PHENACETIN MELTING POINT STANDARD CERTIFIED REFERENCE MATERIAL

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1 PHENACETIN MELTING POINT STANDARD CERTIFIED REFERENCE MATERIAL O O CH 3 H 3 C N H LOT #: BCBD3893V Fluka No NOMINAL WT: 1 g CORRESPONDS TO RTC LOT: P CERTIFICATE ISSUE DATE: 11. December 2012 VERSION: BCBD3893V-4 Note: Certificates may be updated due to Compendial Lot changes or the availability of new data. Check our website at: for the most current version. EXPIRATION: SEP / 2013 (Proper Storage and Handling Required) STORAGE: Store in a Refrigerator, keep container tightly closed. Attachment of a 20 mm aluminum crimp seal recommended for unused portions. CHEMICAL FORMULA: C 10 H 13 NO 2 MW: PHYSICAL DESCRIPTION: White powder in amber vial CAS #: HAZARDS: Read MSDS before using. Always handle as if potentially hazardous using prudent laboratory techniques. INSTRUCTIONS FOR USE: Dry over silica gel for 16 hours prior to use. The internal pressure of the container may be slightly different from the atmospheric pressure at the user s location. This material is intended for LABORATORY USE ONLY and NOT for use in humans or animals. Certificate of Analysis Version BCBD3893V-4 Page 1 of 5

2 CERTIFIED MELTING RANGE/POINT (dried basis) Specification: The observed range falls within the acceptance range: NMT 1.9 between and (USP). METHOD: All samples were dried 16 hours over silica gel. The melting range/melting point of the Phenacetin Melting Point Standard was determined concomitantly with the melting range/melting point of the USP Phenacetin Melting Point Standard using the capillary method. This method demonstrates direct traceability to the USP Reference Standard. Reference: USP <741> Instrument: Mettler Toledo FP900 Thermosystem with FP81 Measuring Cell Temperature Program: to C at 0.2 C/min MELTING RANGE Result U crm RTC LOT: P C ± 0.15 C, k = 2.06 USP LOT: J0J C ± 0.25 C, k = 2.10 MELTING POINT RTC LOT: P C ± 0.18 C, k = 2.18 USP LOT: J0J C ± 0.21 C, k = 2.2 Temperature Program: to C at 0.5 C/min MELTING RANGE Result U crm RTC LOT: P C ± 0.41 C, k = 2.18 USP LOT: J0J C ± 0.15 C, k = 2.08 MELTING POINT RTC LOT: P C ± 0.26 C, k = 2.2 USP LOT: J0J C ± 0.17 C, k = 2.20 Note: The U crm values for the USP Reference Standard do not contain a component of homogeneity, since this information is not available from the USP. Certificate of Analysis Version BCBD3893V-4 Page 2 of 5

3 LOSS ON DRYING/VOLATILES /VOLATILES Method: 60 C for 1 hour (ref.: USP Phenacetin RS) Mean of three samples, Loss = 0.03% IDENTIFICATION TESTS INFRARED SPECTROPHOTOMETRY (Comparative identification analysis demonstrates direct traceability to Pharmacopeial standards) 1 H NMR (Data provided by an external laboratory; not in scope of accreditation) Certificate of Analysis Version BCBD3893V-4 Page 3 of 5

4 ELEMENTAL ANALYSIS (Data provided by an external laboratory; not in scope of accreditation) Exeter Analytical 440 Elemental Analyzer Combustion method Results of duplicate analysis: % Theoretical Experimental Mean C H N HOMOGENEITY ASSESSMENT Between-bottle homogeneity was assessed in accordance with ISO Guide 35. Completed units were sampled over the course of the bottling operation. Samples were taken in the following manner: the units produced in the bottling operation were divided into three chronological groups, those from the Early third, the Middle third, and the Late third (Groups). A pre-determined number of sample units were then randomly selected from each group. A subset of each group was then randomly Certificate of Analysis Version BCBD3893V-4 Page 4 of 5

ANALYTICAL METHOD: MELTING POINT An analytical sample was prepared from each of four bottles from each Group

3 mg Replicate (triplicate) analysis was performed on each sample. The order of replicate analyses was randomized.

No significant difference between the Groups was indicated.

5 selected for chemical analysis. The results of the chemical analysis were then compared by Single Factor Analysis of Variance (ANOVA). ANALYTICAL METHOD: MELTING POINT An analytical sample was prepared from each of four bottles from each Group (Early, Middle, and Late/twelve total). Sample size: ~3.3 mg Replicate (triplicate) analysis was performed on each sample. The order of replicate analyses was randomized. The between bottle standard deviation was derived from the ANOVA. No significant difference between the Groups was indicated. Heterogeneity was not detected under the conditions of the ANOVA. Certified by Reviewed by Validity Date Quality Systems THIS PRODUCT WAS DESIGNED, PRODUCED AND VERIFIED BY RTC- USA FOR ACCURACY AND STABILITY IN ACCORDANCE WITH ISO 17025:2005 (ACLASS Cert AT-1467) and ISO GUIDE 34:2009 (ACLASS Cert AR-1470). Certificate of Analysis Version BCBD3893V-4 Page 5 of 5

ASPIRIN (ACETYLSALICYLIC ACID) CERTIFIED REFERENCE MATERIAL

ASPIRIN (ACETYLSALICYLIC ACID) CERTIFIED REFERENCE MATERIAL HO O O CH 3 O LOT #: BCBD0724V Fluka No. 01478 NOMINAL WT: 1 g CORRESPONDES TO RTC LOT: P500003 CERTIFICATE VALIDITY DATE: 20. October 2011 VERSION: