ACTA Laboratories provides leading-edge consulting and analytical testing services to the pharmaceutical industry.  Services include: 

Chromatography	Method Validation
Elemental Testing	Stability Studies
Wet Chemistry	Microbiological Testing
Monograph Testing	Biological Tests
Method Development

ACTA uses many types of chromatography including:

• High Performance Liquid Chromatography (HPLC) with pre-column derivatization and post-column derivatization
• Ion Chromatography (IC)
• Size Exclusion Chromatography (SEC)
• Gas Chromatography (GC)
• Thin Layer Chromatography (TLC)
• Column Chromatography
• High Performance Liquid Chromatography coupled with an Inductively Coupled Plasma Mass Spectrometer (HPLC-ICP-MS)

ACTA performs testing for elemental impurities and active substances down to ultra-trace levels using an Inductively Coupled Plasma Mass Spectrometer (ICP-MS). Elemental speciation is also available via High Performance Liquid Chromatography coupled with an Inductively Coupled Plasma Mass Spectrometer (HPLC-ICP-MS).

ACTA performs all types of wet chemistry tests, including very technique sensitive tests.

ACTA does monograph testing of raw materials and finished products. See the list of USP General Chapter Tests offered. Testing is performed using the following compendia:

• USP
• BP
• EP
• JP
• AOAC
• ACS
• FCC

ACTA develops methods for non-compendial products and for compendial products that need stability indicating methods. ACTA's staff is experienced with method development for all types of dosage forms. Various Instrumentation is used to develop rugged and accurate methods to meet your requirements.

 

ACTA validates methods in accordance with USP and ICH requirements. ACTA prepares Validation Protocols for the study and will furnish you with a Validation Report that will meet the FDA’s expectations.

ACTA generates Stability Protocols for the study and tracks your samples carefully to ensure that they are tested in a timely manner.

ACTA has a standby generator that maintains power to the stability chambers in the event of a power failure and an alarm system that will page the Director of QA/QC in the event that any stability chamber fails to maintain its humidity or temperature set points. These controls ensure that stability samples will be stored as required.

Stability Chambers are maintained at the following conditions:

ICH Conditions:

• 25° C / 60% RH
• 30° C / 65% RH
• 40° C / 75% RH

And at these conditions:

• 2 to 8° C
• -25 to -10° C

We also provide custom temperature and humidity conditions based on your specific needs.

ACTA performs the following Microbiological Tests:

USP Microbiological Examination of Nonsterile Products

• Total Aerobic Microbial Count
• Total Combined Molds and Yeasts Count
• Screening for Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella, and Escherichia coli.

Screening for other objectionable microorganisms not included in the USP, such as Pseudomonas cepacia and Klebsiella.

USP Antimicrobial Effectiveness Testing

Total Coliforms per FDA BAM

Validation of Microbial Recovery per USP <1227>

ACTA performs the following Biological Tests

• USP <85> Bacterial Endotoxins Test
• USP <87> Biological Reactivity Tests, In Vitro
• Agar Diffusion Test
• Direct Contact Test
• Elution Test
• ISO 10993-5 Tests for In-vitro cytotooxicity
  • Agar Diffusion Test
  • Direct contact Test
  • Test on Extracts
• Inhibition of Cell Growth (ICG) test on aqueous extracts per FDA Guidelines