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Address
B501 Changsheng Business Building, No. 26 Daguan South Road, Tianhe District, Guangzhou City
Guangzhou Xinpu Lei Scientific Instrument Co., Ltd
B501 Changsheng Business Building, No. 26 Daguan South Road, Tianhe District, Guangzhou City
1、 Product Overview
with2025The fourth section of the annual edition of the Chinese Pharmacopoeia officially includes mannitol in the standard system for pharmaceutical excipients, and specifies the use of high-performance liquid chromatography for the "related substances" and "content determination" items. The market demand for specialized chromatography columns that meet the requirements of the Pharmacopoeia is increasing day by day. In response to this background, Guangzhou Xinpu Lei Scientific Instrument Co., Ltd(SimplyLab)LaunchedSimpSil Sugar-CaSugar alcohol specific column.
This chromatographic column uses sulfonated crosslinked styrene-Diethylbenzene copolymer is used as the matrix, filled with strong cationic calcium type exchangers, specifically for the separation of mannitol and its structural analogues, fully meeting the requirements2025The technical requirements for the detection of mannitol in the annual edition of the Chinese Pharmacopoeia.
2、 Core parameters and ordering information
· brand:SimplyLab
· product name:SimpSil Sugar-CaSugar alcohol dedicated column
· Item Number:SGSC-307805
· specification:5μm,7.8×300mm
· Fixed phase structureSulfonated cross-linked styrene-Diethylbenzene copolymer(PS/DVB),Ca²⁺type
· Separation modeLigand exchange chromatography
· USPClassification:L19
3、 Technical background and compliance with pharmacopoeia
according to2025According to the fourth part of the Chinese Pharmacopoeia, the chromatographic column for detecting mannitol must meet the following characteristics:
· Type of fillerSulfonated crosslinked styrene-Strong cation calcium exchange column with diethylbenzene copolymer as filler.
· Separation requirementsThe separation degree between the mannitol peak and the sorbitol peak (system suitability solution) should be greater than 2.0.
SimplyLab SimpSil Sugar-Ca(SGSC-307805)Design strictly according to this standard,5μmThe particle size provides higher column efficiency and resolution, which helps in 80℃Under column temperature and pure water mobile phase conditions, accurately separate mannitol, sorbitol, maltitol, and isomaltitol.
4、 Typical chromatographic conditions
To comply with2025The Chinese Pharmacopoeia requires the following conditions for testing mannitol:
project |
Recommended parameters |
chromatographic column |
SimpSil Sugar-Ca,5μm,7.8×300mm(Item number:SGSC-307805) |
Protective column (optional) |
SimpSil Sugar-Ca Guard |
mobile phase |
Pure water (via0.45μmMembrane filtration and degassing |
flow velocity |
0.5 mL/min |
column temperature |
80℃ |
detector |
Differential refractive index detector(RI), Temperature40~55℃ |
injection volume |
20-25 μL |
5、 Technical advantages
1. High separation efficiency: Adopting5μmSmall particle size packing with high theoretical tray number ensures sharper peak shapes and higher separation of mannitol and sorbitol in high-temperature analysis, surpassing pharmacopoeia standards.
2. Strong tolerance: Based on polymer matrixPS/DVBThe skeleton has extremely high chemical and thermal stability, and can withstand80-85℃High temperature operation prolongs the service life of chromatography columns.
3. Compatible with pure water phaseSpecially designed for100%The design of aqueous mobile phase eliminates the need for organic solvents, reduces operating costs, and is environmentally friendly.
4. Low column lossStable sulfonation process and calcium ion loading ensure baseline stability and high signal-to-noise ratio under differential refractive index detector.
5. complianceThe specifications and filling types of the chromatographic column are completely consistent2025The requirements for the analysis of substances related to mannitol in the annual edition of the Chinese Pharmacopoeia.
6、 Application Fields
· pharmaceutical industryInspection and content determination of related substances (such as sorbitol, maltitol, etc.) in mannitol raw materials and injections.
· food testingSeparation and quantification of sugar alcohol sweeteners (mannitol, xylitol, xylitol) in food.
· Auxiliary material controlQuality control of mannitol as a pharmaceutical excipient.