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Pharmaceutics International, Inc.
10819 Gilroy Road
Hunt Valley, MD 21031
410-584-0001
Fax: 410-584-0007
Business Development

Analytical Services

PII’s analytical services fully support formulation development and manufacturing at a ratio of four to one analytical chemists to formulators.


The analytical group has extensive experience with method development for challenging compounds. For example, Refractive Index (RI) or Evaporative Light Scattering detectors (ELS) are used for the quantitation of compounds without chromophores. PII also has experience in method development for controlled, delayed and immediate release products for a variety of compounds.

PII Analytical services include testing of:
Excipients (USP, EP and JP)
Active Pharmaceutical Ingredient (API)

Key Capabilities
HPLC
GC
Dissolution / Disintegration
Ultraviolet Spectrophotometry
Thin Layer Chromatography

Finished product
Packaging Components

Titrations
Total Organic Carbon (TOC)
Differential Scanning Calorimetry (DSC)
Fourier Transform Infrared Spectrophotometry (FTIS)
Polarimetry
Analytical Method Development & Validation
Analytical methods are developed and validated to support formulation development, in-process and release testing of finished products and stability programs.

Dissolution Method Development & Validation
The analytical group is capable of developing dissolution methods for all dosage forms using USP apparatus I, II or III. Methods are developed for controlled, delayed and immediate release products. Dissolution samples are analyzed by chromatographic or spectrophotometric techniques.

Assay/Impurities Method Development & Validation
Stability indicating and specific methods are developed at PII to perform assay testing of active compound and impurities in API and finished product.

Residual Solvent Testing
PII develops and validates methods for residual solvents in both API and drug products using GC with direct injection or headspace.

Cleaning Method Development & Validation
All compounds in the development process have a validated cleaning method developed at PII. This enables cleaning verification to be performed on all manufacturing equipment. Cleaning validation is performed during the production of validation batches using a customer-approved protocol.
  
Stability Testing
Following ICH guidelines, PII performs stability testing using a range of upright and walk-in chambers on both API and drug product in bulk and final packaging. PII has chambers for the following conditions:
5°C, 25°C/60%RH, 30°C/60%RH, 30°C/65%RH and 40°C/75%RH and custom conditions.

 

Pharmaceutics International, Inc.
10819 Gilroy Road, Hunt Valley, MD 21031
Phone: 410 584-0001 Fax: 410 584-0007
www.pharm-int.com
Mission Statement: To deliver a quality dosage form development service which meets all of our customers’ needs in a timely fashion