OptiMelt Automated Melting Point System - Stanford Research ...

More documents

Recommendations

Info

86 Melting Point Certified Reference Standards Appendix Bit is best to obtain CRSs directly from the US Pharmacopeia Convention in order todetermine the usability of the OptiMelt according to US Pharmacopeia protocols.• Beware of Standards Laboratories offering CRSs compatible with multiplepharmacopeias. Ask for samples of Certificates of Measurement before orderingstandards to assure the compatibility of their records with the pharmacopeia protocolyou plan to follow. Contact the Laboratory director whenever in doubt. A reputableaccreditation center will always be very helpful and forthcoming.• Occasionally, accreditation centers will run out of stock of some CRSs. In that rareevent, the standards lab should be able to recommend alternative sources for CRSswhile they restock their supplies. It is always a good idea to have an emergencysecond source of standards identified in case a backup supplier is required.• Some CRSs have expiration dates. Following strict GLP and GMP guidelines, QAlabs must keep track of those dates, and never use expired CRSs for calibration ordetermination of acceptability of their melting point equipment.• A slight drift in melting point results is expected when the melting point temperaturesobtained with a liquid bath oven are compared to those obtained with a metal blockoven under the same ramping conditions. This difference is to be expected andgenerally ignored since it generally falls within the intrinsic uncertainty of themeasurement.• Use capillary tubes of the same kind, and from the same supplier, to performcalibrations and to carry out all subsequent measurements. Beware that somepharmacopeia protocols include specific capillary requirements.• Failure to clean the tubing before making capillary melting tubes is one of the mostcommon causes of low melting points and broad melting point ranges. Wheneverpossible buy pre-made tubes from reputable sources, to assure the bestreproducibility of results.• Dry CRS samples carefully and store them in a vacuum dessicator between meltingpoint determinations. Forty eight hours over P 2 O 5 is a very common recommendationfor drying standards. Follow all standard-specific recommendations.Accreditation CentersThe following table is a list of accreditation centers which stock melting point CRSs.Notice that the scope of the centers ranges from local to worldwide.Keep in mind that certification protocols are constantly being revised and modified. Usethis table as reference only and access the Internet to update the records on this table ifnecessary.OptiMelt Automated Melting Point System
Appendix B Melting Point Certified Reference Standards 87Name Address/Phone E-Mail / WebWHO CollaboratingCenter for ChemicalReferenceSubstances(International)U.S. PharmacopeialConvention, Inc.(United States)LGC PromoChem(US, UK, Europe andWHO standards)National PhysicalLaboratory(United Kingdom)European Directoratefor the Quality ofMedicines(Europe)FrenchPharmacopeiaReferenceSubstances(France)Apoteket ABProduktion &LaboratorierCentrallaboratoriet, ACLPrismavägen 2, S-141 75Kungens KurvaSwedenTelephone:(+ 46-8)466-1000Fax: (+46-8) 740-6040Reference Standards OrderDepartment.12601 Twinbrook ParkwayRockville, MD 20852USATelephone:US and Canada: (800) 227-8772International : (+1-301) 881-0666Fax: (+1-301) 816-8148LGC PromochemQueens RdTEDDINGTONMiddlesexTW11 0LYUnited KingdomTelephone: +44 (0)20 8943 7000Fax : +44 (0)20 8943 2767Teddington TW11 0LWUKEuropean Pharmacopeia Council ofEuropeB.P. 907, F-67029Strasbourg Cedex 1France.Telephone: (+33-(0)3) 88 41 20 35Fax: (+33-(0)3) 88 41 27 71Agence Française de SécuritéSanitaire des Produits de SantéDirection des Laboratoires et desContrôlesSite de Montpellier-Vendargues635 rue de la GarenneF-34740 VendarguesFranceTelephone: (+33-(0)4) 67 91 39 00Fax: (+33-(0)4) 57 87 39 83E-mail:who.apl@apoteket.seWeb:www.usp.orgWeb:www.lgcpromochem.comE-mail:uk@lgcpromochem.comWeb:www.npl.co.uk.E-mail:CRS@pheur.orgWeb:www.pheur.orgOptiMelt Automated Melting Point System
Page 4 and 5:
iiSafety and Preparation For Use•
Page 6 and 7:
ivSafety and Preparation For UseOpt
Page 8 and 9:
viContentsMelting Point Range 57Mel
Page 10 and 11:
viiiFront Panel OverviewReady LEDA
Page 12 and 13:
xBack Panel OverviewPrinterOptiMelt
Page 14 and 15:
xiiSpecificationsOptiMelt Automated
Page 16 and 17:
2 Getting Started Chapter 1• Repl
Page 18 and 19:
4 Getting Started Chapter 1Ceramic
Page 20 and 21:
6 Getting Started Chapter 1Principl
Page 22 and 23:
8 Getting Started Chapter 1Quick St
Page 24 and 25:
10 Getting Started Chapter 18. Preh
Page 26 and 27:
12 Getting Started Chapter 1Touch t
Page 28 and 29:
14 Getting Started Chapter 1If none
Page 30 and 31:
16 Getting Started Chapter 1• Tou
Page 32 and 33:
18 Getting Started Chapter 1OptiMel
Page 34 and 35:
20 Displays and Menus Chapter 2Nume
Page 36:
22 Melt Screen Chapter 2Melt Screen
Page 39 and 40:
Chapter 2 Melt Screen 25Touch the T
Page 41 and 42:
Chapter 2 Melt Screen 27Select Newe
Page 43 and 44:
Chapter 2 Melt Screen 29Select Came
Page 45 and 46:
Chapter 2 Melt Screen 31Options Men
Page 47 and 48:
Chapter 2 Melt Screen 33The thermod
Page 49 and 50: Chapter 2 Timer Screen 35ResetTouch
Page 51 and 52: Chapter 2 T Meter Screen 37Alarm Lo
Page 53 and 54: Chapter 2 System Screen 39System Sc
Page 55 and 56: Chapter 2 System Screen 41The Print
Page 57 and 58: Chapter 2 System Screen 43Screen Me
Page 59 and 60: Melting Point Determination 45Chapt
Page 61 and 62: Chapter 3 Melting Point Determinati
Page 77 and 78: Maintenance and Calibration 63Chapt
Page 79 and 80: Chapter 4 Maintenance and Calibrati
Page 91 and 92: Pharmacopeia vs. Thermodynamic Melt
Page 93 and 94: Appendix A Pharmacopeia vs. Thermod
Page 99: Melting Point Certified Reference S
Page 103 and 104: Appendix B Melting Point Certified
Page 105 and 106: Using Melt Graphs 91Appendix CUsing
Page 107 and 108: Appendix C Using Melt Graphs 93The
Page 109 and 110: OptiMelt Remote Programming 95Appen
Page 111 and 112: Appendix D OptiMelt Remote Programm
Page 123: Appendix D OptiMelt Remote Programm
show all

OptiMelt Automated Melting Point System - Stanford Research ...

Create successful ePaper yourself

Delete template?

Save as template?