Natural Products Insider

SEP-OCT 2017

INSIDER is the leading information source for marketers, manufacturers and formulators of dietary supplements, healthy foods and cosmeceuticals. Since 1997, INSIDER has been serving the needs of the global nutrition industry.

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naturalproductsinsider . com 59 third-party lab and the additional costs of using one can often put the contract manufacturer at a competitive cost disadvantage. For instance, the cGMP required testing for raw material identity, potency testing and contaminants can easily run from US$0.25 to as much as $1 per bottle of supplement. The more ingredients in the formula, the more testing required. Also, the order quantity impacts the testing cost per bottle—$2,000 in testing costs spread over a 2,000-bottle order impacts the cost per unit much greater than it does on a 10,000-bottle order. To help offset this cost, many contract manufacturers have worked to minimize the amount of testing required on incoming raw materials by qualifying their vendors. With suffi cient procedures, this allows the contract manufacturer to test the incoming raw materials on a "skip lot" basis and not test every lot. There are pros and cons to skip lot testing (which we won't get into here), but it's an avenue most contract manufacturers will explore as time goes on. A basic lab needs to have a means to test the identity and potency of the incoming raw material, as well as the active or biomarker compounds in fi nished products. The lab should be able to test for known adulterants outside of the normal heavy metal and microbiological contaminants. Identity testing: A contract manufacturer's lab should have means to test for raw material identity. This can be done by organoleptic methods: FTIR (Fourier transform infrared spectroscopy), FTNIR (Fourier transform near infrared spectroscopy), HPTLC (high-performance thin layer chromatography), and/or HPLC (high-performance liquid chromatography) and/or UPLC (ultra-performance liquid chromatography). Certain raw materials may require a mass spectrometer to test the material, but if this is required, the contract manufacturer will probably outsource the testing. Mass specs are expensive to buy ($200,000 to $500,000) and to operate. Regardless of the identity technique used, the key to this process is the reference standards. The fi rst lot of material received from a vendor is not a reference standard unless the vendor can show proof the material lot sent to the contract manufacturer was fully characterized. Using the fi rst lot of material as a standard, if it's not fully characterized, is a weak foundation for any lab. If the material is wrong or mischaracterized, all future lots will be fl awed, as well. A strong contract manufacturer's in-house lab is one that has invested in a library of reference standards. Organoleptic identity testing works if there is a trained person on staff, and the raw material lends itself to this type of testing. However, it may not be the best approach to identifying adulterants. Historically, FTIR is a fast, inexpensive way to compare two materials. The problem is sensitivity. FTIR is not sensitive enough to pick up some of the materials used in economically motivated adulteration. Be cautious about any lab using FTIR as the sole means of testing identity. A good contract manufacturer lab will use FTNIR, HPTLC and/or HPLC/UPLC to do the identity testing. Again, having reference standards is the key to detecting the presence to the correct material. FTNIR is fast and can detect adulterants, but can give some false negative results. HPTLC and HPLC/UPLC are the best for identifying raw materials, but the testing can be time consuming. If the contract manufacturer relies on HPTLC or HPLC/UPLC for testing, make sure it has adequate equipment and staff to handle the volume of samples. HPTLC can take a day to run test a sample. HPLC can take one to three hours to run one sample. UPLC is signifi cantly faster and can run a sample in 30 minutes or less. If the contract manufacturer receives/uses 200 different ingredients and makes 20 fi nished products a day, that amounts to a lot Contract Manufacturing: Ingredient Sourcing manufacturing CUSTOM CONTRACT solutions 2802 Dow Ave Tustin, CA 92780 714-832-9700 cGMP Compliant Visit us at SupplySide West September 27 & 28 Booth U121 Mandalay Bay Convention Center Las Vegas, USA powders capsules tablets DIETARY & FOOD SUPPLEMENTS SPORTS NUTRITION A strong contract manufacturer's in-house lab is one that has invested in a library of reference standards.

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