Analytical Reference Materials USP Class 1 Residual Solvent Mixture Catalog # 36279 Lot # A085001 110 Benner Circle Bellefonte, PA 16823-8812 (814) 353-1300 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
110 Benner Circle Bellefonte, PA 16823-8812 Tel: (800)356-1688 Fax: (814)353-1309 www.restek.com Certificate of Analysis FOR LABORATORY USE ONLY-READ MSDS PRIOR TO USE. Catalog No. : 36279 Lot No.: A085001 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 75-35-4 99% 40.0 mg/ml +/- 0.2326 mg/ml 2 1,1,1-trichloroethane 71-55-6 99% 50.0 mg/ml +/- 0.2907 mg/ml 3 carbon tetrachloride 56-23-5 99% 20.0 mg/ml +/- 0.1163 mg/ml 4 Benzene 71-43-2 99% 10.0 mg/ml +/- 0.0581 mg/ml 5 1,2-Dichloroethane 107-06-2 99% 25.0 mg/ml +/- 0.1453 mg/ml 4 Solvent: DMSO 67-68-5 99% Column: 60m x.53mm x 3.0um Rtx-1301 (cat.# 16088) Carrier Gas: helium-constant pressure 7 psi Temp. Program: 55 C (6') to 185 C @ 20 C/min. to 240 C @ 30 C/min.(5') Inj. Temp: 210 C Det. Temp: 250 C Det. Type: FID Page 2 of 5
Date Passed: 14-Nov-2011 Balance: 1121472889 1 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 80397 Page 3 of 5
Catalog #: 36279 Target: 10-50 mg/ml Description: USP Class 1 Residual Solvent Mixture Solvent: DMSO Solvent Lot: DE454 Chemical Standard Batch Sheet Lot #:A085001 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 #: 1121472889 Compound CAS 1,2-Dichloroethane 107-06-2 1,1,1-trichloroethane 71-55-6 carbon tetrachloride 56-23-5 1,1-dichloroethene 75-35-4 Benzene 71-43-2 Storage Target Location Lot # Purity Conc(mg/mL) Target Actual Calc Conc(mg/mL) F0005 30696PMV 0.99 25.00 12,500.00 mg 12,500.00 mg 25.0 F0012 SF-20080520 0.99 50.00 25,000.00 mg 25,000.00 mg 50.0 F0018 02241MB 0.99 20.00 10,000.00 mg 10,000.00 mg 20.0 F0031 06097EJV 0.99 40.00 20,000.00 mg 20,000.00 mg 40.0 R0584 42596BPV 0.99 10.00 5,000.00 mg 5,000.00 mg 10.0 Page 4 of 5
QA Report: USP Class 1 Residual Solvent Mixture (Cat.#36279) Runs of Lot # A085001 Runs of Lot # A083884 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 21271353 21732695 21751241 21585096 271868 1.26 22238118 22164985 22156223 22186442 44967 0.20-2.79 PASS 1,1,1-Trichloroethane 21823336 22232396 22253622 22103118 242531 1.10 22072310 21983171 22012139 22022540 45471 0.21 0.36 PASS Carbon tetrachloride 2771347 2823201 2827358 2807302 31207 1.11 2820595 2808488 2813249 2814111 6099 0.22-0.24 PASS Benzene 21156348 21519919 21530172 21402146 212929 0.99 21415326 21314197 21362189 21363904 50586 0.24 0.18 PASS 1,2-Dichloroethane 14626828 14841866 14853771 14774155 127728 0.86 14792639 14718258 14758254 14756384 37226 0.25 0.12 PASS Page 5 of 5 11/14/2011 1:12:16 PM 1/1-1