric acid, and in a weil-ventilated hood evaporate on a hot plate to dryness, using medium heat (95 to 105 ) and
taking care that the sample does not spatter as dryness is approached. Heat the crucible to a red color with the aid of a Bunsen
burnir. lgnite the residue at 1000 t25
for 30 minutes, cool in a desiccator, and weigh. lf a residue remains, repeat the
procedure, beginning with "add 15 mL of hydrofluoric acid." The weight lost by the assay specimen, previously ignited at 1000
I 25 , represents the weight of Si02 in the portion taken..
IF THE DOCUMENT IS SIGNED BY BLUE IN& IT IS A MASTER DOCUMENT AND CAN NOT BE USED FOR ROUTINE WORK
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VERITAS PHARMACEUTICALS LIMITED,
ffieritas Muradpur, Vannara, Mouchak, Gazipur, Bangladesh
6. Arsenic (211)
Prepare the Test Preparation as follows. Transfer 2.5 g to a flask, add 50 mL of 3 N hydrochloric acid, and reflux for 30 minutes
using a water condenser. Cool, filter with the aid of suction, and hansfer the filtrate to a 100-mL volumetric flask. Wash the filter
and flask with several portions of hot water, and add the washings to the flask. Cool, dilute with water to volume, and mix: a
15.0-mL portion of this solution, to which 3 mL of hydrochloric acid has been added, meets the requirements of the test, the
addition of the 7 N sulfuric acid being omitted. The limit is 8 pg per g.
7. pH (zst)
Disperse 1 g in 25 mlwater
Limit:3.5 - 5.5
Dry a crucible in an oven at 1050C for 30 minutes. Place it in desiccators, allow cooling and weighing. Accurately weigh about
1.0 g of sample in the crucible and dry in an oven at 100-105oC.Remove the crucible from oven and allow cooling in
desiccators and reweigh. Calculate the percentage of loss on drying using the following formula:
Calculation:
(W1-W2)x100
(w1_c)
W1 = Weight of the weighing bottte and sampte before drying (in g).
W2 = Weight of the weighing botile and the sample after drying (in g).
9. Revision History
TP/1 103001/01 01 Jan2014 To detail the procedure for analysis of Colloidal Silicon
IF THE DOCUMENT IS SIGNED BY BLUE INIC IT IS A MASTER DOCUMENT AND CAN NOT
BE USED FOR ROUTINE WORK
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