| Particulars |
US-NF |
BP / EP |
| Description |
Hard, brittle, free flowing Spherical
masses. |
Hard, brittle, free flowing Spherical
masses. |
| Identification |
A water slurry
of the insoluble portion of the sample is coloured
reddish violet to deep blue by iodine TS |
A) By TLC
B) By Chemical Reaction.
C) By Chemical Reaction. |
| Specific optical rotation.
(On dried basis) |
NLT +41° & NMT +61° |
---------- |
Microbial limits Total
Aerobic Microbial count.
Fungi
Staphylococcus aureus and pseudomonas aeruginosa.
Salmonella species & Escherichia coli |
NMT 100 cfu per g.
----------
Absent in 1 g
Absent in 1 g |
NMT 1000 cfu per g.
NMT 100 cfu per g.
----------
Absent in 10 g |
| Loss on drying |
NMT 4.0 % |
NMT 5.0 % |
| Residue on ignition.
|
NMT 0.25 % |
---------- |
| Fineness / particle
size |
NLT 90 % of
its passes the coarser sieve size stated in the
labeling. NMT 10 % passes the finer sieve size
stated in the labeling |
Minimum of 90
% of the sugar spheres are between the lower and
the upper limits of the size of the sugar spheres
stated on the label |
| Heavy metals |
NMT 5 µg per g. |
NMT 5 ppm |
| Organic volatile impurities
method IV |
Meets the requirement |
---------- |
| Sulphated ash |
---------- |
NMT 0.2 % |
Assay
(Sugar Content) |
NLT 62.5 %
NMT 91.5 % (on dried basis) |
NMT 92 %
(on dried basis) |
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4
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