S. No. |
PARAMETERS |
SPECIFICATION |
01. |
Colour |
White |
02. |
Description |
Have to corresponds as USP26/NF21 |
03. |
Identification A,B,C |
Have to corresponds as USP26/NF21. |
04. |
Degree of Polymerization |
NMT 350 as USP 26/NF21 |
05. |
Assay (Dried) |
97.0% to 102%. |
06. |
PH |
5.0-7.5 as USP 26/NF21 |
07. |
Bulk Density |
0.26 to 0.32 g/ml. |
08. |
Water-Soluble substance |
NMT 0.24% as USP 26/NF21 |
09. |
Ether-soluble substance |
NMT 0.05% as USP 26/NF21 |
10. |
Loss on Drying |
NMT 6.0% as USP 26/NF21 |
11. |
Conductivity |
NMT 75 uS as USP 26/NF21 |
12. |
Heavy Metals |
NMT 10 ppm as USP 26/NF21 |
13. |
Residue on Ignition |
NMT 0.05% as USP 26/NF21 |
14. |
Organic Volatile Impurities |
Have to correspond as USP 26/NF 21 |
15. |
Sieve Analysis (%Retention)
60 Mesh
200 Mesh |
< 1.0%
< 30.0% |
16. |
Particle Size Distribution
D10
D50
D90 |
< 30u
40-60u
> 80 u |
|
MICROBIAL LIMITS |
|
01. |
Total Aerobic microbial Count |
NMT1000/g as USP26/NF21 |
02. |
Total Yeast & Mould Count |
NMT100g as USP26/NF21 |
03. |
Staphylococcus Aureus |
Absent as USP26/NF21 |
04. |
Escherichia Coli |
Absent as USP26/NF21 |
05. |
Pseudomonas Aeruginosa |
Absent as USP26/NF21 |
06. |
Salmonella Species |
Absent as USP26/NF21 |
