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This kit has been designed to assist  compliance with the requirement for drug photostability testing imposed by the International Conference of Harmonisation’s Q1B stability testing guidelines.

In 1996, the ICH (International Conference On Harmonisation) issued its Q1B guideline stating that thephotostability characteristics of new drug substances and products should be evaluated to demonstrate that exposure to light does not result in unacceptable change.

The substance under test is exposed to ultra-violet light under controlled conditions, using quinine as an actinometry standard, exposed under the same conditions.

The kit contains four special cells, each with a PTFE screw cap to ensure that samples only come into contact with  inert materials. They are engraved and used as follows:

1. Sample – Test cuvette, to be filled with sample under evaluation for exposure to radiation.

2. Control – Test cuvette, to be filled with sample under evaluation, and then wrapped in aluminium foil to protect completely from light, and used as the control.

3. Q Sam. – Calibration cuvette, to be filled with Quinine solution for exposure to radiation.

4. Q Ref. – Reference cuvette, to be filled with Quinine solution, and then wrapped in aluminium foil to protect completely from light, and used as the reference.

Full instructions for use are provided with each kit.

 
 

 

 

 
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These reference materials have been specially developed for the validation of DNA purity measurements when performed with the dedicated low volume (< 5 ul) and short path length (< 1 mm) instrumentation offered by several vendors for use in genomics and proteomics, when sample is often at a premium. They are also ideal for qualifying conventional instruments when they are used with ultra- low volume cells such as the Starna DMV-Bio cell.

The references are supplied in vials with screw-cap closure for ease of handling, and from which it is easy to transfer them to the instrument under test using a micropipette or syringe. Each vial contains 1.5 ml of DNACON solution.

The DNACON reference from Starna was developed as a reliable, stable and NIST traceable reference material for the validation of this method.  The reference consists of a solution of a synthetic material whose spectral characteristics closely mimic those of pure DNA, but does not suffer from the instability and other difficulties associated with DNA itself. Two concentrations are available in vial format, to give absorbances of approximately 1 A or 0.5 A at a nominal path length of 1mm.

 

 DNACON Microvolume References

 

DNACON

 Absorbance values are certified at 260 nm, 280 nm and 330 nm for spectral bandwidths of 1.0, 2.0, 3.0, 4.0 and 5.0 nm . The value at 330 nm is used as a “background” correction, as in the normal methodology. From these values a corrected 260/280 ratio is calculated and reported for each bandwidth using the formula:

Ratio =   (A260 – A330)
                    (A280 – A330)

The typical calculated ratio is 1.9

 

A Certificate of Calibration and Traceability and full instructions for use are provided with each Reference Material. Starna Scientific is accredited to both ISO 17034 (4001) as a Reference Material producer, and ISO/IEC 17025 (0659) as a Calibration Laboratory for optical reference measurements. Starna offers a Lifetime Guarantee on all its Reference Materials.

 

 

 
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The Starna DNACON Reference can be used for quality control and assurance of nucleic acid purity measurements using the 260/280 nm ratio method.

The ratio of the UV absorbance values at 260 nm and 280 nm is an important method for determining the purity of nucleic acid preparations, but validation actual DNA solutions is unreliable as such solutions are difficult to produce and inherently unstable. The DNACON reference from Starna was developed as a reliable, stable and NIST traceable reference material for the validation of this method. The reference consists of a solution of a synthetic material whose spectral characteristics closely mimic those of DNA, permanently heat-sealed in a far-UV quartz cell. By replicating an actual DNA sample, DNACON gives a reliable direct indication of the quality of the overall measurement process.

 

 DNA CON 

DNACON

Absorbance values are certified at 260 nm, 280 nm and 330 nm for spectral bandwidths of 1.0, 2.0, 3.0, 4.0 and 5.0 nm . The value at 330 nm is used as a “background” correction, as in the normal methodology. From these values a corrected 260/280 ratio is calculated and reported for each bandwidth using the formula:

Ratio =      (A260 – A330)

_______________

(A280 – A330)

The typical calculated ratio is 1.9

 

A Certificate of Calibration and Traceability and full instructions for use are provided with each Reference Material. Starna Scientific is accredited to both ISO 17034 (4001) as a Reference Material producer, and ISO/IEC 17025 (0659) as a Calibration Laboratory for optical reference measurements. Starna offers a Lifetime Guarantee on all its Reference Materials.

 

 

dtarn-green-micro-small

Purpose 

These reference materials have been specially developed for the qualification of the dedicated low volume (< 5 ul) and short path length (< 1 mm) instrumentation offered by several vendors for use when sample is often at a premium. They are also ideal for qualifying conventional instruments when they are used with ultra-low-volume cells such as the Starna DMV cell. As the use of these references involves their physical transfer by the user in to the measuring device, this material is fully REACH compliant.  

Description and Discussion 

Many microvolume spectrophotometers have relatively wide spectral bandwidths, up to 8 nm in some cases. Most reference materials available for instrument wavelength qualification are chosen for their well-defined spectra, with sharp absorption bands, and are usually recommended for instruments with spectral bandwidths of 3 nm or less. This is partly because most absorption bands are asymmetric, so the apparent peak wavelength will change with bandwidth, and partly because wider bandwidth instruments may be unable to resolve some peaks at all. References with sharp absorption bands may therefore be unsuitable for the qualification of these instruments.

The use of aqueous dye solutions, however, is an established and well-recognised method for the validation of the absorbance scale and linearity of a spectrophotometer. Starna Green is a specially formulated, highly stable dye solution with three broad but well-defined peaks that can be certified for both wavelength and absorbance value in the UV and visible regions, at bandwidths up to 20nm.

 

starna-green-100

The reference is formulated to give an approximate absorbance of 1A at each of the certified wavelengths, 258, 416 and 630 nm, at a nominal path length of 1 mm.

The references are supplied in vials with screw-cap closure for ease of handling, and from which it is easy to transfer them to the instrument under test using a micropipette or syringe. Each vial contains 1.5 ml of Starna Green solution.

How to Order

  Catalogue Number
Starna Green Microvolume reference, 1 x 1.5 ml vial RM-SG10-SC1  
Starna Green Microvolume reference, 2 x 1.5 ml vials RM-SG10-SC2  
Starna Green Microvolume reference, 4 x 1.5 ml vials RM-SG10-SC4 

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The life sciences have special requirements for instrument and method validation. In genomics and pharmaceutical chemistry in particular, limitations in sample availability and the very high cost of some reagents have led to the need to measure very small sample volumes. The need for high sample throughput is another pressure and has led to the development of highly automated procedures. The analytical equipment developed to meet these demands may not be compatible with conventional cell- or filter-based reference materials. This is, however, one of the most heavily regulated  fields in science, so reliable and traceable reference materials are a fundamental component of any quality programme, and essential for meeting guidelines such as GLP and GMP.

Starna has developed a range of reference materials tailored to the special needs of this important sector.

This is a rapidly developing field, and Starna is ideally placed to assist with the development of reference materials for use in novel applications. Please contact us with your  requirements.

Starna DNACON

 rm-dna

This Reference Material was developed as a reliable, stable and NIST traceable reference  for the validation of nucleic acid purity measurements by the 260/280 nm ratio method.

The reference cell contains a solution of a synthetic material whose spectral  characteristics closely mimic those of DNA. By replicating an actual DNA sample, DNACON gives a reliable direct indication  of the quality of the overall measurement process. It is also available for use in microvolume instruments.

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DNACON Microvolume References

DNACON Microvolume References 

Starna can supply DNACON specially packaged for  the qualification of dedicated drop technology and other low volume instrumentation, where sample volume is often below one  microlitre. Supplied in vials with either screw-cap or septum closures for ease of handling, they are also ideal for qualifying conventional instruments used with ultra- low volume cells such as the Starna  DMV-Bio cell. 

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Starna Green Microvolume References

dtarn-green-micro-small

Not all microvolume measurements are conducted on DNA, so the popular Starna Green reference is also available in vial format to provide a general purpose qualification for both wavelength and absorbance.

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Drug Photostability Testing Kit

 rm-photostability g 1

This kit has been designed to assist compliance with the requirement for drug photostability testing imposed by the International Conference of Harmonisation's Q1B stability testing guidelines. Quinine is used as an Actinometry Standard.

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