Quality is a crucial factor at Reference Analytics. Especially in customer support we place the highest value on quality to meet the highest expectations. We make an essential contribution to the quality of medicinal products and create significant added value for our customers.
Development and validation
Literature research
Development of analytical methods
Validation of analytical methods incl.
Standard validation
Transfer validation
Revalidation
Validations are performed according to ICH guidelines and include the following risk-based parameters
Specificity
Linearity
Accuracy
Precision
Limit of detection
Limit of quantification
Range
Robustness
Method verification
Product specific verification of test method
Quality control according to pharmacopoeia (Pharm. Eur., Ph. Helv., USP, …)
Complete examination according to monograph
Identity check
Purity testing
Limit testing
Assay of content
Further development is an important part of our philosophy, therefore we are constantly expanding our range of services.
If your desired method is not included here, please do not hesitate to contact us!