ACTA uses ICP-MS to perform Prop 65 Lead Testing in accordance with the State of California Attorney General’s Testing Protocol.

 

ACTA also performs testing of other elemental impurities in Prop 65 using ICP-MS.

 

ACTA tests for residual Ethylene Oxide levels in ETO sterilized botanicals.

ACTA performs testing for minerals in raw materials and finished dosage forms down to ultra-trace levels using an Inductively Coupled Plasma Mass Spectrometer (ICP-MS).

ACTA performs testing for vitamins in raw materials and finished dosage forms using USP, AOAC, FCC, and methods developed at ACTA.

Oil-soluble Vitamins

• Vitamin A
• Vitamin D 
• Vitamin E
• Vitamin K 
• Beta Carotene

Water-soluble Vitamins

• Ascorbic Acid
• Biotin
• Cyanocobalamin
• Folic Acid
• Niacin
• Niacinamide
• Pantothenic Acid
• Pyridoxine Hydrochloride
• Riboflavin
• Thiamine

 

ACTA performs testing of botanicals and other nutritional ingredients in raw materials and finished dosage forms.

• Black Pepper (Piperine)
• Carnitine
• Choline 
• Coenzyme Q10
• Cranberry (Citric, Malic, Quinic acids)
• Dehydroisandrosterone (DHEA)
• Feverfew (Parthenolide)
• Fructooligosaccharides (1-kestose, Nystose, 1F-Fructofuranosylnystose)
• Ginkgo Biloba (Flavone Glycosides: Quercetin, Kaempferol, Isorhamnetin)
• Ginkgo Biloba (Terpene Lactones: Ginkgolide A, Ginkgolide B, Bilobalide)
• Ginseng (Total Ginsenosides)
• Inositol
• Lipoic Acid
• Melatonin
• Methylsulfonomethane (Dimethylsulfone)
• Pycnogenol (Proanthocyanidin Content)
• Pyruvic Acid
• Quercetin
• St. John’s Wort (Total Hypericins calculated as Hypericin)

 

ACTA performs dissolution and disintegration testing of Nutritional Supplements in accordance with USP <2040> Disintegration and Dissolution of Nutritional Supplements.

 

ACTA performs monograph testing of raw materials and finished products using the following compedia:

• United States Pharmacopeia (USP)
• Food Chemicals Codex (FCC)
• Official Methods of Analysis of AOAC International (AOAC)

 

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 microorganisms such as Pseudomonas cepacia and Klebsiella.

USP Antimicrobial Effectiveness Testing for evaluating preservative levels.

Total Coliforms per FDA BAM

Validation of Microbial Recovery per USP <1227>

USP Assay for Biotin Method 2

USP Assay for Cyanocobalamin, Method 2 (B12)

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. Using various Instrumentation, ACTA develops 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 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

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.