|
ITEMS
|
SPECIFICATIONS
|
|
Description
|
White to white creamed
powder odorless or practically odorless
|
|
Identification
|
Positive
|
|
Clarity of Solution
(C = 2.5% w/v in
water)
|
n.m.t. ref. sol. II (Ph. Eur. III)
|
|
Color of Solution
(C = 2.5% w/v in
water)
|
n.m.t. ref. sol. B9 (Ph. Eur. III)
|
|
Water Content (by K.F.)
|
7.0% Max.
|
|
Specific Optical
Rotation
(C = 1% w/v in water)
|
+ 28.0°
to + 31.0°
(o.d.b.)
|
|
Assay (on dry basis)
|
98.5 – 101.0%
|
|
Residue on Ignition
|
12.5% - 14.0%
|
|
Heavy Metals
|
20 ppm Max.
|
|
Related Substances (by TLC):
|
|
|
Sodium Cholate
|
1.0% Max.
|
|
Sodium
Glycodeoxycholate
|
0.3% Max.
|
|
Sodium
Glycilglycocholate
|
1.0% Max.
|
|
Glycine
|
0.5% Max.
|
|
Other Unidentified
Related Substances (total)
|
0.5% Max.
|
