PharmaCore® - GMP Facility

GMP Analytical:Raw Material Testing

PharmaCore offers analytical testing of raw materials to the pharmaceutical industry. Let us help you in releasing your raw materials for production purposes or in qualification of your vendors. Our experienced scientists can perform testing in accordance with USP/NF and other compendia, ACS and FCC methodologies and monographs, as well as in compliance with methods you or your vendor provide.

We offer the following USP chapter test capabilities:

Identification Tests

181 Identification - Organic Nitrogenous Bases
191 Identification Tests - General
197 Spectrophotometric Identification Tests
201 Thin-layer Chromatographic Identification Test

Limit Tests

211 Arsenic
221 Chloride and Sulfate
231 Heavy Metals (I and II only)
241 Iron
251 Lead
261 Mercury (Method I only)
271 Readily Carbonizable Substances Test
281 Residue on Ignition

Other Tests and Assays

301 Acid-Neutralizing Capacity
341 Antimicrobial Agents - Content (GC Methods only)
401 Fats and Fixed Oils
451 Nitrite Titration
466 Ordinary Impurities
467 Residual Solvents

Physical Tests and Determinations

631 Color and Achromicity
641 Completeness of Solution
731 Loss on Drying
733 Loss on Ignition
741 Melting Range or Temperature
791 pH
921 Water Determination (Methods Ia, Ib, and III only)

Additional test capabilities include:

Chromatographic assays (HPLC and GC)
FTIR Spectroscopic analysis
Differential Scanning Calorimetry (DSC)
Titrimetry

PharmaCore's scientists bring a wealth of real-world experience to the table to help meet your needs. Our analytical operations are based on written, detailed SOPs and stringent quality assurance practices, and all of our work is performed in compliance with cGMP requirements.

We welcome client visits or audits to verify our strict compliance with current GMP requirements and to demonstrate the experience of our scientists.

For more information on our method development and validation capabilities or any of our pharmaceutical capabilities, please call PharmaCore at 336-841-5250, extension 159 (Mark Shapiro, Director GMP Analytical) or extension 101 (Kelly Tilyard, Marketing Manager).