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Reverse Engineering Study for Drug Products
We have accumulated various pre-treatment means and chromatographic systems for the characterization and quantification of pharmaceutical excipients, and can provide customers with efficient and high-quality reverse engineering study services to enhance the efficiency and success rate of R&D.
Test articles | Method description |
Metal ions and excipients containing metal ions | ICP-MS、ICP-OES、AA |
HPMC | HPLC-RID |
Starch | Optical rotation method |
Povidone | HPLC-UV |
Polyvinylacetat-Polyvinylpyrrolidon | HPLC-UV |
Metallic calcium or excipients containing calcium | ICP-OES |
Lactose | HPLC-RID |
Sucrose | HPLC-RID |
Inorganic ions and excipients containing inorganic ions | IC |
Phospholipids | HPLC-ELSD |
Sodium caprylate | GC |
Acetyltryptophan | HPLC |
Histidine | HPLC determination after derivatization |
Corn starch | Titration after hydrolysis |
Liposome characterization (morphology, PEG thickness, phase transition temperature, particle size, and Zeta potential, etc.) | Use of Malvern particle size analyzer, electron microscope, DSC and other instruments |
Characterization of poly (lactid-glycolide acid) (PLGA) (LA/GA molar ratio, capping, block ratio, molecular weight, chain structure, Tg, and crystal form, etc.) | 1H-NMR, 13C-NMR, quantitative 13C-NMR, GPC, DSC, XRPD, Raman, etc. |
PLGA content | Quantitative 1H-NMR |
Residual monomer in PLGA | GC、HPLC-UV |
Characterization of sodium carboxymethylcellulose (CMC-Na) (molecular weight, degree of substitution) | GPC, potentiometric titration, quantitative 13C-NMR |
Content of CMC-Na, D-mannitol, Poloxam 188, Tween 80 | HPLC-RID、HPLC-ELSD、UV |
Na+ content | Potentiometric titration |
Acetic acid content | GC、HPLC |
Polyvinyl alcohol (PVA) content | HPLC-RID |