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`1 Reagent Lane
`Fair Lawn, NJ 07410
`201.796.7100 tel
`201.796.1329 fax
`
`Certificate of Analysis
`
`Fisher Scientific's Quality System has been found to conform to Quality Management System
`Standard ISO9001:2008 standard by SAI Global Certificate Number CERT - 0064970
`
`This is to certify that units of the lot number below were tested and found to comply with the specifications of the grade listed. Certain data have been
`supplied by third parties. Fisher Scientific expressly disclaims all warranties, expressed or implied, including the implied warranties of merchantability
`and fitness for a particular purpose. Certain products (USP/FCC/NF/EP/BP/JP grades) are sold for use in food, drug, or medical device manufacturing.
`Fisher does not claim regulatory coverage under 21 CFR nor maintain DMF's with the FDA. The following are the actual analytical results obtained:
`
`S671
`Catalog Number
`153257
`Lot Number
`SODIUM CHLORIDE, BIOLOGICAL GRADE, CERTIFIED
`Description
`Country of Origin
`United States
`* Suggested Retest Date
`Inorganic-non animal
`Chemical Origin
`
`Quality Test / Release Date 6/26/2015
`
`Jun-2020
`
`BSE/TSE Comment
`
`No animal products are used as starting raw material ingredients, or used in
`processing, including lubricants, processing aids, or any other material that might
`migrate to the finished product.
`
`Chemical Comment
`
`This material does not contain any BPA (Bisphenol A), phthalates/phthalate esters or
`animal derived substances.
`
`Result name
`APPEARANCE
`ASSAY
`BARIUM (Ba)
`BROMIDE
`CALCIUM
`CHLORATE & NITRATE
`HEAVY METALS (as Pb)
`IDENTIFICATION
`INSOLUBLE MATTER
`IODIDE
`IRON (Fe)
`MAGNESIUM
`PH AT 25 DEGREES C
`PHOSPHATE (PO4)
`POTASSIUM (K)
`SULFATE (SO4)
`
`Units
`
`%
`PASS/FAIL
`%
`%
`%
`ppm
`PASS/FAIL
`%
`%
`ppm
`%
`
`ppm
`%
`%
`
`Specifications
`REPORT
`>= 99.0
`= PASS TEST
`<= 0.01
`<= 0.002
`<= 0.003
`<= 5
`= PASS TEST
`<= 0.005
`<= 0.002
`<= 2
`<= 0.001
`Inclusive Between 5.0 - 9.0
`<= 5
`<= 0.005
`<= 0.004
`
`Test Value
`Small white crystals
`99.6
`PASS TEST
`<0.010
`<0.0010
`<0.0003
`<5.0
`PASS TEST
`0.0040
`<0.0020
`<2.0
`0.0002
`5.8
`<5.0
`0.0020
`<0.0040
`
` Lab Manager Fair Lawn
`
`Note: The data listed is valid for all package sizes of this lot of this product, expressed as a extension of this catalog number listed
`above. If there are any questions with this certificate, please call Chemical Services at (800) 227-6701.
`*Based on suggested storage condition.
`
`ALKERMES Exh. 2064
`Luye v. Alkermes
`IPR2016-1096
`
`
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