Specifications
Porous, powder, weakly acidic, H+ form, stabilization of Vitamin B12
Seplife® LPF 851 is a low-crosslinking, porous, weakly acidic, cation exchange resin, copolymerized with
methacrylic acid-divinylbenzene.
It is an insoluble and supplied as a dry, fine powder, which is suitable for use in pharmaceutical
applications, primarily as a carrier for certain basic (cationic) drugs and related substances as a
sustained release drug. It is also used to mask objectionable tastes associated with certain basic drugs.
Commercial examples of its use include:
Stabilization of Vitamin B12
Sustained Release of Nicotine
| Item |
Index |
| Matrix Structure |
Divinylbenzene-methacrylic acid |
| Ionic form |
H+ |
| Physical Appearance |
White to off white fine powder free of foreign matter and any
agglomeration |
| Particle size |
| %>150μm |
≦1 |
| %> 75μm |
18-30 |
| %< 50μm |
≦70 |
| Mass exchange capacity (mmol/g, on dried basis) |
≧10 |
| Water content % |
<10 |
| Water extractable impurities % |
≦2 |
| pH |
6-9.5 |
| Inorganic ion content |
| Sodium content (%, on dried basis |
≦0.2 |
| Heavy metals content (%) |
≦0.001 |
| Iron ion content (%) |
≦0.01 |
| Organic content |
| Methacrylic acid content(ppm) |
≦300 |
| Divinylbenzene content (ppm) |
≦1.0 |
| Naphthalene content (ppm) |
≦20 |
| Unknown single impurity (ppm) |
≦1.0 |
| Total unknown impurity (ppm) |
≦3.0 |
| Microbial purity |
| Total bacterial count (cfu/g) |
≦100 |
| Total mold count (cfu/g) |
≦100 |
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