Prinbury Pharmaceutical Analytical Development (PAD) department is primarily responsible for analytical R&D for both drug substances and drug products.
PAD is equipped with a group of high qualified research scientist and comprehensive management system, PAD has established high-standard pharmaceutical analytical laboratories.
Furthermore, PAD has featured a well-organized and target-efficient functional modules by a feasible combination of a state-of-the-art laboratory instruments and a series of analytical technology platform.
w Extractable and leachable (E&L), genotoxic impurities (GTI), elemental impurity (EI) studies and unknown impurity identification (UI).Formulation support, analytical method development and optimization, analytical method verification/validation, comparative dissolution study, development and formal stability testing;
w Reverse engineering, excipient compatibility study, and CMC documents writing;
w Extractable and leachable (E&L), genotoxic impurities (GTI), elemental impurity (EI) studies and unknown impurity identification (UI).
w High-performance liquid chromatography (HPLC), equipped with UV, ELSD, RID detectors;
w Liquid chromatography-mass spectrometry (LC-MS) equipped with TQ (LC-MS/MS), TOF (LC-QTOF) detectors;
w Gas chromatography (GC), equipped with FID (GC-FID), MS (GC-MS) detectors;
w Inductively coupled plasma mass spectrometry (ICP-MS);
w Dissolution apparatus complies USP method 1, 2, and 3;
w Particle size analyzer at micro/nanometer scale, equipped with zeta-potential detector;
w Binder series stability chambers, et al.
w High-level and full-skilled staff;
w Professionals experts leadership;
w Collaborations with top universities and institutes.
Extractable and leachable study
The PAD E&L team has developed a scientific R&D process based on product process characteristics (included but not limited to): Extractable study; Simulated leachable study; Toxicological evaluation of potential leachates; Leachable method development, and Formal leachable study.
Research scope: plastic bottles; aluminum tube;
penicillin bottles and rubber plugs ;
Dosage form: liquid formulations, semisolid formulations
and injectables
Commitments: meet the requirements of domestic
and international drug application; support customer audits and inspection of administrators.
Genotoxic impurity study
The PAD GTI team has accumulated sufficient professional experiences and has completed GTI study of several categories.
Research scope: N-nitrosamines, sulfonate
esters and NDSRIs;
Instruments: GC-FID, GC-MS, GC-HS-MS, LC-MS(scan, SIM, MRM).
Commitments: support evaluation of genotoxic impurities.
Unknown impurity identification
The PAD UI team can customize the research plan according to the customer’s requirements.
Research scope: enrich the target unknown
impurity through force degradation, concentration, preparation, purification
and other technical method;
Instruments: high-resolution mass spectrometry (LC-QTOF-MSMS);
Commitments: quickly obtain the MSn
mass spectra of the target impurity; identify and confirm the structure; provide
the value-added services such as impurity characterization, impurity preparation
and QSAR evaluation in compliance with customers` needs.