SORA Labs is a full-service analytical chemistry and microbiology testing lab, utilizing testing methods from the USP, FCC, BP, AOAC and other compendia. We act as a testing branch for ingredient suppliers and manufacturers quality control departments. With our ISO 17025:2005 Accreditation and ISO 9001 Certification you can be confident that we meet proficiency guidelines for testing accuracy that gives you peace of mind in the quality of your products.
A primary requirement for FDA GMP compliance is identity You must prove that you are using the correct ingredient or component before manufacturing with it. We offer botanical, vitamins, mineral and other ingredient tests using TLC, FTIR, HPLC, Wet Chemistry methods and more, to help your company be in compliance with identity testing requirements.
We are continually updating and expanding our microbiology department for more testing capacity and efficiency. Our methods include USP, FDA Bacteriological Analytical Manual (BAM) and AOAC. With the addition of the BioLumix System we can now offer rapid micro screening. We can complete a micro screen, including yeast and mold, in 48 hours instead of the usual 6 day turn-around-time! The other advantage of the BioLumix System is that it is validated to the USP for dietary supplement ingredients. Screening your products for microbiology contaminants with raw material testing and throughout the manufacturing process will give you confidence in a safe finished product.
We offer chemical marker testing for botanicals, vitamin content, along with label claim testing for active ingredients and much more. We have developed and been recognized for a method to screen for chloramphenicol in the enzyme matrix using HPLC-MS. This method was selected for presentation at the North American Residue Conference. It is an honor for our lab to be recognized for this method development accomplishment.
PPSL testing, following USP <2250>, gives you testing information about the irradiation levels of your products. The FDA requires proper labeling of material that has went through an irradiation step to kill harmful microorganisms. This testing determines if your material has been put through the irradiation process and can be labeled properly.
There are many physical tests that can be done to give you full certificate of analysis details such as Bulk Density, Loss of Drying, Melting Point and Disintegration to name a few.
ICP and ICP-MS can be used for mineral potency and for testing residual heavy metal contamination levels. It is important to test for heavy metals because high levels of arsenic, cadmium, mercury or lead can potentially cause health problems or even poisoning. These minerals should be avoided in products that will ultimately be ingested.
Another requirement of the FDA GMP is to prevent contamination of the finished product. Monitoring the heavy metal levels of the ingredients being used, will ensure that the finished product is free of this contamination. Heavy metals often come from the soil or ground and natural products need to be monitored closely because of this.
GC, GC-MS and GC-FID can be used to test for pesticide residue, residual solvents and even active chemical markers in products. We follow the USP <561> for pesticide residue USP <467> for residual solvents These screening methods also help you comply with FDA GMP requirements for avoiding contamination of your finished product.
Enumeration methods that are routinely tested include:
• Anaerobic or Aerobic incubation methods
• Spore forming bacteria enumeration using sonification or additional mixing steps to break the spores
Strain examples include:
Probiotic Assays (PDF)
These technique-driven methods take years of experience to develop accurate and repeatable results. With over 20 years performing these methods, we have an excellent reputation for accuracy. The US Pharmacopeia has requested our input, many times throughout the years, to test and verify the activity value of certain enzyme reference standards that are used in their methods.