Frequently Asked Questions

The timely reporting of Out of Specification (OOS) results can dramatically affect your bottom line. Analytical Resource Laboratories has a detailed strategy for handling OOS data. The first step is to decide if you would like to authorize ARL to retest OOS samples immediately or notify you of the discrepancy and wait for your authorization to do so. The benefit of selecting automatic retesting is that you (we) do not lose time, and retesting will be conducted quickly. The drawback to choosing automatic retesting is the potential of added expense should confirmatory results be determined. Of course, if the error is on our side, you will not be charged for the retest.

But let’s start from the beginning. When an analysis does not meet specifications, the analyst and the quality manager immediately affect an OOS investigation. This investigation determines if the correct sample was tested. Examples of questions detailed in the OOS report include; was the sample tested for the desired analyte? Was the correct method used? Were the standards up to date? We review every question on our OOS investigation report looking for errors that we may have caused. As much as we try to be perfect, humans are prone to error from time to time. Following the investigation, we either 1) immediately retest the sample in duplicate or 2) notify the submitting party of the OOS. The timeline of this process is so critical that we built automatic notifications into our LIMS. Notifications are submitted to the quality team for review and then sent to our partner by email the same day.

Should you have additional questions, please Chat with us today!

Good Manufacturing Practice guidelines require that a manufacturer ensure that product label claims are verifiable. We highly recommend that you refer to 21 CFR Part 111 regarding cGMP guidelines and requirements.

If a raw material does not have a testable marker detectable in the finished good by HPLC, GC, ICP, or other technologies, your Master Batch Record’s (MBR) will play a large role in verifying your label claims. In this case, properly testing the raw materials is essential. Each raw material received needs to be tested for actives as well as for purity by FTIR or HPTLC. Once you have determined that the raw material meets your specifications, the accuracy and traceability of your MBRs are critical. Should you be audited by the FDA, providing this information to them will be key to a successful audit.

Preservative Efficacy Testing, aka PETs or Challenge Testing, is performed to evaluate your product's antimicrobial properties. To perform this test, the lab introduces a known quantity of a known species of organism into the product and measures those organisms' viability over a 28 day period. A successful test will yield no less than a two-log reduction in counts from day zero (0) to day fourteen (14), and no increase in counts from day fourteen (14) to day twenty-eight (28).

While PET's are great at helping you understand your product's antimicrobial properties, this test is not a Stability Test or Shelf Life Test.

Stability and Shelf Life testing measures the concentration of the active ingredients in the product. It also monitors its organoleptic properties such as color, smell, taste, viscosity, appearance, and efficacy over time. This test is performed by collecting enough finished product samples for the duration of the testing, placing half of the samples in a stability chamber, set at 40 degrees C and 75% relative humidity. The other half of the samples are placed in a controlled environment mimicking the natural conditions of the target market in which the products are to be sold. The former is known as the accelerated shelf-life test, and the latter the real-time shelf-life test. A profile of physical characteristics and actives tests is conducted according to your label claims, at 0, 3, 6, 9, 12, 18. 24, and 36 months. The real-time samples are pulled according to these months, and the accelerated portion of the tests will occur based on the Arhenius formula, which dictates how many days in the chamber are equivalent to real-time days.

The purpose of the stability study is to learn how the product fairs over time and how long you can expect the product to meet its quality specifications.

When you submit a sample for analysis under a particular turnaround time, you expect your laboratory partner (ARL) to make every effort to meet this schedule. So, how are turnaround times measured, and why are results sometimes “late”? This article is intended to demystify turnaround times (TAT’s).

Let’s explore how we can work together to mitigate delays and risk:

1. ARL’s On-time Rating Is Greater Than 97.7%!

   We are very proud of our on-time rating, but we continually strive to do better.

2. Microbiology Testing Is Measured in Calendar Days

   Samples submitted for routine microbiological testing (Complete Micro Profiles by USP 2021/2022 and 61/62) constitute a large percentage of the testing that we perform at ARL. For more than 21 years, we have set up these samples the same day they are received by scheduling swing and night shift microbiology teams. Routine micro is measured in calendar days. Once the testing has begun, these living, breathing organisms do not care what day of the week it is; they just do their thing 7 days a week, and so must we. Please note that calendar days are measured in 24-hour periods. The day we received the sample is Day Zero; the next day is Day 1.

3. Chemistry Testing Is Measured in Business Days

   The turnaround times for samples received for analytical testing, such as HPLC, GC, ICP, etc., are measured in business days. Chemistry tests require the direct attention of an analyst throughout the testing process. For this reason, analyses are scheduled and batched so that they can run most efficiently. This efficiency allows us to reduce consumable costs and equipment usage times, which allows ARL to offer the most competitive pricing. Good efficiency equals quick TAT’s and cost savings.

   Our goal in the chemistry labs is to schedule analyses in such a way that the testing portion of the analysis is completed within a timeframe that allows sufficient time to conduct follow up testing, if necessary. This further allows time for quality review and verification of accuracy and method suitability. Please note that business days are measured in 24-hour periods, Monday to Friday. The day we received the sample is Day Zero, the next day is Day 1.

4. Special Projects and Samples Sent to Outside Labs

   The TAT for special projects, such as stabilities, method validations, suitabilities, or testing that we con not perform in-house, are discussed with our partners on a case-by-case basis according to current workloads, equipment availability, and personnel.

You may log in to our Laboratory Information Management System and see real-time data for your testing or contact a member of our Partnerships or Sample Management teams for assistance. Please send an email to info@yourqualitylab.com, call 801-847-7722, or Chat with us online.

ARL offers thousands of analyses, many of which can be tested in 1, 3, and 5-days. In times of critical urgency, we recommend calling one of our Partnership or Sample Management team members at 801-847-7722 to discuss your specific needs and ensure that we can meet your expectations. ARL's on-time rating is greater than 97%, so there's a good chance that we can fulfill your needs, but we never want to over-commit and under-deliver.

While we have been known to “pull rabbits out of the hat,” ARL is technically closed on weekends. Technicians schedule their hours in order to ensure they meet all due dates, which may require weekend work on occasion. Our microbiology team is also required to conduct all transfers over the weekends, so we do have a small crew here.

Should you need special consideration for one of these days, please feel free to reach out to us. We will do all we can to accommodate your needs wherever possible.

Absolutely! ARL offers free local courier services at all of our locations around the country.

One of the best things you can do to help us help you is to provide sufficient sample for duplicate or even triplicate testing. Nothing slows down testing more than to have to request additional material from our partners. However, what that means is that we generally have lots of product left over for retention. These retention samples are stored at room temperature (unless otherwise indicated) for at least 60 days, after which they are discarded. Any controlled substances are treated as required by law prior to discarding.

You may request additional testing for a sample. Please call one of our Partnership or Sample Management team members at 801-847-7722 to discuss your specific needs. Depending on the analysis you are adding, this may extend your turnaround times. We will do all we can to move things along as quickly as possible.

Analytical Resource Laboratories offers thousands of analyses, each one requiring a different amount of material for testing. Your customized quote will detail the quantity needed for each analysis. However, a good rule of thumb is "the more the better." Nothing slows down testing more than to have to request additional material from our partners. The following is a very general rule. Please consult your customized quote for more specific information.

• Routine Micro - 50g
• Heavy Metals and other minerals - 10g
• Vitamins and other HPLC, GC testing - 10g
• FTIR - 10g
• HPTLC - 10g

Analytical Chemistry and Microbiology are as much an art form as they are a science. We wish the testing were as simple as putting in the sample and hitting a button, but unfortunately, it is not. Matrix interferences, unsuitable calibration curves, or incorrect specifications may necessitate repeat testing. On occasion, technical or analyst issues occur, which may also require follow-up testing and verification testing. In such instances, additional samples may be required. A good rule of thumb regarding the amount of material to submit to the lab for analysis is “the more the better.” Nothing slows down testing more than to have to request additional material from our partners.

Analytical Resource Laboratories LabTracker LIMS (Laboratory Information Management System) allows our partners to submit samples, view the in-process status of a sample, and view certificates of analysis online. Additionally, our FAQs page provides a wealth of information, and we have a team of individuals working on video tutorials that we feel will be great resources for our partners.

Retesting of samples may be necessary for several reasons. Most commonly, samples are retested because they are either Out of Specification (OOS), the wrong sample was submitted, or the wrong anaysis was requested. In these cases, the submitting party will be billed for the retest.

When errors occur on our end, whether it be analyst error, instrument error, or unsuitability of the method, we do not charge the submitting party for the retesting.

ARL is committed to “doing it right, on time, every time.” However, sometimes there are issues that arise that do not allow for on-time reporting. Here are the most common reasons:

• Wrong sample submitted

  Wrong Sample. On occasion, partners submit the wrong sample, and we are only able to identify this issue after we run the initial testing, and our Out-Of-Specification investigations (OOS) is conducted. We get it. We all make mistakes on occasion. No worries. We work the problem, and move forward.

• Unsuitable method for the sample matrix

  Unsuitable Matrix. Unfortunately, running analytical tests is not as simple as putting a product in a machine and pushing a button. (How we wish it were that simple.) Analytical chemistry is as much an art form as it is a true science. Filtering through complex matrices to find the analyte of interest takes real skill and experience. We make every effort to validate our methods across diverse products and matrices, but there is no such thing as a “one-size-fits-all” method. As a third-party contract lab, we literally see thousands of diverse and unique products every month. Each one is tested and scrutinized individually, one-by-one. Sometimes, these steps take longer than anticipated.

• Detection of suspect positive pathogens and analyses that are Out of Spec (OOS)

  Suspect positive pathogens. We learn in Microbiology 101 that microorganisms are living, breathing organisms that adapt to their environment and strive to survive. Interpretation of literally in-numerable species of organisms and identifying the pathogen of interest can be challenging, since many organisms may initially look very similar to one another. As our highly skilled microbiologists read and interpret results, proper protocol dictates additional steps to verify what they are seeing, and smelling (yuck!). These steps take time, even days, to complete. While we sincerely regret the delay in testing, our integrity and dedication to “doing it right” is our guiding force. Please know that if your results take longer than expected, it is only to protect YOU and mitigate YOUR risks.

  Note: In February 2021, we will be announcing some very exciting news and rolling out publications regarding rapid pathogens testing by PCR. This is a joint venture between ARL and BioMerieux. This technology will help us reduce micro turnaround times even further!

• Incorrect specifications, or specifications not provided

  Specifications not provided or incorrect. When testing products for a particular analyte, knowing your manufacturing specifications for that analyte is very important. Label claims are not specifications because they do not account for overages and degradation rates. So, please let us know what you are expecting so that we know where to go looking. Products need to be diluted and prepared for analysis and, if we are “shooting in the dark,” we may have to retest the sample multiple times or carry out an unnecessary OOS investigation, all of which are wastes of time. Accurate specifications will greatly reduce delays in testing.

• Quality controls and quality retesting error

  Random error is an expected and inevitable part of laboratory testing. Because ARL is committed to the quality of the results released to you, controls are always run alongside your samples to catch these potential sources of error. If a quality control fails to meet acceptance criteria, the entire affected batch will need to be rerun. Although this unfortunately may cause delays for you, it is necessary in order to provide high-quality results you can have confidence in.

ARL can currently test for the following unbound Amino Acids: Alanine, Arginine, Aspartic Acid, Cystine, Glutamic Acid, Glycine, Histidine, Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Proline, Serine, Threonine, Tyrosine, Valine.

Bound amino acids are incorporated into proteins or attached in some secondary form. unbound amino acids are not.

There are a few different technologies that can be employed to test for Amino Acids; UPLC, HPLC, and LCMS. Theoretically, each of these technologies should produce identical results, however, the detection limits will vary.

ARL has obtained ISO 17025:2017 accreditation in Cannabinoid testing. Our most common panel contains 5 major and 10 minor cannabinoids. For the full list, please contact our Partnerships team.

ARL has performed extensive development and validation steps to ensure that we can test a wide variety of products and matrices. There is a great chance we can test your product.

As a DEA-registered laboratory, any product containing > 0.3% THC will need to be reported to the DEA.

Fourier transform infrared spectroscopy, or FT-IR, works by measuring the interactions between infrared light and chemical bonds to create a “fingerprint” for specific compounds and products. Samples can be compared to a library of these “fingerprints” to evaluate the identity.

Our library is vast and ever-expanding, but it does not contain everything. Standards may be purchased upon request.

Please contact your ARL partner representative for more information.

ARL offers ten (10), five (5), and three (3) day TAT’s on FT-IR analysis. One (1) day, or even same-day is available through special request. Call your ARL representative for assistance.

While FTIR is a powerful tool, it is always best to utilize orthogonal testing methods to create a robust testing profile. ARL’s HPTLC analysis is a great option for identification of herbal and plant materials. Please contact your ARL representative for information on additional test methods.

Current Good Manufacturing Processes (CGMP) require that every ingredient be verifiable through either empirical analysis in the finished good, or through proper identification and testing of raw materials, with clear and concise Master Batching Records (MBRs) and traceability. However, if the ingredient is testable in the finished good state, by a valid method, it is best to test it than to rely on MBR’s. Contact your ARL representative for help evaluating your specific needs.

ARL works closely with the American Kratom Association to ensure that we are up to date on the latest regulation and trends in Kratom. A typical profile of testing for Kratom may include a Complete Micro Profile, Heavy Metals, and Kratom Alkaloids including Mitragynine, 7-Hydroxy-Mitragynine, Speciogynine, and Paynantheine.

ARL offers ten (10), five (5), and three (3) day TAT’s on Kratom test packages. One (1) day, or even same-day is available through special request. Call your ARL representative for assistance.

Interpretation of microbiological results can be confusing. We want coliforms and pathogens such as E. coli, Staphylococcus aureus, Salmonella, Listeria, Clostridium, etc., to be "Negative" or “Absent.” Period!

Total Plate Count and Yeast and mold should generally be "low," with results of < 10 CFU's/g (less than 10 colony-forming units per gram) or < 100 CFU's/g. A result of < 10 CFU's/g means that we did not see any colony growth after 10 g of product was diluted into 90mL of solution (1:10 dilution), and allowed to incubate on the appropriate agar medium. This result does not mean that the sample is Negative or Absent for Total Plate Count, just that the way the test is setup does not allow us to detect numbers lower than 10.

These terms mean that the product was diluted into a nutrient-rich growth solution, incubated, and given every opportunity for even one CFU to grow, and nothing grew.

It is important to remember that, in microbiology, we are working with living, breathing organisms that are susceptible to environmental conditions. When we consider colony-forming units (aka counts) from one sample to the next, it is common to see those numbers ebb and flow. It is essential to look at results on a log basis (factors of 10) rather than small variations in counts. For example, let's say that you submit three samples of “Product A,” lot 12345, and get a Total Plate count of 500 CFU’s (colony forming units), 1,300 CFU’s, and 800 CFU's in your three samples. In the microbiology world, these three numbers are statistically equivalent. But wait, you might say that 1,300 is three times greater than 500! Remember, these are living, breathing organisms and are susceptible to their environment during raw material batching, blending, packaging, storing, etc., and counts do ebb and flow. In the micro world, we look at data in terms of factors of 10.

If you get a result of < 10 CFU’s/g in one sample and 50,000 CFU’s/g in another, let’s chat. These results are greater than a factor of 10 apart and warrant investigation.

Probiotic products contain viable bacteria that are beneficial to the digestion system of humans and other animals. The setup and testing procedures for probiotics are very different than standard microbial testing methods. The dilution schemes are much higher; the agar medium contains a distinct nutritional profile different from the typical routine microbiological analysis. The incubation requirements are particular as well. Most probiotics need to be incubated anaerobically (little to no oxygen in the chamber). Some are obligate anaerobes, meaning that they cannot tolerate any oxygen while growing. Others are micro-aerophilic, meaning that they can grow in the presence of some oxygen but prefer little oxygen. Additionally, some probiotics need to be "activated" before testing.

It is important to note that most probiotics will die off at room temperature over time. For this reason, many probiotic products recommend that the consumer keep the product in the refrigerator to slow down this depletion. Heat accelerates this depletion much more rapidly.

With so many variables that factor into the final test result of a probiotic product, it stands to reason that some products with an extensive blend of species can be complicated. Consistency in your manufacturing, storage conditions of raw materials and finished products, raw material expiration dates, etc., all factor into the final test result.

We perform Mineral and Heavy Metals analysis by ICP-MS. The most significant 25 nutritional minerals include: Be, Na, Mg, Al, P, K, Ca, V, Cr, Mn, Fe, Ni, Cu, Zn, Ge, As, Se, Ag, Cd, Sb, Hg, Pb, B and Ba, however we can test many, many more.

There are three main technologies used to detect minerals: ICP-MS, and ICP-OES, and ICP-AA. Each technology uses a different detection system and has their own particular sensitivities and specialties. ARL uses ICP-MS for is extremely low detection limits and flexibility in testing methods.

Detection limits are specific to analyses, however the MDL precision and accuracy of our methods are best at 1 ppb (parts per billion) and higher.

The two most common reporting units for minerals and heavy metals are PPM (parts per million), and PPB (parts per billion). Some of our partners prefer to report in mcg/serving in order to demonstrate compliance to California’s Prop 65 regulations.

ARL’s Heavy Metals profile includes Arsenic (As), Cadmium (Cd), Lead (Pb) and Mercury (Hg), which are the standard four in the industry.

ARL recommends that our partners refer to California’s Prop 65 regulations to determine if their products meet the requirement. If you have questions, please give us a call and we may be able to point you in the right direction.

ARL offers ten (10), five (5), and three (3) day TAT’s on heavy metals and minerals testing. One (1) day, or even same-day is available through special request. Call your ARL representative for assistance.

The contents of a Nutrition Facts Panel are controlled by the FDA and are very specific about what needs to be listed. Supplement Facts Panels are far more flexible, and to a great degree are determined by the manufacturer or distributor of the finished good.

• Source of Protein and Fiber
• A full ingredient list

Yes, ARL can provide both insoluble and soluble fiber data.

ARL offers ten (10) and five (5) day turnaround times on Nutrition and Supplement Facts analyses?

ARL offers several packages, depending on the specific analytes required in your testing.

You must use the package that best fits your regulatory needs.

ARL offers several packages, depending on the specific analytes required in your testing. You must use the package that best fits your regulatory needs. Please contact us to discuss your particular needs.

Analytical Resource Labs tests for many Vitamins, however the product matrices can have an effect on which vitamins are detectable in the product. Unfortunately, there is no single method that will detect every vitamin. However, our methods encompass the most common forms of vitamins including:

• Vitamin A - Beta carotene, Retinyl palmitate, retinyl acetate
• Vitamin B - B1 (Thiamin HCl), B2 (riboflavin), B3 (Niacin, niacinamide), B5 (pantothenic acid), B6 (pyridoxine HCl), B9 (Folate)
• Vitamin C - Ascorbic acid (calculations for various salt forms as well, ex: calcium ascorbate)
• Vitamin D - Ergocalciferol (D2), Cholecalciferol (D3)
• Vitamin E - Tocopherol, tocopherol succinate, tocopherol acetate
• Vitamin K - K1