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Laboratory Profile: ACTA Laboratories, Inc.

ACTA Laboratories, Inc. Services :

FDA registered, cGMP, Pharmaceutical Testing, Nutritional Testing, Medical Device Testing, Botantical Testing, High Performance Liquid Chromatography (HPLC) UV/Visible absorbance Fluorescence Photo Diode Array Refractive Index Conductivity Post-Column Derivatization Ion Chromatography (IC) Gas Chromatography (GC) with Direct Injection and Headspace Injection (FID detection) Elemental Testing Equipment Inductively Coupled Plasma Mass Spectrometer (ICP-MS) Direct-Current Plasma Atomic Emission Spectrophotometer (DCP) Stability Chambers 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 setpoints. 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 ISO Accelerated Storage for Medical Devices 45° C / > 40% RH And at these conditions: 25° C / Ambient Humidity 40° C / Ambient Humidity 2 to 8° C

-20 to -10° C

UV/Visible Spectrophotometer (UV/Vis)

Fourier Transform Infrared Spectrophotometer (FTIR)

Fluorescence Spectrophotometer

Polarimeter, High sensitivity capable of all USP wavelengths (325, 365, 405, 436, 546, 577, and 589 nm)

Osmometer

Refractometer

Karl Fischer Titrator

Melting Point Apparatus

Brookfield Viscometer

Total Organic Carbon Analyzer (TOC Analyzer) Conductivity Meter

Ion Specific Electrode Meter

Dissolution Apparatus

Disintegration Apparatus

Light Obscuration Particle Counter (For USP<788>) General Microbiology Equipment Steam Sterilizer

Biological Safety Cabinet

Laminar Flow Hood

Microscope

Darkfield Colony Counter

Kinetic Colorimetric Bacterial Endotoxin Machine (LAL)

Contact

949-595-0641

949-595-0522

 Company Website

27082 Burbank Street

Foothill Ranch, CA US