Colloidal Silicon Dioxide
SiO2 60.08
Silica
[7631-86-9].
SiO2 60.08
Silica
[7631-86-9].DEFINITION
Colloidal Silicon Dioxide is a submicroscopic fumed silica prepared by the vapor-phase hydrolysis of a silicon compound. When ignited at 1000
for 2 h, it contains NLT 99.0% and NMT 100.5% of SiO2.
for 2 h, it contains NLT 99.0% and NMT 100.5% of SiO2.IDENTIFICATION
• A. Procedure
Analysis:
Transfer 5 mg to a platinum crucible, and mix with 200 mg of anhydrous potassium carbonate. Ignite at a red heat over a burner for 10 min, 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.
Acceptance criteria:
A deep yellow color is produced.
• B. Procedure
[Note—Avoid contact with o-tolidine when performing this test, and conduct the test in a well-ventilated hood. ]
Analysis:
Place 1 drop of the yellow silicomolybdate solution from Identification test A on a filter paper, and evaporate the solvent. Add 1 drop of a saturated solution of o-tolidine in glacial acetic acid to reduce the silicomolybdate to molybdenum blue, and place the paper over ammonium hydroxide.
Acceptance criteria:
A greenish blue spot is produced.
ASSAY
• Procedure
Sample:
500 mg
Analysis:
Ignite the Sample in a tared platinum crucible at 1000 ± 25 for 2 h, cool in a desiccator, and weigh. Add 3 drops of sulfuric acid, and add enough alcohol to just moisten the sample completely. Add 15 mL of hydrofluoric acid, and in a well-ventilated hood evaporate on a hot plate to dryness, using medium heat (95–105) 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 burner. Ignite the residue at 1000 ± 25 for 30 min, cool in a desiccator, and weigh. If a residue remains, repeat the Analysis, beginning with “Add 15 mL of hydrofluoric acid”. The weight lost by the assay specimen, previously ignited at 1000 ± 25, represents the weight of SiO2 in the portion taken.
for 2 h, cool in a desiccator, and weigh. Add 3 drops of sulfuric acid, and add enough alcohol to just moisten the sample completely. Add 15 mL of hydrofluoric acid, and in a well-ventilated hood evaporate on a hot plate to dryness, using medium heat (95–105) 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 burner. Ignite the residue at 1000 ± 25 for 30 min, cool in a desiccator, and weigh. If a residue remains, repeat the Analysis, beginning with “Add 15 mL of hydrofluoric acid”. The weight lost by the assay specimen, previously ignited at 1000 ± 25, represents the weight of SiO2 in the portion taken.
Acceptance criteria:
99.0%–100.5% on the previously ignited basis
IMPURITIES
Inorganic Impurities
• Loss on Ignition 
733
:
Ignite the portion of Colloidal Silicon Dioxide, retained from the test for Loss on Drying, at 1000 ± 25 to constant weight: the previously dried Colloidal Silicon Dioxide loses NMT 2.0% of its weight.
733:
Ignite the portion of Colloidal Silicon Dioxide, retained from the test for Loss on Drying, at 1000 ± 25 to constant weight: the previously dried Colloidal Silicon Dioxide loses NMT 2.0% of its weight.
• Arsenic, Method 1 211
211
Sample solution:
To 2.5 g add 50 mL of 3 N hydrochloric acid, and reflux for 30 min using a water condenser. Cool, filter with the aid of suction, and transfer 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, and dilute with water to volume.
Analysis:
A 15.0-mL portion of Sample 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.
Acceptance criteria:
NMT 8 ppm
SPECIFIC TESTS
• pH 791:
3.5–5.5, in a (1 in 25) dispersion
791:
3.5–5.5, in a (1 in 25) dispersion
• Loss on Drying 731:
Dry in a tared platinum crucible at 105 for 2 h: it loses NMT 2.5% of its weight. Retain the dried specimen in the crucible for the test for Loss on Ignition.
731:
Dry in a tared platinum crucible at 105 for 2 h: it loses NMT 2.5% of its weight. Retain the dried specimen in the crucible for the test for Loss on Ignition.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Robert H. Lafaver, M.S.
Scientific Liaison 1-301-816-8335 |
(EXC2010) Monographs - Excipients |
USP35–NF30 Page 1949
Pharmacopeial Forum: Volume No. 31(4) Page 1232