LACTOSE
MONOHYDRATE
Free flowing and highly compressible powders for wet/dry granulation, capsules and sachets manufacturing.
EXCIPRESS™
Granulated and Spray dried lactose for Direct Compression, combining high compressibility & flowability.
EXCIPURE™
A range of lactose grades from coarse crystals to fine powders for Dry Powder Inhalers.
| TEST | TEST LIMITS | METHOD OF ANALYSIS |
|---|---|---|
| Appearance | White crystalline powder | Connect to download |
| Solubility | Freely soluble in water | Connect to download |
| Infrared absorption spectophotometry | Spectrum similar to CRS spectrum | Connect to download |
| Water | 4.5% to 5.5% | Connect to download |
| Appearance of solution | Clear and not more intensely coloured than BY7 | Connect to download |
| Acidity or alkalinity | ≤ 0,4 ml NaOH 0,1M | Connect to download |
| Specific optical rotation | +54,4 to +55,9 (anhydrous substance) | Connect to download |
| Absorbance: proteins and light-absorbing impurities | [A] 1% 1cm at 210 to 220 nm max 0.25 [A] 1% 1cm at 270 to 300 nm max 0.07 [A] 1% 1cm at 400 nm max 0.04 | Connect to download |
| Heavy metals | max. 5 ppm | Connect to download |
| Water | 4.5% to 5.5% | Connect to download |
| Residue on igniton/Sulphated Ash | max 0.1% | Connect to download |
| Loss on drying | max 0.5% | Connect to download |
| Particle Size Distribution 150M | Connect to download | |
| Total aerobic microbial count (TAMC) | max 100 CFU/g | Connect to download |
| Total yeast and moulds count (TYMC) | max 50 CFU/g | Connect to download |
| Escherichia Coli | neg. In 1 g | Connect to download |
| Salmonella | neg. In 10 g | Connect to download |
| TEST | TEST LIMITS | METHOD OF ANALYSIS |
|---|---|---|
| Appearance | White crystalline powder | Connect to download |
| Solubility | Freely soluble in water | Connect to download |
| Infrared absorption spectophotometry | Spectrum similar to CRS spectrum | Connect to download |
| Water | 4.5% to 5.5% | Connect to download |
| Appearance of solution | Clear and not more intensely coloured than BY7 | Connect to download |
| Acidity or alkalinity | ≤ 0,4 ml NaOH 0,1M | Connect to download |
| Specific optical rotation | +54,4 to +55,9 (anhydrous substance) | Connect to download |
| Absorbance: proteins and light-absorbing impurities | [A] 1% 1cm at 210 to 220 nm max 0.25 [A] 1% 1cm at 270 to 300 nm max 0.07 [A] 1% 1cm at 400 nm max 0.04 | Connect to download |
| Heavy metals | max. 5 ppm | Connect to download |
| Water | 4.5% to 5.5% | Connect to download |
| Residue on igniton/Sulphated Ash | max 0.1% | Connect to download |
| Loss on drying | max 0.5% | Connect to download |
| Total aerobic microbial count (TAMC) | max 100 CFU/g | Connect to download |
| Total yeast and moulds count (TYMC) | max 50 CFU/g | Connect to download |
| Escherichia Coli | neg. In 1 g | Connect to download |
| Salmonella | neg. In 10 g | Connect to download |
| TEST | TEST LIMITS | METHOD OF ANALYSIS |
|---|---|---|
| Appearance | White crystalline powder | Connect to download |
| Solubility | Freely soluble in water | Connect to download |
| Infrared absorption spectophotometry | Spectrum similar to CRS spectrum | Connect to download |
| Water | 4.5% to 5.5% | Connect to download |
| Purity (HPLC) | >99,7% | Connect to download |
| Water | 4.5% to 5.5% | Connect to download |
| Loss on drying | max 0.5% | Connect to download |
| Specific optical rotation | +54,4 to +55,9 (anhydrous substance) | Connect to download |
| Sulphated Ash | max 0.1% | Connect to download |
| Absorbance: proteins and light-absorbing impurities | [A] 1% 1cm at 210 to 220 nm max 0.25 [A] 1% 1cm at 270 to 300 nm max 0.07 [A] 1% 1cm at 400 nm max 0.04 | Connect to download |
| Appearance of solution | Clear and not more intensely coloured than BY7 | Connect to download |
| Acidity or alkalinity | ≤ 0,4 ml NaOH 0,1M | Connect to download |
| Heavy metals | max. 5 ppm | Connect to download |
| Total aerobic microbial count (TAMC) | max 10 CFU/g | Connect to download |
| Total yeast and moulds count (TYMC) | max 10 CFU/g | Connect to download |
| Escherichia Coli | neg. in 10 g | Connect to download |
| Salmonella | neg. in 10 g | Connect to download |
| Bile tolerant gram negative bacteria | Absence/ 10 g | Connect to download |
| Staphylococcus aureus | Absence/ 10 g | Connect to download |
| Pseudomonas aeruginosa | Absence/ 10 g | Connect to download |
| Burkholderia cepacia | Absence/ 10 g | Connect to download |
| Endotoxins | ≤5 EU/g | Connect to download |
