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Lactose (for injection)
- Product description
- Product Description
- Lactose for inhalation and lactose for injection are a sieved crystalline lactose for dry powder inhalation and for injection.
- Compared with ordinary lactose, it has more strict control on impurity absorbance, protein, microorganisms and bacterial endotoxin to ensure the requirements of dry powder inhalation.
Application Range- Thinner for powder inhalers
- Freeze-dried preparation excipient
Product Advantages- Has a smooth surface and a narrow particle size distribution
- Excellent fluidity and physical and chemical stability
- With lower impurities and protein residues, more stringent microbial and bacterial endotoxin control
LimitGedian Renfu medicine auxiliary inhalation lactoseImpurity absorbance400nm (0.1g/ml) does not exceed 0.04
270-300nm (0.1g/ml) without regulations
210-220nm (0.01g/ml) does not exceed 0.25
270-300nm (0.01g/ml) does not exceed 0.070.008
0.027
0.032
0.002Protein0.02%<100ppmMicroorganismTotal bacteria 100, mold/yeast 10not detectedBacterial endotoxin<5 EU/g<5 EU/gLactose (for inhalation) absorbance diagramPrecautions- Lactose and primary amine compounds can undergo Maillard condensation reaction to form brown product
- Lactose has incompatibility with amino acids, aminophylline, amphetamine and lisinopril
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