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Applications
Lacto-Sphere® MM50 is basic carrier for Dry
Powder Inhaler formulations.
Stability
Lacto-Sphere® MM50 has a minimum shelf life
of 24 months in unopened, original containers.
Storage
Lacto-Sphere® MM50 should be stored between
15°C and 25°C, below 60% relative humidity, with container
closed when not in use.
Packaging
Lacto-Sphere® MM50 standard packaging:
- 25 Kg in 60 L fiber drum , PE bag in alu bag with desiccant,
minimum order 25 kg
| Characteristics |
Specifications |
| Identification |
Complies to all Pharmacopoeia test |
| Appearance of solution |
Complies |
| Acidity or alkalinity |
<0.4mL 0.1 N NaOH/6 g |
| Specific optical rotation |
+54.4 - +55.9 |
| Absorbance |
≤ 0.04 at 400 nm (1g/10mL) |
| Protein/UV absorbing impurities |
≤ 0.25 between 210-220 nm (1g/100mL)
≤ 0.07 between 270-300 nm (1g/100mL) |
| Heavy metals |
≤ 5 ppm |
| Water |
4.5 - 5.5 % |
| Loss on drying |
≤ 0.5% (80°C/2h) |
| Sulphated ash |
≤ 0.1% |
Microbialcontamination
- total aerobic counts
- yeast and moulds
- E. coli
- S. aureus
- P. aeruginosa
- Salmonella
- Enterobacteriaceae |
≤ 10 cfu/g
≤ 5 cfu/g
not detectable in 10 g
not detectable in 10 g
not detectable in 10 g
not detectable in 100 g
not detectable in 10 g |
| Particle size
X90
X50
X10 |
90 - 220 µm
40 - 60 µm
10 - 20 µm
|
| Apparent density
- poured (about)
- tapped (about) |
0.62 g/mL
0.75 g/mL
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