At Standalix, we specialize in high-purity reference standards to meet the evolving needs of pharmaceutical research, quality control and regulatory compliance. We support pharmaceutical companies and quality control laboratories with reliable, readily available API impurity standards that meet the most stringent global regulations.
Our Reference Standards
Our product range includes API impurity standards designed to support comprehensive purity profiling and stability studies along with nitrosamine standards tailored to help laboratories meet the latest EMA, FDA, and global regulatory requirements.
With a catalogue
Each reference is meticulously developed to support R&D and quality control departments in ensuring regulatory compliance, product safety, and performance throughout drug development and manufacturing.
Your premier destination for superior API impurity standards and quality control chemicals in Europe.
Value Prop Pillars
- Extensive Catalogue
- Custom Sourcing
- Analytical-grade quality
- Cost-efficient solutions
- Fast response
- …
Frequently asked questions
What type of reference standards does Standalix offer?
We provide pharmaceutical-grade API impurity standards and nitrosamine standards, designed to support drug method development, stability studies, and quality control processes.
Are Standalix standards compliant with international regulations?
Yes. All our standards are developed in accordance with EMA, FDA, and ICH guidelines to ensure global regulatory compliance.
Which certificates does Standalix supply with its reference standards?
Each standard is accompanied by essential analytical data including NMR, HPLC, Mass Spectrometry, and TGA. Additional tests can be performed upon request.
Does Standalix offer tailored compounds for specific requirements?
Absolutely. We offer custom development of complex R&D standards as well as isolation and structure elucidation of unknown impurities.
How can I request a quotation or sample?
You can contact us via our [contact form] or email our support team directly. We will get back to you promptly with availability and pricing details.
Is Standalix open to distribution partnerships?
Yes. We collaborate with trusted partners worldwide. If you’re interested in becoming a distributor, please contact us through our business inquiries channel.