Item no.
BAM-S053
Unit
2000 g
Shipment details
No Dangerous Good /not restricted
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Description
Hydrolytic resistance is especially important for the manufacture of glass pharmaceutical primary packaging, since most medicines are preserved in a watery solution. In the international Pharmacopoeias PhEur and USP (Ph Eur = Pharmacopoea Europaea and USP = United States Pharmacopeia) the glass types used in manufacturing are split into water-resistance class Type I (highest resistance) to Type III. ISO 719 and 720 and the international Pharmacopoeias PhEur and USP describe analytical methods for the determination of hydrolytic resistance (glass-grain test). The new certified reference material BAM-S053 replaces the CRM NIST SRM 623 which is no longer available. Certification was done in an international certification round robin in cooperation with the international commission on glass (ICG) and the working group lass analysis of the Deutsche Glastechnische Gesellschaft e.V. (DGG). In total 15 laboratories from industry and research participated in the certification interlaboratory comparison. Certified values are given for the hydrolytic resistance according to ISO 720, USP<660> and Ph.Eur /// An informative value for hydrolytic resistance according to ISO 719 is given /// CRM BAM-S053 is available in the form of glass rods (length: 185 mm, diameter: 9 mm, weight per rod: 27.5 g). It is supplied in boxes containing ca. 2 kg of material.
Contents
Miscellaneous
Certificate of Analysis (specimen)
Reference Material CoA specimen: for the current lot, please contact your customer service representative at info@labmix24.com
Product data sheet
View all available product details e.g. description, analytes/parameters, CAS Number, concentrations/values, sales unit/product format, method, source, transport information
The German Federal Institute for Materials Research and Testing (BAM) draws upon more than 100 years of tradition developing reference materials to support correct and reliable measurements.
These reference materials are useful for determining measurement uncertainty, calibration, validation of methods, and for suitability testing and quality assurance.
BAM is accredited by the Deutsche Akkreditierungsstelle (DAkkS) as a producer of reference materials (RM and CRM) in accordance with ISO 17034 (General requirements for the competence of reference material producers). The reference materials are certified in accordance with the principles and requirements of ISO 17034 and ISO Guide 35.