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]

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
Potassium iodide	Stray light, 250 nm
Sodium nitrite	Stray light, 340, 370 nm
Toluene in hexane	Resolution (bandwidth), 265-270nm	265-270 nm

Basic kit for USP Chapter <857 compliance Catalogue number RM-USP20 [Kit identity RM-02061060HLKCKIACSNTX]
Reference	To qualify	Wavelength range
Holmium cell	Wavelength accuracy
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	430 nm
Potassium chloride	Stray Light, 200 nm	240 - 370 nm
Potassium iodide	Stray light, 220 nm
Acetone	Stray light, 300 nm
Sodium nitrite	Stray light, 340 nm
Toluene in hexane	Resolution (bandwidth), 265-270nm	265-270 nm

Basic Combination kit for USP and EP compliance Catalogue number RM-USPEP20 [Kit identity RM-02061060HLKCSIKIACSNTX]
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)
Potassium Iodide	Stray light, 220 nm (USP), 250nm (EP)
Acetone	Stray light, 300 nm (USP)
Sodium Nitrite	Stray light, 340 nm (EP & USP), 370 nm (EP)
Toluene in Hexane	Resolution (bandwidth), 265-270nm	265-270 nm

Far UV extension kit - EP and USP compliance Catalogue number: RM-06A12A24ARE
Reference	To qualify	Wavelength range
Cerium cell	Wavelength accuracy	200 -270 nm
Nicotinic acid 6, 12 & 24 mg/l	Absorbance accuracy and linearity, 0-1 A	210 - 270 nm

Visible Absorbance and Wavelength kit Catalogue number RM-1N3N5DHG
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

Tools for Easier Compliance
UV Qualification Set	Part number: RM-USP	PRODUCT ENQUIRY
This set contains Starna Certified Reference Materials to qualify a UV spectrophotometer to USP Chapter <857>
Potassium Dichromate 60 mg/l & blank cell	Photometric Accuracy, 235 - 350 nm	More information
Holmium Oxide Solution cell	Wavelength Accuracy, 240 - 640 nm	More information
Potassium Chloride 10 & 5 mm cells	Stray Light, 190 - 205 nm	More information
Sodium Iodide 10 & 5 mm cells	Stray Light, 210 - 259 nm	More information
Acetone 10 & 5 mm cells	Stray Light, 250 - 320 nm	More information
Sodium Nitrite 10 & 5 mm cells	Stray Light, 300 - 385 nm	More information
Toluene in Hexane & blank cell	Resolution, 267 - 269 nm	More information

UV Qualification Set with Linearity Check	Part number RM-USP/3LIN	PRODUCT ENQUIRY
This set is the same as RM-USP, but contains two additional potassium dichromate references for checking photometric linearity.
Potassium Dichromate 60 mg/l & blank cell	Photometric Accuracy, 235 - 350 nm	More information
Potassium Dichromate 20 mg /l	Photometric Accuracy, 235 - 350 nm	More information
Potassium Dichromate 100 mg/l	Photometric Accuracy, 235 - 350 nm	More information
Holmium Oxide Solution cell	Wavelength Accuracy, 240 - 640 nm	More information
Potassium Chloride 10 & 5 mm cells	Stray Light, 190 - 205 nm	More information
Sodium Iodide 10 & 5 mm cells	Stray Light, 210 - 259 nm	More information
Acetone 10 & 5 mm cells	Stray Light, 250 - 320 nm	More information
Sodium Nitrite 10 & 5 mm cells	Stray Light, 300 - 385 nm	More information
Toluene in Hexane & blank cell	Resolution, 267 - 269 nm	More information

USP Visible Transmittance/ Absorbance and Wavelength Set	Part number RM-1N3N5DHG	PRODUCT ENQUIRY
These references are recommended in USP Chapter <857> for the qualification of spectrophotometers in the Visible region:
Absorbance Accuracy, 440-635 nm	Neutral Density Filters (1.00, 0.50 & 0.25 A)	More information
Wavelength Accuracy, 240 - 640 nm	Holmium Glass Filter	More information

NIST SRM Equivalent Sets:	More information	PRODUCT ENQUIRY
These SRMs are specifically cited in USP <857> as evidence of NIST traceability.
SRM 930e Set	Part number RM-1N2N3N
Absorbance Accuracy, 440-635 nm	Neutral Density Filters: 10, 20 & 30 %T
SRM 1930 Set	Part number N1N35N
Absorbance Accuracy, 440-635 nm	Neutral Density Filters: 1, 3 & 50 %T
SRM 2930 Set	Part number RM-D1D39N
Absorbance Accuracy, 440-635 nm	Neutral Density Filters 0.1, 0.3 &92 %T
Combined SRM Set:	Part Number RM-SRM9ND
Absorbance Accuracy, 440-635 nm	All 9 Neutral Density Filters listed above

UV Absorbance Scale & Linearity validation:	More information	PRODUCT ENQUIRY
For method validation, USP <857> recommends that absorbance linearity is checked with five or more analyte concentrations. The following Potassium Dichromate sets allow instrument linearity to be checked over the relevant absorbance range.
Photometric Linearity Set, 0.095A -1.5A	Part Number RM-0204060810
Potassium Dichromate 20, 40, 60, 80, 100 mg/l & blank cell
Photometric Linearity Set, 1.5A- 3.3A	Part Number RM-121416182224
Potassium Dichromate 120, 140, 160, 180, 220 & 240 mg/l & blank cell
Photometric Linearity Set, 0.19A - 3.3A	Part Number RM-040812162024
Potassium Dichromate 40, 80, 120, 160, 200 & 240 mg/l & blank cell

Tools for Easier Compliance
These comprehensive sets of Certified Reference Materials can be used to qualify ultraviolet and visible spectrophotometers according to the recommendations of both the US Pharmacopeia (Chapter <857>) and the European Pharmacopoeia (Chapter 2.2.25). Stray light filters are provided for both Specified wavelength and Filter Ratio Methods.
Combined USP/EP Qualification Set	Part number: RM-USP/EP	PRODUCT ENQUIRY
Potassium Dichromate 60 mg/l & blank cell	Photometric Accuracy 235 - 350 nm	More information
Potassium Dichromate 600 mg/l	Photometric Accuracy 430 nm	More information
Holmium Oxide Solution cell	Wavelength Accuracy 240 - 640 nm	More information
Potassium Chloride 10 & 5 mm cells	Stray Light 190-205 nm	More information
Sodium Iodide 10 & 5 mm cells	Stray Light 210 - 259 nm	More information
Acetone 10 & 5 mm cells	Stray Light 250 - 320 nm	More information
Sodium Nitrite 10 & 5 mm cells	Stray Light 300 - 385 nm	More information
Water blank 10 mm cell	Stray Light 190 - 400 nm	More information
Toluene in Hexane & blank cell	Resolution 267 - 269 nm	More information

Combined USP/EP Qualification Set with Linearity check	Part number: RM-USP/EP/3LIN	PRODUCT ENQUIRY
Potassium Dichromate 60 mg/l & blank cell	Photometric Accuracy, 235 - 350 nm	More information
Potassium Dichromate 20 mg /l	Photometric Accuracy, 235 - 350 nm	More information
Potassium Dichromate 100 mg/l	Photometric Accuracy, 235 - 350 nm	More information
Potassium Dichromate 600 mg/l	Photometric Accuracy 430 nm	More information
Holmium Oxide Solution cell	Wavelength Accuracy 240 - 640 nm	More information
Potassium Chloride 10 & 5 mm cells	Stray Light 190 - 205 nm	More information
Sodium Iodide 10 & 5 mm cells	Stray Light 210 - 259 nm	More information
Acetone 10 & 5 mm cells	Stray Light 250 - 320 nm	More information
Sodium Nitrite 10 & 5 mm cells	Stray Light 300 - 385 nm	More information
Water blank 10 mm cell	Stray Light 190 - 400 nm	More information
Toluene in Hexane & blank cell	Resolution 267 - 269 nm	More information

Tools for Easier Compliance
UV Visible Qualification Set	Part number: RM-EP	PRODUCT ENQUIRY
This set contains Starna Certified Reference Materials (CRMs) as specified by the European Pharmacopoeia (Chapter 2.2.25) for basic instrument qualification
Potassium Dichromate 60 mg/l & blank cell	Photometric Accuracy, 235 - 350 nm	More information
Potassium Dichromate 600 mg/l	Photometric Accuracy 430 nm	More information
Holmium Oxide Solution cell	Wavelength Accuracy, 240 - 640 nm	More information
Potassium Chloride 10 mm cell and blank cell	Stray Light, 190 - 205 nm	More information
Toluene in Hexane & blank cell	Resolution, 267 - 269 nm	More information

UV Visible Qualification Set with Linearity Check	Part number: RM-EP/3LIN	PRODUCT ENQUIRY
As RM-EP but with two additional Potassium Dichromate cells for checking photometric linearity:
Potassium Dichromate 60 mg/l & blank cell	Photometric Accuracy, 235 - 350 nm	More information
Potassium Dichromate 20 mg /l	Photometric Accuracy, 235 - 350 nm	More information
Potassium Dichromate 100 mg/l	Photometric Accuracy, 235 - 350 nm	More information
Potassium Dichromate 600 mg/l	Photometric Accuracy 430 nm	More information
Holmium Oxide Solution cell	Wavelength Accuracy, 240 - 640 nm	More information
Potassium Chloride 10 mm cell and blank cell	Stray Light, 190 - 205 nm	More information
Toluene in Hexane & blank cell	Resolution, 267 - 269 nm	More information

UV Visible Qualification Set with Derivative Resolution Check	Part number: RM-EP/TM	PRODUCT ENQUIRY
As RM-EP but with a Toluene in Methanol reference for checking Resolution in Derivative Spectroscopy as described in European Pharmacopoeia (Chapter 2.2.25)
Potassium Dichromate 60 mg/l & blank cell	Photometric Accuracy, 235 - 350 nm	More information
Potassium Dichromate 600 mg/l	Photometric Accuracy 430 nm	More information
Holmium Oxide Solution cell	Wavelength Accuracy, 240 - 640 nm	More information
Potassium Chloride 10 mm cell and blank cell	Stray Light, 190 - 205 nm	More information
Toluene in Hexane & blank cell	Resolution, 267 - 269 nm	More information
Toluene in Methanol & blank cell	Derivative resolution 267- 270 nm	More information

UV Visible Qualification Set with two Stray Light References	Part number: RM-EP/2SL	PRODUCT ENQUIRY
As RM-EP but with an additional Stray Light Reference
Potassium Dichromate 60 mg/l & blank cell	Photometric Accuracy, 235 - 350 nm	More information
Potassium Dichromate 600 mg/l	Photometric Accuracy 430 nm	More information
Holmium Oxide Solution cell	Wavelength Accuracy, 240 - 640 nm	More information
Potassium Chloride 10 mm cell and blank cell	Stray Light, 190 - 205 nm	More information
Sodium Iodide 10mm cell	Stray Light 260 nm	More information
Toluene in Hexane & blank cell	Resolution, 267 - 269 nm	More information

UV Visible Qualification Set with three Stray Light References	Part number: RM-EP/3SL	PRODUCT ENQUIRY
As RM-EP but with two additional Stray Light Reference
Potassium Dichromate 60 mg/l & blank cell	Photometric Accuracy, 235 - 350 nm	More information
Potassium Dichromate 600 mg/l	Photometric Accuracy 430 nm	More information
Holmium Oxide Solution cell	Wavelength Accuracy, 240 - 640 nm	More information
Potassium Chloride 10 mm cell and blank cell	Stray Light, 190 - 205 nm	More information
Sodium Iodide 10mm cell	Stray Light 260 nm	More information
Sodium Nitrite 10 mm cell	Stray Light 391 nm	More information
Toluene in Hexane & blank cell	Resolution, 267 - 269 nm	More information

In order to provide you with the best online experience this website uses cookies.

Cookie Policy

Technique

Visible References

Instrument Qualification Kits

Tools for Easier Compliance

Basic Qualification Kits

[Kit identity: RM-020610HLKCSIKISNTX]

United States Pharmacopoeia (USP) Instrument Qualification Sets