Shri G. S. Institute of Technology & Science, Indore (M.P.

)
Department of Pharmacy
Title: Quality specification for Croscarmellose Sodium

S.No. TEST SPECIFICATION

I.P.2007 B.P.2007 U.S.P.2007
1.0 Description White or greyish White or greyish --
white powder. white powder.
2.0 Solubility Insoluble in water. Insoluble in acetone,
anhydrous ethanol
and toluene.
--
3.0 Identification A) Shake 1g with A) Shake 1g with A) Shake 1g with
100ml of 0.00001% 100ml of 0.00001% 100ml of 0.00001%
w/v solution of w/v solution of w/v solution of
methylene blue and methylene blue and methylene blue and
allow to settle. The allow to settle. The allow to settle. The
substance under substance under substance under
examination absorbs examination absorbs examination absorbs
the methylene blue the methylene blue the methylene blue
and settles as a blue and settles as a blue and settles as a blue
fibrous mass. fibrous mass. fibrous mass.
B)Shake 1g with B)Shake 1g with B)Shake 1g with
50ml of water. 50ml of water. 50ml of water.
Transfer 1ml of the Transfer 1ml of the Transfer 1ml of the
mixture to a test- mixture to a test- mixture to a test-
tube, add 1ml of tube, add 1ml of tube, add 1ml of
water and 0.05ml of water and 0.05ml of water and 0.05ml of
a freshly prepared a freshly prepared a freshly prepared
4.0% w/v solution of 4.0% w/v solution of 4.0% w/v solution of
α-napthol in α-napthol in α-napthol in
methanol. Add 2ml methanol. Add 2ml methanol. Add 2ml
of sulphuric acid. A of sulphuric acid. A of sulphuric acid. A
reddish-violet color reddish-violet color reddish-violet color
develops at the develops at the develops at the
interface. interface. interface.
C)The solution C)The solution C) A portion of it
prepared from the prepared from the with water responds
sulphated ash in the sulphated ash in the to flame test for

S.No. TEST SPECIFICATION

Prepared by: Checked by: Approved by:
Name: Samridhi Mishra Name: Mr. Prakash Kumar Soni Name: Dr. T. R. Saini
Signature: Signature: Signature:
Date: Date: Date:
Pa
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 Shri G. S. Institute of Technology & Science, Indore (M.P.)
Department of Pharmacy
Title: Quality specification for Croscarmellose Sodium

I.P.2007 B.P.2007 U.S.P.2007

test for heavy metals test for heavy metals sodium.
gives reaction of gives reaction of
sodium salts. sodium salts.
4.0 pH 5.0 to 7.0 5.0 to 7.0 5.0 to 7.0
(determined using (determined using (determined using
1% w/v solution) 1% w/v solution) 1% w/v solution)
5.0 Heavy metal -- NMT 10ppm --
6.0 Sulphated ash 14.0 to 28.0% 14.0 to 28.0%
(determined on 2g (determined on 1g
--
using equal volume using equal volume
of sulfuric acid and of sulfuric acid and
water) water)
7.0 Water soluble NMT 10ppm NMT 10ppm
sustances
--
8.0 Sodium chloride NMT 0.5% NMT 0.5% for sum NMT 0.5% for sum
and Sodium of percent content of of percent content of
glycollate sodium chloride and sodium chloride and
sodium glycollate sodium glycollate
9.0 Degree of Between 0.60 and Between 0.60 and Between 0.60 and
substitution 0.85 0.85 0.85
10.0 Residue on -- -- 14 to 28%
ignition
11.0 Loss on drying NMT 10% NMT 10% NMT 10%
(determined by (determined by (determined by
drying 1g in an oven drying 1g in an oven drying 1g in an oven
at 105°C for 6hrs. at 105°C for 6hrs at 105°C for 6hrs

12.0 Settling -- 10 to 30ml 10 to 30ml

13.0 Microbial Total viable aerobic Total viable count:

contamination -- count: NMT 1000 NMT 1000 cfu per g.

S.No. TEST SPECIFICATION

I.P.2007 B.P.2007 U.S.P.2007
Prepared by: Checked by: Approved by:
Name: Samridhi Mishra Name: Mr. Prakash Kumar Soni Name: Dr. T. R. Saini
Signature: Signature: Signature:
Date: Date: Date:
Pa
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 Shri G. S. Institute of Technology & Science, Indore (M.P.)
Department of Pharmacy
Title: Quality specification for Croscarmellose Sodium

Bacteria and 100 Molds and yeast

Fungi per g count: NMT 100 cfu
determined by plate per g.
count method.
E.coli: absent E.coli: absent
14.0 Storage -- -- Well closed
container.

Note: NMT refers to “Not More Than”

Storage: In a well closed container.

Approved expiration date:
Approved supplier:
References: I.P.2007, B.P.2007, U.S.P.2007

Prepared by: Checked by: Approved by:

Name: Samridhi Mishra Name: Mr. Prakash Kumar Soni Name: Dr. T. R. Saini
Signature: Signature: Signature:
Date: Date: Date:
Pa
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