Certificate of Analysis for Phage Complete

Below are the links to the Certificate of Analysis for each lot of Phage Complete.  Each lot is guaranteed to be meet all FDA GMP  specifications at time of manufacture. All ingredients used in manufacturing have also been tested by their manufacturer and meet all FDA GMP requirements. Independent inspections are also performed by NSF International.  The lab testing Phage Complete is also ISO/IEC 17025 and ISO 9001 accredited.

• Test Parameter – What was being tested
• Specification – The optimal level, or range.  Total CFU (colony-forming unit) is how much of the probiotic bacteria is in the capsule. The specification can either mean the “Analysis” number should be lower or higher than this number (annotated by less than and greater than signs).
• Analysis – This is how this batch actually tested.
• Method – There are standardized test protocols and specifications for each test run; this shows what specification was used.
• “* Store in an unopened container away from light and moisture at 4-8°C” – refers to how the product should be stored after testing but before their customer (The Gut Health Protocol, LLC) takes possession. This way the number of CFUs (and other parameters) will be the same as indicated in the COA when Phage Complete leaves their possession (note that the asterisk points to the release date). From there the product is shipped to us by refrigerated truck (usually “chilled” to 33-35°F and monitored) and stored under cool dry conditions.
• Total CFU Count Analysis – this number needs to be over 9 billion CFU’s in order for us to guarantee full strength for 18 months.

Phage Complete is guaranteed to have a minimum of the bottle listed 9 Billion CFU’s for 18 months from date of mfg when stored under shelf stable conditions. If your home gets hot in the summer, or you wish to extend the shelf-life even more, you should refrigerate the unopened bottle in a small zip locking bag along with a 1/4 cup of uncooked rice or a humidity control pack.  (also see shipping temperature information)

Certificate of Analysis
Date of Mfg	Lot #	File
10/30/2023 8/17/2022 10/21/2021 2/10/2021 5/12/2020	156514 152931 149445 146449 143175	2023-11-COA-for-DLE00012.pdf 2022-08-23 Phage Complete COA.pdf 2021-10-21 Phage Complete COA.pdf 2021-02-15 COA – Phage Complete.pdf 2020-05-12-Phage-Complete-COA.pdf

 

 

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

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