EXCIPURE™ DPI 223

1 of 4 products in this brand
EXCIPURE™ DPI 223 is a finely milled cohesive lactose powder.

Chemical Name: Lactose

Functions: Carrier

Certifications & Compliance: EXCiPACT, European Pharmacopeia (Ph. Eur.), GMP, ISO 9001, Japan Pharmacopeia (JP), National Formulary (NF), United States Pharmacopeia (USP)

Dosage Form: Inhalers

Safety Data Sheet
  • TypeDocument Name
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Knowde Enhanced TDS

Identification & Functionality

Chemical Name
Pharma & Nutraceuticals Functions
CAS No.
63-42-3
EC No.
200-559-2

Features & Benefits

Benefit Claims

Applications & Uses

Dosage Form

Properties

Physical Form
Appearance
White crystalline powder
Soluble in
Water
Insoluble in
Ethanol (96%)
Specifications
ValueUnitsTest Method / Conditions
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 BacteriaAbsentper 10g
Burkholderia CepaciaAbsentper 10g
Endotoxins Contentmax. 5EU/g
Escherichia ColiNegativein 10g
Heavy Metalsmax. 5ppmUSP
Loss on Dryingmax. 0.5%
Particle Size Distribution (X₁₀)4 - 10µmLaser Diffraction Sympatec, Dry Dispersion
Particle Size Distribution (X₅₀)35 - 65µmLaser Diffraction Sympatec, Dry Dispersion
Particle Size Distribution (X₉₀)110 - 160µmLaser Diffraction Sympatec, Dry Dispersion
Pseudomonas AeruginosaAbsenceper 10g
Puritymin. 99.7%HPLC
Residue on Ignition / Sulphated Ashmax. 0.1%
SalmonellaNegativein 10g
Specific Optical Rotation (at [α] 20D, Anhydrous Substance)54.4 - 55.9degree
Staphylococcus AureusAbsentper 10g
Total Aerobic Microbial Countmax. 10CFU/g
Total Yeast and Molds Countmax. 10CFU/g
Water Content4.5 - 5.5%KF Method

Regulatory & Compliance

Residual Solvents

No class 1, 2, 3 solvents are used during production. (CPMP/ICH/283/95 + CVMP/VICH/502/99)

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

Technical Details & Test Data

Particle Size Distribution

PSD (Laser diffraction
Sympatec, dry dispersion)
Specifications (μm)
X10 4 to 10
X50 35 to 65
X90 110 to 160
SSA 0.8 m2/g

X10 : 6 μm | X50 : 48 μm | X90 : 142 μm *

*PSD laser diffraction (Sympatec, dry), indicative.

PSD Comparison (Laser diffraction, Sympatec, Dry Dispersion)

EXCIPURE™ DPI 223 - Psd Comparison (Laser Diffraction, Sympatec, Dry Dispersion)

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

Packaging & Availability

Packaging Type

Storage & Handling

Shelf Life
12 Months
Storage Information

Store in original unopened packaging, in a dry and odor free place.