Acceptance limit |
Reference |
Parameter |
.No |
---|---|---|---|
Colourless or Yellowish Liquid |
In House |
Appearance |
1 |
Conforms with standard |
In House |
Identity (NIR) |
2 |
5% ≥ |
In House |
Monomer content (Raman) |
3 |
% 9.0-11.0 |
In House |
Dry residue |
4 |
100-350mPa.s |
In House |
Viscosity |
5 |
500EU/mL ≥ |
In House |
Endotoxin |
6 |
Acceptance limit |
Reference |
Parameter |
.No |
---|---|---|---|
5.5 – 8.5 |
Ph Eur 8.0 (2.2.3) |
pH (at the time of prodoction) |
1 |
< 5 mL Clear suspension |
Ph Eur 8.0 |
Identity (NIR) |
2 |
10 mg/mL (9.0 - 11.0) |
Ph Eur 8.0 <2.4.17> |
Monomer content (Raman) |
3 |
≤ 0.33 % w/w |
h Eur 8.0 <2.4.4> |
Dry residue |
4 |
≤ 100 ppm |
Ph Eur 8.0 |
Viscosity |
5 |
≤ 50 ppm |
Ph Eur 8.0 <2.4.1> |
Endotoxin |
6 |
≤ 0.5 % w/w |
Ph Eur 8.0 <2.4.13> |
Sulfate |
7 |
≤ 1 ppm |
USP43-NF38 <233> |
Arsenic |
8 |
≤ 15 ppm |
Ph Eur 8.0 <2.4.9> |
Iron |
9 |
≤ 20 ppm |
Ph Eur 8.0 <2.4.8> |
Heavy Metals |
10 |
≤ 5 EU/mg Al |
Ph Eur <2.6.14> |
Bacterial Endotoxins |
11 |
Acceptance limit |
Reference |
Parameter |
.No |
---|---|---|---|
Agarose 4% |
In House |
Matrix |
1 |
Lentil Lectin |
In House |
Ligand |
2 |
1.8±0.1 mg Lentil lectin/ml medium |
In House |
Ligand density |
3 |
10-Mar |
In House |
pH stability, Operational |
4 |
~90 µm |
In House |
Particle size, d50V |
5 |
< 75 cm/h at 25 °C, HR 16/10 column, 5 cm bed height |
In House |
Max. Linear flow |
6 |
Stable to commonly used aqueous buffers. |
In House |
Chemical stability |
7 |
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