Capabilities & Services

Natoli Scientific is 14,000 sq. ft. facility located at Telford, PA. We are equipped with the ‘state-of-the-art’ equipment required for your preformulation studies, formulation development, formulation troubleshooting, and start-up manufacturing needs.

Our dedicated scientist team has expertise in handling dynamic and complex issues of powder mechanics. Natoli Scientific’s on-site analytical capabilities expand from basic to advanced powder micrometrics characterization, Compaction simulation or emulation, USP <1062>, solid orals quality control testing, and informal and ICH stability studies.

Analytical Capabilities

On-Site Analytical Capabilities:

Powder Micromeritics:

Density Measurements:
- Bulk and Tapped density measurement
- Helium pycnometer
Granule Characterization:
- Particle size and distribution measurement (Sieve analysis: d10, d50, d90)
- Moisture analyzer (Loss on drying)
Powder Flow Measurements:
- FT4 powder rheometer
- Angle of repose

USP <1062>:

Basic Compression Studies [USP<1062>]:
- Natoli RD 10

Compaction Simulation/Emulation:

Compaction Testing Characterization:
Advanced Compression Studies:
- Presster compaction emulator

Batch/Lot Testing for Release:

Tablet breaking force (hardness) tester
Tablet friability testing
Tablet disintegration testing
Tablet dissolution testing

Analytical Method Development and Validation:

HPLC method for API characterization and quantification
Developing discriminatory dissolution media
Tablet dissolution testing
- pH meter
- Agilent HPLC

Stability Studies:

Informal stability studies
Forced degradation studies
Accelerated stability studies
Beyond use or expiration date
- Two dedicated ICH stability chambers (Humidity and Temperature controlled)

Additional Analytical Capabilities:

We offer various highly advanced analytical testing for complete pharmaceutical material characterization (API and excipients) with our partner labs.

Rigaku Smartlab Full Featured Laboratory System Powder X-Ray Diffractometer
Tablet CT-Scan Topography
Q2000 high sensitivity DSC Thermal Analysis Instrument
Q5000 high sensitivity TGA Thermal Analysis Instrument
Q5000 SA Dynamic Moisture Sorption Analyzer
Malvern Mastersizer 3000 with Dry Powder Feeder Particle Sizer (d10, d50, d90)
Texture Analyzer
Karl Fisher Titration (Water content)
PerkinElmer^® ATR-FTIR
Zetasizer Nano ZS
Shimadzu UV-1240 UV Spectrophotometer

Lab-Scale Manufacturing Capabilities:

Blending:

V-blender (2-quart, 4-quart, 1 cu.ft., 5 cu.ft.)

Wet Granulation:

High shear granulator
(Manufacturer: Diosna, Model: P 1-6)
Low shear granulator
Fluid bed granulator
(Manufacturer: Diosna, Model: Minilab RC)

Dry Granulation:

Roller compactor
(Vector)

Spray-Dryer:

Buchi

Milling:

(Manufacturer: Frewitt)
Oscillation mill (Model: Oscillowitt-Lab)
Hammer mill (Model: Hammerwitt-Lab)
Co-mill (Model: Coniwitt-Lab)

Tablet Manufacturing:

Natoli NP-RD 30 (4-station; B and D-tooling) with AIM Data Acquisition System

Tablet Coating:

Tablet coater (Manufacturer: Diosna, Model: Minilab RC)
Fluid bed coater for Minitabs, and Pellets (Manufacturer: Diosna, Model: Minilab RC)

Start-Up Manufacturing Capabilities: