Showing posts with label USP. Show all posts
Showing posts with label USP. Show all posts

Monday, August 15, 2016

Don’t have a lot of time to wait for test results…read this!

Being organized and having a plan will help keep things moving quickly. One idea for improving the quality control process is to review all incoming raw materials and determine what testing can be completed before the blending process. Heavy metals, residual solvents, pesticides, identification, potency or assay, microbiology and other testing can be completed on the raw material. For example; heavy metal levels should not be affected by the manufacturing process, so screening the raw materials should provide accurate results when the product is released. This can be a huge time saver in the long-run.
If so much testing can be done at the beginning of the process, then what are we waiting on? Often, microbiology testing is the last step to complete before the product can be shipped. And since microbiological contamination is common in the manufacturing process, microbiology screening needs to be completed on the raw materials and again on the finished product before it is shipped. Technology and science have come a long way and this has given us rapid micro test methods, which can be completed within 48 hours.  Although these tests are not appropriate for every product matrix, they can be used with many products. This rapid testing saves time and can potentially save money.
Potency and label claim testing are also required for finished products. These tests are often complicated in the supplement matrix. Since USP/FCC methods are usually designed for the raw material matrix, once these ingredients are blended together, interferences may be found where recovery may be difficult. Testing is the only way to determine what potency markers are possible to measure. Once you know your product, you can tailor the appropriate finished product testing for the final release specifications.

Getting organized; testing your raw materials; and having a plan for finished product release testing, will go a long way in shipping your products faster. Additionally, using an ISO 17025 accredited testing lab that is proficient in the methods you require will also reduce the delays. And in those rare instances when everything seems to go wrong, SORA Labs can RUSH the testing you need to get you out of a bind!

Friday, April 15, 2016

Arsenic, Cadmium, Lead, and Mercury…Why Should You Care?

Heavy metals—What are they and why should you be concerned about them? The elements known as heavy metals include arsenic, cadmium, lead and mercury. These elements can be present in the soil that your materials are grown in or found in facilities where your products are produced. These contaminates can pose a health risk to your consumers and could even cause poisoning if they are consumed in high enough quantities. Due to their high health risk, the FDA requires testing for these analytes to be compliant with their GMP regulations. You may be asking yourself some questions regarding this testing and SORA Labs is here to answer them! Some of the most commonly asked questions and their responses are below:

Q: What stage of manufacturing can you test for heavy metals?
o   Raw Material
§  When you test your raw materials, you are more likely to catch a “bad” ingredient before you add it to your blend and ruin your entire batch. 
o   Finished Products:
§  Finished product testing confirms that the product meets required standards once all ingredients are blended and no heavy metal contamination occurred during the manufacturing process.

Q: Why Choose the ICP-MS method?
§  There are other methods that can be utilized for heavy metals analysis, however, ICP-MS allows the laboratory to achieve lower detection limits when compared to ICP-OES. This lowered detection limit allows for more accurate and precise data on your product.
§  Prop 65 requires certain limits of heavy metals to be met. Some prop 65 results can be obtained by ICP-OES; however, the serving size becomes a large factor. By using ICP-MS the factor of serving sizes becomes less of a deterrent. We are now able to achieve prop 65 levels on a larger variety of serving sizes.

If you have any remaining questions, please do not hesitate to contact us. SORA Labs would love to assist you with making sure your consumers are getting a top quality product! We offer ICP-MS heavy metal and mineral testing along with many other assays, ID and contaminate testing needed in the dietary supplement industry.  Visit our website today!



Thursday, January 16, 2014

Papain and Bromelain Enzyme Activity Testing

Papain and bromelain enzyme activity testing can be done here at SORA Labs.  This is one of the many enzyme assays that we preform.  We want to partner with your company on all your testing needs.

For papain and bromelain, we use the FCC PU method to determine the enzyme activity.  In some cases, bromelain is quoted in GDU activity.  GDU is not a compendial assay and has many variations of this method.  We perform the FCC PU assay, which is compendial, and then convert back to GDU.  I can send you our white paper explanation for the conversion if you let me know that you would want a copy.

FCC PU Activity Assay Description:
Hydrolysis of casein @ pH 6.0 (UV-Vis spectroscopy)

We offer many other enzyme assays from the USP or FCC Compendium. We are the only ISO lab with enzyme assays on our scope of accreditation in the US.  Please go to our website to view the complete list or email me for more testing capabilities.