ACTA Laboratories, Inc.

ACTA Laboratories, Inc. is a cGMP FDA Registered Testing Laboratory that performs HPLC analyses on Pharmaceutical APIs (Active Pharmaceutical Ingredients) and Drug Products. ACTA can follow USP, BP, JP, and EP methods or develop methods of analysis for your API or Drug Product. ACTA can perform Method Validation and Verification to meet strict FDA regulatory requirements.
ACTA has the following detection capabilities:

• UV/Visible absorbance
  
• Photo Diode Array
  
• Refractive Index
  
• Conductivity
  
• Fluorescence
  
• Post-Column Derivatization
  

What is HPLC?

HPLC (High Pressure Liquid Chromatography), also know as LC (Liquid Chromatography) is a separation technique based on a solid Stationary Phase and a liquid Mobile Phase. Stationary Phase is the packing material contained in the HPLC column (hollow tube containing particles). Mobile Phase is the solvent or mixture of solvents (and sometimes other ingredients) that is passed through the HPLC column to flush the compounds through the column. Different compounds have different affinities that are attracted to the particles in the HPLC column and different affinities to being flushed through the column using the mobile phase. The competition between a compound’s affinity to stick to the stationary phase or get flushed away in the liquid mobile phase is what enables the separation. A mixture of different compounds can be separated by chromatography and then detected individually by a detector (e.g. UV Absorbance). The absorbance response for the separated compound will be proportional to the concentration of the compound in solution. Comparison of the detector response for an unknown to that of a known standard (known concentration of a pure compound) can determine the concentration present in the unknown. The analytes (compound you are testing the sample for) of interest must be dissolved in a solvent to perform an HPLC separation.

ACTA Laboratories, Inc. is a cGMP FDA Registered Testing Laboratory that performs GC analyses on Pharmaceutical APIs (Active Pharmaceutical Ingredients) and Drug Products. ACTA can follow USP, BP, JP, and EP methods or develop methods of analysis for your API or Drug Product. ACTA can perform Method Validation and Verification to meet strict FDA regulatory requirements.
ACTA has the following injection capabilities:

• Liquid Injector (for direct injection of liquids)
  
• Headspace Injector (Sample sealed in a vial and heated, headspace gas in the vial is injected)
  
• Gas Sampling Valve (for testing of gas samples in a cylinder or sampling bag)
  

ACTA has the following detection capabilities:

• FID (Flame Ionization Detector)
  
• TCD (Thermal Conductivity Detector)
  

What is GC?

GC (Gas Chromatography) is a separation technique based on a solid Stationary Phase and a gas Mobile Phase. There are 2 types of GC columns, Packed Column and Capillary Column. A Packed column has the Stationary Phase in the form of particles packed into a column (hollow tube containing particles). A Capillary Column has a long capillary (narrow bore tube) with the Stationary Phase is coated onto the inner surface of the capillary. The Mobile Phase is also referred to as the carrier gas (typically nitrogen or helium). Adjusting the temperature of the column (contained in an oven) adjusts how quickly the compounds pass through the column. The sample is injected into the GC injector (heated tube) and the volatile compounds are volatilized into gaseous compounds. The volatilized sample is then flushed into the column using the carrier gas. Different compounds have different affinities to be attracted to (stick to) the particles in the GC column and different affinities to being flushed through the column using the mobile phase. The competition between a compound’s affinity to stick to the stationary phase or get flushed away in the liquid mobile phase is what enables the separation. A mixture of different compounds can be separated by chromatography and then detected individually by a detector (e.g. FID). The detector response for the separated compound will be proportional to the concentration of the compound in solution. Comparison of the detector response for an unknown to that of a known standard (known concentration of a pure compound) can determine the concentration present in the unknown.
Components of a GC System (in order):

• Carrier Gas with Flow Controller – Gas delivery system that flushes Carrier Gas through the GC system
  
• Injector – injects a small quantity of a sample or standard solution (or gas) into the column
  
• Column – a hollow tube filled with porous packing material or coated with stationary phase
  
• Detector – instrument that monitors the gas exiting the GC column and will respond to the compounds of interest in the analysis
  
• Computer System with Chromatography Software – turns detector response into numerical result to determine concentration of each analyte
  

ACTA Laboratories, Inc. is a cGMP FDA Registered Testing Laboratory that performs ICP-MS analyses on Pharmaceutical APIs (Active Pharmaceutical Ingredients) and Drug Products. ACTA can follow USP, BP, JP, and EP methods or develop methods of analysis for your API or Drug Product. ACTA can perform Method Validation and Verification to meet strict FDA regulatory requirements.

What is ICP-MS?

ICP-MS (Inductively Coupled Plasma Mass Spectrometry) is an analytical technique that analyzes for metals in solution at concentrations as low as ppb levels (part per billion or nanogram / mL) in solution. The metals must be in solution (typically dissolved in acid) for analysis. An inductively coupled plasma is a plasma that is ionized (energized) by inductively heating the gas with an electromagnetic coil, and contains enough ions and electrons to make the gas conductive. The plasma is sustained in a torch with argon gas. Most metals end up as single charged ions in the plasma. These ions are then pulled by vacuum into a mass spectrum detector. Since each metal has unique atomic masses, the number of ions detected at a particular mass will be proportional to the concentration of that specific metal. Comparison of the detector response for an unknown to that of a known standard (known concentration of a pure metal) can determine the concentration present in the unknown.

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

ACTA performs cGMP method validation 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 requirements of the FDA. Parameters normally validated are accuracy, precision, specificity, limit of detection, limit of quantitation, linearity, range and robustness.

ACTA Laboratories performs AET on various pharmaceutical and cosmetic products in compliance with USP and EP requirements.

ACTA Laboratories specializes in USP raw material and finished product testing.

ACTA Laboratories specializes in USP raw material and finished product testing.

ACTA Laboratories routinely analyzes for objectionable microorganisms listed in USP <62>.

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