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Mubychem Group, is a mature manufacturing company since generations. Engaged in manufacture and supply of Pharmaceutical Intermediates and Excipients, Oil field & fracturing chemicals, Specialty tailor made grades of chemicals in India. With several manufacturing facilities in India and world wide contacts and toll manufacturers we are exporting to all the countries in the world.. |
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Sodium Starch Glycolate BP USP NF Manufacturers
For MSDS Sheet Click MSDS of Sodium Starch Glycolate BP USP NF Manufacturers
Sodium Starch Glycolate BP (Type A)
DEFINITION
Sodium salt of a cross-linked partly
O-carboxymethylated
potato starch.
Content
2.8 per cent to 4.2 per cent of Na (A
22.99) (substance washed with ethanol (80 per cent V/V) and dried).
CHARACTERS
Appearance
White or almost white, fine, free-flowing
powder, very hygroscopic.
Solubility
Practically insoluble in methylene chloride. It gives a translucent suspension
in water.
Examined under a microscope it is seen to consist of: granules,
irregularly shaped, ovoid or pear-shaped, 30-100 µm in size, or rounded,
10-35 µm in size; compound granules consisting of 2-4 components occur
occasionally; the granules have an eccentric hilum
and clearly visible concentric striations; between crossed
nicol
prisms, the granules show a distinct black cross intersecting at
the hilum; small crystals are visible at the
surface of the granules. The granules show considerable swelling in
contact with water.
IDENTIFICATION
A. pH (see Tests).
B. Prepare with shaking and without heating a mixture of 4.0 g of the
substance to be examined and 20 ml of carbon dioxide-free water.
The mixture has the appearance of a gel. Add 100 ml of carbon
dioxide-free water and shake. A suspension forms that settles after
standing.
C. To an acidified solution, add iodinated potassium iodide solution.
The solution becomes blue or violet.
D. Solution S2 (see Tests) gives reaction of sodium.
TESTS
Solution S1
Centrifuge the suspension obtained in identification test B at 2500
g for 10 min. Collect carefully the supernatant liquid.
Solution S2
Place 2.5 g in a silica or platinum crucible and add 2 ml of a 500
g/l solution of sulphuric
acid. Heat on a water-bath, then cautiously over a naked flame,
raising the temperature progressively, then incinerate in a muffle
furnace at 600 ± 25 °C. Continue heating until all black particles have
disappeared. Allow to cool, add a few drops of dilute
sulphuric acid, heat and incinerate as
above. Allow to cool, add a few drops of ammonium carbonate solution,
evaporate to dryness and incinerate cautiously. Allow to cool and
dissolve the residue in 50 ml of water.
Appearance of solution S1
Solution S1 is clear and colourless.
pH
5.5 to 7.5. Disperse 1.0 g in 30 ml of
water.
Sodium glycolate
Maximum 2.0 per cent. Carry out the
test protected from light.
Sodium chloride
Maximum 7.0 per cent.
Iron
Maximum 20
ppm determined on 10 ml of
solution S2.
Heavy metals
Maximum 20
ppm.
1.0 g complies with test D. Prepare the reference solution using 2 ml of
lead standard solution (10
ppm Pb).
Loss on drying
Maximum 10.0 per cent, determined on 1.000 g by drying in an oven at
130 °C for 1.5 h.
Microbial contamination
It complies with the test for
Escherichia coli and Salmonella.
Sodium Starch Glycolate BP (Type B)
DEFINITION
Sodium salt of a cross-linked partly
O-carboxymethylated
potato starch.
Content
2.0 per cent to 3.4 per cent of Na (A
22.99) (substance washed with ethanol (80 per cent V/V) and
dried).
CHARACTERS
Appearance
White or almost white, fine, free-flowing
powder, very hygroscopic.
Solubility
Practically insoluble in
methylene chloride. It gives a translucent suspension
in water.
Examined under a microscope it is seen to consist of: granules,
irregularly shaped, ovoid or pear shaped,
30-100 µm in size, or rounded, 10-35 µm in size; compound granules
consisting of 2-4 components occur occasionally; the granules have an
eccentric hilum and clearly visible
concentric striations; between crossed nicol
prisms, the granules show a distinct black cross intersecting at the
hilum; small crystals are visible at the
surface of the granules. The granules show considerable swelling in
contact with water.
IDENTIFICATION
A. pH (see Tests).
B. Prepare with shaking and without heating a mixture of 4.0 g of the
substance to be examined and 20 ml of carbon dioxide-free water.
The mixture has the appearance of a gel. Add 100 ml of carbon
dioxide-free water and shake. A suspension forms that settles after
standing.
C. To an acidified solution, add iodinated potassium iodide solution.
The solution becomes blue or violet.
D. Solution S2 (see Tests) gives reaction of sodium.
TESTS
Solution S1
Centrifuge the suspension obtained in identification test B at 2500
g for 10 min. Collect carefully the supernatant liquid.
Solution S2
Place 2.5 g in a silica or platinum crucible and add 2 ml of a 500
g/l solution of sulphuric acid.
Heat on a water-bath, then cautiously over a naked flame, raising the
temperature progressively, and then incinerate in a muffle furnace at
600 ± 25 °C. Continue heating until all black particles have
disappeared. Allow to cool, add a few drops of dilute
sulphuric acid and heat and incinerate
as above. Allow to cool, add a few drops of ammonium carbonate
solution, evaporate to dryness and incinerate cautiously. Allow to
cool and dissolve the residue in 50 ml of water.
Appearance of
solution S1
Appearance of solution S1
Solution S1 is clear and
colourless.
pH
3.0 to 5.0. Disperse 1.0 g in 30 ml of
water.
Sodium glycolate
Maximum 2.0 per cent. Carry out the
test protected from light.
Sodium chloride
Maximum 7.0 per cent.
Iron
Maximum 20
ppm determined on 10 ml of
solution S2.
Heavy metals
Maximum 20 ppm.
Loss on drying
Maximum 10.0 per cent, determined on 1.000 g by drying in an oven at
130 °C for 1.5 h.
Microbial contamination
It complies with the test for Escherichia coli and
Salmonella.
Sodium Starch Glycolate BP (Type C)
DEFINITION
Sodium starch
glycolate (type C) is the
sodium salt of a cross-linked by physical dehydration, partly O-carboxymethylated
starch. It contains not less than 2.8 per cent and not more than 5.0 per
cent of Na (A 22.99),
calculated with reference to the substance washed with alcohol (80 per
cent V/V) and dried.
CHARACTERS
A white or almost white, fine, free-flowing
powder, very hygroscopic, soluble in water, practically insoluble in
methylene chloride. It gives a
translucent gel-like product in water.
Examined under a microscope it is seen to consist of granules,
irregularly shaped, ovoid or pear-shaped, 30 µm to 100 µm in size, or
rounded, 10 µm to 35 µm in size; compound granules consisting of two to
four components occur occasionally; the granules have an eccentric
hilum and clearly visible concentric
striations; between crossed nicol prisms, the granules show a distinct
black cross intersecting at the hilum; small
crystals are visible at the surface of the granules. The granules show
considerable swelling in contact with water.
IDENTIFICATION
A. It complies with the test for pH (see Tests).
B. Mix with shaking and without heating 4.0 g and 20 ml of carbon
dioxide-free water. The mixture has the appearance of a gel. Add 100
ml of carbon dioxide-free water and shake: the gel remains stable
(difference from types A and B). Keep the gel for the tests for
appearance of gel and pH.
C. To 5 ml of the gel obtained in
identification test B add 0.05 ml of iodine solution. A dark blue
colour is produced.
D. Solution S (see Tests) gives reaction of sodium.
TESTS
Solution S
Place 2.5 g in a silica or platinum crucible and add 2 ml of a 500
g/l solution of sulphuric acid.
Heat on a water-bath, then cautiously over a naked flame, raising the
temperature progressively, and then incinerate in a muffle furnace at
600 ± 25C. Continue heating until all black particles have
disappeared. Allow to cool, add a few drops of sulphuric acid
and heat and incinerate as described
above. Allow to cool, add a few drops of ammonium carbonate solution,
evaporate to dryness and incinerate cautiously. Allow to cool and
dissolve the residue in 50 ml of water.
Appearance of gel
The gel prepared under identification test B is
colourless.
pH
The pH of the gel prepared under identification test B is 5.5 to
7.5.
Sodium glycolate
Carry out the test protected from light.
(2.0 per cent).
Sodium chloride
Not more than 1 per cent.
Iron
10 ml of solution S complies with the limit test for iron (20
ppm).
Heavy metals
1.0 g complies with limit test D for heavy metals (20
ppm).
Loss on drying
Not more than 7.0 per cent, determined on 1.000 g by drying in an
oven at 100C to 105C for 4 h.
Microbial contamination
It complies with the test for Escherichia coli and
Salmonell).
Sodium Starch Glycolate USP NF
Sodium Starch Glycolate USP NF
Starch
carboxymethyl
ether, sodium salt.
Sodium Starch Glycolate is the sodium salt of a carboxymethyl ether of starch or of a cross-linked carboxymethyl ether of starch. It may contain not more than 7.0 percent of Sodium Chloride. The pH and assay requirements for Type A and Type B are set forth in the accompanying table.
|
pH |
% Sodium, combined as sodium starch glycolate |
|||
|
Type |
Min. |
Max. |
Min |
Max |
|
A |
5.5 |
7.5 |
2.8 |
4.2 |
|
B |
3.0 |
5.0 |
2.0 |
3.4 |
Identification—
A: Infrared Absorption
197K.
B: A slightly acidified solution of it is colored blue to
violet by the addition of iodine and potassium iodide TS 1.
C: To a 2-mL portion of the solution prepared for the test for
Limit of iron, add 4 mL of Potassium
pyroantimonate solution. If necessary,
rub the inside of the test tube with a glass rod. A white, crystalline
precipitate is formed.
Potassium pyroantimonate solution—To
2 g of potassium pyroantimonate add 100
mL of water. Boil the solution for about 5
minutes, cool quickly, and add 10 mL of a
solution of potassium hydroxide (3 in 20). Allow to stand for 24 hours,
and filter.
D: Sodium Starch Glycolate imparts an
intense yellow color to a non-luminous flame.
Microbial limits — It meets the
requirements of the tests for absence of Salmonella species and
Escherichia coli.
pH— Disperse 1 g in 30
mL of water. The pH of the resulting
suspension is either between 5.5 and 7.5 for Type A or between 3.0 and
5.0 for Type B.
Loss on drying— Dry it at 130 for 90 minutes: it loses not more
than 10.0% of its weight.
Heavy metals: 0.002%.
Limit of iron— (0.002%).
Limit of sodium chloride— To pass the test.
Limit of sodium
glycolate—
(2.0%).
Sodium Starch Glycolate BP USP NF Manufacturers:
MUBY CHEMICALS GROUP
DONGRI-CHINCHBUNDER, MUMBAI 400009, INDIA
TEL: (OFFICE)
91-22-23770100, 91-22-23726950, 91-22-23774610, 23723564.
e-mail: info@mubychem.com
