CERTIFIED REFERENCE MATERIALS STANDARDS · Global/ICH Elemental Impurities in Pharmaceuticals and...
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SPEX CertiPrep is the industry leader for over 50 years in the CRM marketplace meeting the needs of laboratories worldwide with innovation and research. INORGANIC CERTIFIED REFERENCE MATERIALS ICH/GLOBAL COMPLIANCE STANDARDS In the pharmaceutical industry, the guidelines set by the United States Pharmacopeia (USP) and the International Conference on Harmonization (ICH) have pushed the pharmaceutical and nutraceutical industries to provide accurate, quantifiable results for the metal analysis in drugs, pharmaceutical substances and raw materials. The International Conference for Harmonization (ICH) has produced a concept paper proposing a new guideline intended to provide a global policy for qualitatively and quantitatively limiting metal impurities in drug ingredients and finished products. The new proposed guideline (Q3D) would provide clarification of the requirements for metals, which are included in the ICH inorganic impurities classification. In the US, the FDA has pushed the pharmaceutical and nutraceutical industries to provide accurately quantifiable results. The current USP Heavy Metals procedure USP <231> is being replaced by the final proposed chapters for setting specifications (USP <232>) and methodology (USP <233>) for the metal analysis in drugs, pharmaceutical substances and raw materials. SPEX CertiPrep is proud to offer a line of analytical standards for the analysis of trace metals in pharmaceutical materials. These standards can be used as a calibration or check standard to verify all component or dosage limits. Our experience in creating quality trace metal standards coupled with your ICP/MS analysis will ensure your company will remain compliant with the new and changing regulations. n UL and A2LA Stamp of Approval - Our Quality System is Certified by UL-DQS to ISO 9001:2008 - Accredited by A2LA for ISO 17025:2005 and ISO Guide 34-2009 n Inorganic CRMs for: - AA (Atomic Absorption) - GFAA (Graphite Furnace Atomic Absorption) - ICP (Inductively Coupled Plasma) [ICP-AES, ICP-OES] - ICP-MS (Inductively Coupled Plasma - Mass Spectroscopy) - IC (Ion Chromatography) - XRF (X-Ray Fluorescence) - Classical Wet Chemistry Techniques - All analytical techniques which require precise analytical reference materials are required n Features of SPEX CertiPrep Inorganic Reference Materials: - Single element standards are offered in 1,000 mg/L and 10,000 mg/L concentrations - Custom standards can be prepared at almost any concentration to your exact specifications - Standards packaged in a variety of convenient sizes, including 125mL, 250mL, and 500mL bottles - Wide selection of stock multi-component standards available; visit our web site for further details. - Accuracy and stability of components are guaranteed - Custom packaging available for your specific needs - Custom packaging readily available. - Custom blends manufactured upon request based on your individual needs. n Value of SPEX CertiPrep Inorganic Reference Materials: - All standards and starting materials are triple checked for quality - All standards are directly traceable to NIST SRMs, where available - Trace impurities are quantified by ICP-MS to ppb levels and reported in our SPEXertificate - Uncertainty of measured value is reported on the SPEXertificate - Weights used are traceable to NIST Inorganic & Organic Certified Reference Materials
Transcript of CERTIFIED REFERENCE MATERIALS STANDARDS · Global/ICH Elemental Impurities in Pharmaceuticals and...
SPEX CertiPrep is the
industry leader for
over 50 years in
the CRM marketplace
meeting the needs of
laboratories worldwide
with innovation
and research.
INORGANIC
C E R T I F I E D R E F E R E N C E M A T E R I A L S
ICH/GLOBAL COMPLIANCE STANDARDS
In the pharmaceutical industry, the guidelines set by the United States Pharmacopeia (USP) and the International Conference on Harmonization (ICH) have pushed the pharmaceutical and nutraceutical industries to provide accurate, quantifiable results for the metal analysis in drugs, pharmaceutical substances and raw materials. The International Conference for Harmonization (ICH) has produced a concept paper proposing a new guideline intended to provide a global policy for qualitatively and quantitatively limiting metal impurities in drug ingredients and finished products. The new proposed guideline (Q3D) would provide clarification of the requirements for metals, which are included in the ICH inorganic impurities classification. In the US, the FDA has pushed the pharmaceutical and nutraceutical industries to provide accurately quantifiable results. The current USP Heavy Metals procedure USP <231> is being replaced by the final proposed chapters for setting specifications (USP <232>) and methodology (USP <233>) for the metal analysis in drugs, pharmaceutical substances and raw materials.
SPEX CertiPrep is proud to offer a line of analytical standards for the analysis of trace metals in pharmaceutical materials. These standards can be used as a calibration or check standard to verify all component or dosage limits. Our experience in creating quality trace metal standards coupled with your ICP/MS analysis will ensure your company will remain compliant with the new and changing regulations.
n UL and A2LA Stamp of Approval - Our Quality System is Certified by
UL-DQS to ISO 9001:2008 - Accredited by A2LA for ISO 17025:2005
and ISO Guide 34-2009
n Inorganic CRMs for: - AA (Atomic Absorption)
- GFAA (Graphite Furnace Atomic Absorption)
- ICP (Inductively Coupled Plasma) [ICP-AES, ICP-OES]
- ICP-MS (Inductively Coupled Plasma - Mass Spectroscopy)
- IC (Ion Chromatography)
- XRF (X-Ray Fluorescence)
- Classical Wet Chemistry Techniques
- All analytical techniques which require precise analytical reference materials are required
n Features of SPEX CertiPrep Inorganic Reference Materials: - Single element standards are offered in
1,000 mg/L and 10,000 mg/L concentrations - Custom standards can be prepared at almost
any concentration to your exact specifications
- Standards packaged in a variety of convenient sizes, including 125mL, 250mL, and 500mL bottles
- Wide selection of stock multi-component standards available; visit our web site for further details.
- Accuracy and stability of components are guaranteed
- Custom packaging available for your specific needs
- Custom packaging readily available.
- Custom blends manufactured upon request based on your individual needs.
n Value of SPEX CertiPrep Inorganic Reference Materials: - All standards and starting materials are triple checked for quality - All standards are directly traceable to NIST
SRMs, where available
- Trace impurities are quantified by ICP-MS to ppb levels and reported in our SPEXertificate
- Uncertainty of measured value is reported on the SPEXertificate
- Weights used are traceable to NIST
Inorganic & Organic Certified Reference Materials
Glo
bal/I
CH E
lem
enta
l Impu
ritie
s in
Phar
mac
eutic
als a
nd D
ieta
ry S
uppl
emen
ts
Global/ICH Oral Elemental Impurities A
Cadmium 25 mg/kg
Mercury 15 mg/kg
Lead 5 mg/kg
Arsenic 1.5 mg/kg
ICH-TXM2 (125 mL)
Global/ICH Parenteral Elemental Impurities D (Big 4)
Lead 5 mg/kg
Cadmium 2.5 mg/kg
Arsenic 1.5 mg/kg
Mercury 1.5 mg/kg
ICH-TXM6 (125 mL)
Global/ICH Precious Metal Impurities B (with Os)
Iridium 100 mg/kg
Osmium 100 mg/kg
Palladium 100 mg/kg
Platinum 100 mg/kg
Rhodium 100 mg/kg
Ruthenium 100 mg/kg
ICH-TXM3 (125 mL)
Global/ICH Elemental Impurities E
Manganese 2500 mg/kg
Copper 1000 mg/kg
Chromium 250 mg/kg
Nickel 250 mg/kg
Cobalt 100 mg/kg
Molybdenum 100 mg/kg
Vanadium 100 mg/kg
ICH-TXM7 (125 mL)
Global/ICH Precious Metals Impurities B (without Os)
Iridium 100 mg/kg
Palladium 100 mg/kg
Platinum 100 mg/kg
Rhodium 100 mg/kg
Ruthenium 100 mg/kg
ICH-TXM4 (125 mL)
Global/ICH Elemental Impurities F
Iron 13000 mg/kg
Zinc 13000 mg/kg
ICH-TXM8 (125 mL)
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