Tools for Easier Compliance
The regulations for ultraviolet and visible spectroscopy were recently updated by the US and European pharmacopoeias. The revised US Pharmacopeia (USP) Chapter became mandatory on 1st December 2019. European Pharmacopoeia 10.0 (EP) Chapter 2.2.25 became mandatory on 1st January 2020.
Both standards now require absorbance linearity to be qualified and that qualification measurements are made at parameter values that match or ‘bracket’ those used for analysis. This may well mean that a single reference for e.g. stray light will no longer suffice and explains why potassium chloride solution, for example, is no longer a universal stray light reference but is recommended for the far UV. It also means that it is no longer possible to specify universal ‘kits’ that can qualify instruments for all applications.
The Basic Qualification Kits described below, however, will meet the routine needs of many laboratories and can be supplemented with additional references if required. Starna CRM kits offer cost savings when compared to the purchase of individual references.
Basic Qualification Kits
The kits below will allow instrument qualification over the stated wavelength and absorbance ranges for compliance with EP 2.2.25 and USP . References are provided to qualify wavelength accuracy, absorbance accuracy and 3-point linearity, stray light and resolution/bandwidth.
The stray light references for USP compliance are for Chapter Method B. Note that Potassium Chloride solution is included in all the basic kits as even if the instrument is not being used in the far UV, increasing stray light at this wavelength (200nm) is a sensitive indication of deterioration of the instrument optics.
These kits have been designed to qualify UV-visible spectrophotometers over the wavelength and absorbance ranges commonly used in pharmaceutical analysis. If your operating parameters fall outside these ranges, Starna has the world’s biggest range of spectroscopy CRMs and will be pleased to recommend additional or alternative references to meet individual requirements. For more information see Selecting References for Compliance - a User Guide or contact sales@starna.com for advice.
Basic Kit for EP 2.2.25 compliance
Catalogue number: RM-EP20
[Kit identity: RM-020610HLKCSIKISNTX]
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Reference |
To qualify |
Wavelength range |
|
Holmium cell |
Wavelength accuracy |
240 - 650 nm |
|
Potassium dichromate 20, 60 & 100 mg/l & blank cell. |
Absorbance accuracy and linearity, 0-1 A
|
235 – 350 nm |
|
Potassium chloride |
Stray light, 200nm |
200 -370 nm |
|
Sodium iodide |
Stray light, 220 nm |
|
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Potassium iodide |
Stray light, 250 nm |
|
|
Sodium nitrite |
Stray light, 340, 370 nm |
|
|
Toluene in hexane |
Resolution (bandwidth), 265-270nm |
265-270 nm |
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Basic kit for USP Chapter <857 compliance Catalogue number RM-USP20 [Kit identity RM-02061060HLKCKIACSNTX] |
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Reference |
To qualify |
Wavelength range |
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Holmium cell |
Wavelength accuracy |
|
|
Potassium Dichromate |
Absorbance accuracy and linearity, 0-1 A |
235 – 350 nm |
|
Potassium dichromate |
Absorbance accuracy, 1 A |
430 nm |
|
Potassium chloride |
Stray Light, 200 nm |
240 - 370 nm |
|
Potassium iodide |
Stray light, 220 nm |
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Acetone |
Stray light, 300 nm |
|
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Sodium nitrite |
Stray light, 340 nm |
|
|
Toluene in hexane |
Resolution (bandwidth), 265-270nm |
265-270 nm |
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Basic Combination kit for USP and EP compliance |
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|
Reference |
To qualify |
Wavelength range |
|
Holmium cell |
Wavelength accuracy |
240 - 650 nm |
|
Potassium Dichromate 20, 60 & 100 mg/l & blank cell. |
Absorbance accuracy and linearity, 0-1 A
|
235 – 350 nm |
|
Potassium dichromate |
Absorbance accuracy, 1 A (USP) |
430 nm |
|
Potassium chloride |
Stray light, 200 nm (EP &USP) |
200 -370 nm |
|
Sodium Iodide |
Stray light, 220 nm (EP) |
|
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Potassium Iodide |
Stray light, 220 nm (USP), 250nm (EP) |
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Acetone |
Stray light, 300 nm (USP) |
|
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Sodium Nitrite |
Stray light, 340 nm (EP & USP), 370 nm (EP) |
|
|
Toluene in Hexane |
Resolution (bandwidth), 265-270nm |
265-270 nm |
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Far UV extension kit - EP and USP compliance |
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|
Reference |
To qualify |
Wavelength range |
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Cerium cell |
Wavelength accuracy |
200 -270 nm |
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Nicotinic acid 6, 12 & 24 mg/l |
Absorbance accuracy and linearity, 0-1 A |
210 - 270 nm |
|
Visible Absorbance and Wavelength kit |
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|
Reference |
To qualify |
Wavelength range |
|
Holmium Filter |
Wavelength accuracy |
240 – 640 nm |
|
Neutral Density Filters, 0.25, 0.50 & 1.00A |
Absorbance Accuracy and Linearity |
440 – 635 nm |