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