Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Application

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

The solubility of lipophilic drugs increases linearly with the concentration of hydroxypropyl-β-cyclodextrin (HBC) in aqueous solution because of the complex between HBC and the drug. This guest-host type complex is formed between the drug and the non-polar cavity in the HBC that results in enhanced solubility. Solutions may be lyophilized to produce freely soluble powders. Non-toxic in rabbits and mice.

Hydroxypropyl Beta Cyclodextrin may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and serum samples by various chromatographic and electroanalytical techniques.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAA2748 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

General description

Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.