USP Class 1 Residual Solvent Mixture
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1 Analytical Reference Materials USP Class 1 Residual Solvent Mixture Catalog # Lot # A Benner Circle Bellefonte, PA (814) FOR LABORATORY USE ONLY. READ MSDS PRIOR TO USE. RAW MATERIAL TEST INFORMATION AVAILABLE UPON REQUEST MANUFACTURED UNDER RESTEK'S ISO 9001 REGISTERED QUALITY SYSTEM Page 1 of 5
2 110 Benner Circle Bellefonte, PA Tel: (800) Fax: (814) Certificate of Analysis FOR LABORATORY USE ONLY-READ MSDS PRIOR TO USE. Catalog No. : Lot No.: A Description : USP Class 1 Residual Solvent Mixture Residual Solvents - Class 1, 10-50µg/ml, DMSO, 1ml/ampule Container Size : 5 2 ml Pkg Amt: 5 > 1 ml Expiration Date : November 2014 Storage: 10 C or colder Elution Order Compound CAS # Percent Purity 2 Grav. Conc. (weight/volume) 3 Grav.Uncert. (95% C.L.; K=2) 1 1,1-dichloroethene % 40.0 mg/ml +/ mg/ml 2 1,1,1-trichloroethane % 50.0 mg/ml +/ mg/ml 3 carbon tetrachloride % 20.0 mg/ml +/ mg/ml 4 Benzene % 10.0 mg/ml +/ mg/ml 5 1,2-Dichloroethane % 25.0 mg/ml +/ mg/ml 4 Solvent: DMSO % Column: 60m x.53mm x 3.0um Rtx-1301 (cat.# 16088) Carrier Gas: helium-constant pressure 7 psi Temp. Program: 55 C (6') to C/min. to C/min.(5') Inj. Temp: 210 C Det. Temp: 250 C Det. Type: FID Page 2 of 5
3 Date Passed: 14-Nov-2011 Balance: Expiration date of the unopened ampule stored at the recommended storage condition is the last day of the month listed. 2A Purity and chemical identity are determined by one or more of the following techniques: GC/FID, HPLC, GC/ECD, GC/MS. Purity value is rounded to the nearest whole number. See data pack or contact Restek for further details. 2B Compounds with a listed purity of less than 99% have been weight corrected to compensate for impurities. 2C The following types of compounds will have a listed purity of less than 99%: Aldehyde/Ketone-DNPH compounds, Bromides, Chlorides, HCL salts, HBR salts, sulfates, hydrates, and other compounds as necessary. The listed purity is a correction factor that is equivalent to the percentage of parent compound in the molecule. This correction factor is used to calculate the amount of compound necessary to achieve the desired concentration of the parent compound in solution. The concentration listed on the certificate is the concentration of the parent compound in the solution. 2D Purity of isomeric compounds is reported as the sum of the isomers. Value is rounded to the nearest whole number after summation. 3 Based upon gravimetric preparation with balance calibration verified using NIST traceable weights (seven mass levels) and/or class A glassware used for dilutions. 4 Uncertainties determined using data for balances and glassware from measurement systems analysis methodology, raw material purity, and, when significant, equipment tolerances or calibration results. 5A Containers are overfilled to ensure the packaged amount, as a minimum. 5B Restek supplies deactivated vials along with most standards packed in 2 ml ampules, for the handling and storage of standards. Due to space constraints, Restek does not supply vials for larger volume ampules. Samples should be transferred into deactivated vials for handling and storage. Restek sells DMDCS for the purpose of glassware deactivation as catalog number 31840, which includes complete instructions. Restek will also deactivate larger volume vials from our inventory, as a custom ordered item. Contact your Restek sales or customer service representative for details. Manufactured under Restek's ISO 9001:2008 Registered Quality System Certificate #FM Page 3 of 5
4 Catalog #: Target: mg/ml Description: USP Class 1 Residual Solvent Mixture Solvent: DMSO Solvent Lot: DE454 Chemical Standard Batch Sheet Lot #:A Final Volume: 500 ml Made by: Joe Tallon Date: 11/7/2011 1:36:26PM Tested by: Diane Shaffer Pass Date: 11/10/2011 3:50:46PM By: Chris Zucco Date: 11/14/2011 1:50:29P Packaged by: Joe Conway / Joe Conway Date: 11/10/2011 2:56:01P No. Units: 312 Pkg Size: 1 ml Balance Used: ARMBALPC6 AX204 Serial #: Compound CAS 1,2-Dichloroethane ,1,1-trichloroethane carbon tetrachloride ,1-dichloroethene Benzene Storage Target Location Lot # Purity Conc(mg/mL) Target Actual Calc Conc(mg/mL) F PMV , mg 12, mg 25.0 F0012 SF , mg 25, mg 50.0 F MB , mg 10, mg 20.0 F EJV , mg 20, mg 40.0 R BPV , mg 5, mg 10.0 Page 4 of 5
5 QA Report: USP Class 1 Residual Solvent Mixture (Cat.#36279) Runs of Lot # A Runs of Lot # A COMPONENT Run #1 Run #2 Run #3 AVG STD DEV % RSD Run #1 Run #2 Run #3 AVG STD DEV % RSD %D MEAN P/F 1,1-Dichloroethene PASS 1,1,1-Trichloroethane PASS Carbon tetrachloride PASS Benzene PASS 1,2-Dichloroethane PASS Page 5 of 5 11/14/2011 1:12:16 PM 1/1-1
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