Merck: Secondary Standards for Pharmaceutical Quality Control

Certified Fluka^® Pharmaceutical Secondary Standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to pharmacopeia primary standards. Our secondary standards have multi-traceability to the USP, EP and BP primary standards; in addition, they are manufactured according to ISO/IEC 17025 and ISO Guide 34.

The FDA, USP and EP all recognize the use of secondary standards or working standards that are established with reference to the corresponding primary standard. See specifics for Regulatory Recognition of Secondary Standards.

Features & Benefits

The important product features are:

Traceability to United States Pharmacopeia (USP); also to European Pharmacopoeia (EP) and British Pharmacopoeia (BP), if available
Analysis performed on instruments validated according to GMP using pharmacopeia monograph methods
Certified value according to ISO Guide 34 and ISO 17025 using mass balance approach
Comprehensive certificate according to ISO Guide 31.

The main benefits are:

Eliminate time and effort involved with preparing and validating your own working standards
Price advantage relative to primary reference standards; also, when larger quantities are purchased.

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