|
S.NO |
TECHNIQUE
I.P/B.P/J.P/U.S.P |
SPECIFICATION
- I.P / B.P |
SPECIFICATION
- J.P / U.S.P |
| 1. |
Description |
White
or Crystalline powder;
Odourless, taste slightly sweet. |
White
or Crystalline Powder ;
Odourless, taste. |
| 2. |
Solubility |
Satisfactory |
Satisfactory |
| 3. |
Identification
(B & C)-I.P (B,C,D)-B.P 3 - J.P /
U.S.P |
Satisfactory |
Satisfactory |
| 4. |
Purity
- J.P / U.S.P |
|
|
| 5. |
a)
Acidity |
NMT
0.4 ml of 0.1 M NaoH
required |
NMT
0.4 ml of 0.1 M NaoH
required |
| 6. |
b)
Clarity, Color, Odour of Solution. |
Clear
and not intensly colored than reference solution BY S7 |
Clear
and Colourless. Absorbance at 400 nm should not more than
0.04 |
| 7. |
c)
Specific Optical Rotation. |
+54.4
degree to +55.9 degree (dry basis) |
+54.4
degree to +55.9 degree (dry basis) |
| 8. |
d)
Light Absorbtion. |
|
|
| |
1g
in boiling water
Aborp. at 400nm - I.P |
NMT
0.04 |
---- |
| |
Absorp.
At 210 - 220 nm |
NMT
0.25 |
NMT
0.25 |
| |
Absorp.
At 270 - 300 nm |
NMT
0.07 |
NMT
0.07 |
| |
c)
Heavy Metal |
NMT
5 PPM |
NMT
5 PPM |
| 9. |
Arsenic.
- I.P |
NMT
1 PPM |
---- |
| 10. |
Loss
of Drying - J.P / U.S.P |
---- |
---- |
| 11. |
Sulphated
Ash |
NMT
0.1 % |
---- |
| 12. |
Water |
4.5
to 5.5 % w/w |
4.5
to 5.5 % w/w |
| 13. |
Residue
of Ignition. |
---- |
NMT
0.1 % |
| 14. |
Microbial
Limits |
|
|
| |
Tot.
Microbial Count - I.P |
NMT
100 cfu / gm |
---- |
| |
Tot.
Viable Aerobic Count
- B.P/J.P/U.S.P |
NMT
100 cfu / gm - B.P |
NMT
100 / gm |
| |
Escherichia
coli |
Negative
/ gm |
Negative
/ gm |
| |
Tot.
Fungi and Yeast |
---- |
NMT
50 / gm |
| |
Salmonella.
- I.P/J.P/U.S.P |
Negative
/ gm |
Negative
/ gm |
