Pharmaceutical Services
Pharmacopoeia Methods
According to Ph. Eur., USP, BP, and JP
Heparins & Heparinoids
Heparin Injection
Hydroxypropyl Betadex
Lauromacrogol 400
Octreotide
Poloxamer
Cetostearyl Ether
Heparins & Heparinoids
We analyze heparin preparations such as sodium heparin, calcium heparin, and low molecular weight heparins according to the requirements of the European, US, British, and Japanese pharmacopoeias. Using ¹H-NMR spectroscopy, we reliably test structural identity, purity, and sulfation pattern – essential for quality assurance and release of heparin APIs.
Heparin Injection
For heparin injection solutions, we perform quality analyses according to the British Pharmacopoeia (BP). NMR spectroscopy provides critical insights into structural integrity, homogeneity, and batch conformity – a key element of pharmaceutical safety.
Hydroxypropyl Betadex
Our analyses according to Ph. Eur. and USP specifically determine the degree and pattern of substitution as well as purity of hydroxypropyl betadex. NMR spectroscopy is the central tool to verify structural specifications and demonstrate compliance with regulatory requirements.
Lauromacrogol 400
For Lauromacrogol 400, we perform structure-elucidating NMR analyses to verify the polyethylene glycol chain structure and the degree of alkylation according to Ph. Eur. This ensures consistent quality in the production and release of this local anesthetic.
Octreotide
Octreotide, a synthetic peptide with hormone-like activity, is tested for identity, purity, and structural integrity according to Ph. Eur. Using NMR, we ensure that the sequence and conformation match the monograph specifications – essential for therapeutic safety and efficacy.
Poloxamer
Poloxamers require precise analytics of the polyoxyethylene-to-polyoxypropylene ratio. Our NMR methods enable qualitative and quantitative characterization of these non-ionic surfactants according to Ph. Eur. and USP – ensuring their reliable use in pharmaceutical formulations.
Cetostearyl Ether
For cetostearyl ether, we offer identity and purity testing according to USP. NMR spectroscopy allows clear confirmation of the structure and composition of this complex fatty alcohol mixture – a crucial step for excipient release.