EXCIPURE™ DPI 223
EXCIPURE™ DPI 223 is a finely milled cohesive lactose powder.
Properties
- Physical Form
- Powder
- Solid
- Pharma and Nutraceuticals Functions
- Carrier
Product families
Applications
- Nasal
Product Families
- Carriers & Bulking Agents
Other characteristics
- Brand
- EXCIPURE
- Functions
- Carrier
- Dosage Form
- Inhalers
- Certifications & Compliance
EXCiPACT, European Pharmacopeia (Ph. Eur.), GMP, ISO 9001, Japan Pharmacopeia (JP), National Formulary (NF), United States Pharmacopeia (USP)
- Grade
- Pharma Grade
- Markets
- Healthcare & Pharma
- Appearance
- White crystalline powder
- Shelf LIfe
- 12 Months
- Soluble In
- Water
- Insoluble In
- Ethanol (96%)
- Technology
- Pharmaceuticals & Nutraceuticals
- Benefit Claims
- Excellent Flowability
- Certifications
- EXCIPACT certified (GMP)
- ISO 9001 and ISO 22000 certified
- Following IPEC cGMP
- On-site Batch testing & Batch release
- Certified animal Rennet-free raw materials
- Packaging Type
- Bags
- Residual Solvents
No class 1, 2, 3 solvents are used during production. (CPMP/ICH/283/95 + CVMP/VICH/502/99)
- Storage Information
Store in original unopened packaging, in a dry and odor free place.
- Particle Size Distribution
X10 : 6 μm | X50 : 48 μm | X90 : 142 μm *; *PSD laser diffraction (Sympatec, dry), indicative.
- Certifications and Compliance
- EXCiPACT
- European Pharmacopeia (Ph. Eur.)
- GMP
- ISO 9001
- Japan Pharmacopeia (JP)
- National Formulary (NF)
- United States Pharmacopeia (USP)
- Product Customization Possibilities
Particle size/shape/surface customization through process adjustment; Blending of several products; Joint product development; Functionality related characteristics testing; Low, medium and high volume manufacturing scales; Additional microbial & physical properties testing; Packaging in cartons drums/Plastic boxes/Carton with aluminum foil
Technical data
Table 1 of 1
22 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| Absorbance (Proteins and Light Absorbing Impurities, [A] 1%, 1 cm at 210 to 220 nm) | max. 0.25 | — | — |
| Absorbance (Proteins and Light Absorbing Impurities, [A] 1%, 1 cm at 270 to 300 nm) | max. 0.07 | — | — |
| Absorbance (Proteins and Light Absorbing Impurities, [A] 10%, 1 cm at 400 nm) | max. 0.04 | — | — |
| Acidity or Alkalinity (at ml 0.1 M NaOH) | max. 0.4 | — | — |
| Bile Tolerant Gram Negative Bacteria | Absent | per 10g | — |
| Burkholderia Cepacia | Absent | per 10g | — |
| Endotoxins Content | max. 5 | EU/g | — |
| Escherichia Coli | Negative | in 10g | — |
| Heavy Metals | max. 5 | ppm | USP |
| Loss on Drying | max. 0.5 | % | — |
| Particle Size Distribution (X₁₀) | 4 - 10 | µm | Laser Diffraction Sympatec, Dry Dispersion |
| Particle Size Distribution (X₅₀) | 35 - 65 | µm | Laser Diffraction Sympatec, Dry Dispersion |
