|
ITEMS |
SPECIFICATIONS
|
|
Description |
White or
nearly white crystalline powder
|
|
Identification |
Positive
(IR)
|
|
Clarity of Solution
(C =
9% w/v in water at pH 7.5)
|
n.m.t.
ref. Sol. I
(Ph. Eur.
IV)
|
|
Color of
Solution
(C = 9%
w/v in water at pH 7.5) |
Max.Y6 o
BY6
(Eur. Ph.
IV)
|
|
Clarity of
Solution
(C = 10%
w/v in methanol) |
n.m.t.
ref. Sol. I
(Eur. Ph.
IV)
|
|
Color of
Solution
(C = 10%
w/v in methanol)
|
Max. Y6 o
BY6
(Eur. Ph.
IV)
|
|
Water
Content (by K.F.) |
£
5 %
|
|
Specific
Optical Rotation
(C = 1% in
methanol) |
+31.5° ± 2°
|
|
Assay |
98.0 to
101.0 %
(dried
basis)
|
|
Residue on
Ignition |
≤
0.2%
|
|
Heavy
Metals |
£
10 ppm
|
|
Iron |
≤
10 ppm
|
|
Chloride |
≤
50 ppm
|
|
pH
(2g/40 mL
water suspension) |
3.0 – 4.0
|
|
Residual
Solvents: |
|
|
Ethanol
|
≤0.5%
|
|
Ethyl
Acetate |
≤100 ppm
|
|
Related
Substances by TLC: |
|
|
Cholic Acid |
£
0.5%
|
|
Glycodeoxycholic Acid |
£
1.0%
|
|
Ethyl
Glycocholate |
£
0.2%
|
|
Ethyl
Glycodeoxycholate |
£
0.2%
|
|
Ethyl
Cholate |
£
0.2%
|
|
Glycine |
≤
0.2%
|
|
Ethyl
Glycinate |
≤ 0.1%
|
|
Other
Unidentified Related Substances (Each) |
≤
0.2%
|
|
Other
Unidentified Related Substances (Total) |
≤
0.5%
|
|
Total Sum
Related Substances |
≤
3.0%
|
|
Microbiology: |
|
|
Aerobic
Organisms |
≤ 100 CFU/g
|
|
E. Coli |
Absent/10 g
|
|
Staph.
Aureus |
Absent/10 g
|
|
Pseudomonas |
Absent/10 g
|
|
Bacterial
Endotoxins |
≤0.2 EU/mg
|
|
Alfatoxins
B1
|
≤2.0 µg/Kg
|
|
Alfatoxins
B1+B2+G1+G2 |
≤4.0 µg/Kg
|
