The Chinese Pharmacopoeia 2025 Edition*, Part IV, the monograph for Lactose, analysis by high‑performance liquid chromatography specifies the use of a column packed with amino silica or amino polymer gel. HILICpak VG-50 4E column confirmed the requirement was met.
System suitability requirementResolution between lactose and sucrose: > 1.5
*The version at the time of the application acquisition.
Sample: 10 µL
5 mg/mL each in H2O/CH3CN=50/50
- 1.Sucrose
- 2.Lactose

- Column
- :Shodex HILICpak VG-50 4E (4.6 mm I.D. x 250 mm)
- Eluent
- :H2O/CH3CN=30/70
- Flow rate
- :1.0 mL/min
- Detector
- :RI (30 ℃)
- Column temp.
- :30 ℃
Sample Name Index
Operation Manual / Certificate of Analysis
Operation Manuals and Certificate of Analysis / Inspection Certificate for the following products can be downloaded here.
Product Name Index
Applications
- Analysis of Sucrose Stearate According to Chinese Pharmacopoeia 2025 Edition (KF-802)
- Analysis of Sucrose Palmitate According to Pharmaceutical Excipient Standards of Chinese Pharmacopoeia (Draft, Public Consultation) (KF-802)
- Analysis of Glycerin According to Pharmaceutical Excipient Standards of Chinese Pharmacopoeia for “Glyceryl Tricaprylate” (Draft, Second Public Consultation) (KF-802)
- Analysis of Mannitol in According to Chinese Pharmacopoeia 2025 Edition Standard (SC1011)
- Analysis of Lactitol Monohydrate According to Pharmaceutical Excipient Standards of Chinese Pharmacopoeia (Draft, Public Consultation) (SC1011)
- Analysis of Glucose, Sorbitol, and 1,6‑Anhydro‑β‑D‑Glucose in Polydextrose According to Chinese Pharmacopoeia 2025 Edition (SC1011)
- Analysis of Maltitol According to Chinese Pharmacopoeia 2025 Edition (SC1011)
- Analysis of Dextran 20 and Dextran 40 According to Chinese Pharmacopoeia 2025 Edition (SB‑803 HQ)
- Analysis of Four Saccharides in Honey According to Chinese Pharmacopoeia 2025 Edition (NH2P‑50 4E)
- Analysis of Citrate Ion According to Chinese Pharmacopoeia 2025 Edition (SH1011)
- Analysis of Trehalose According to Chinese Pharmacopoeia 2025 Edition (KS-801)
- Analysis of Sugars and Sugar Alcohols in Human Blood Products According to Chinese Pharmacopoeia 2025 Edition (SH1011)
- Analysis of Human Serum Albumin Multimers According to Chinese Pharmacopoeia 2025 Edition (KW-803)
- Analysis of IgG Monomers and Dimers in Human Immunoglobulin Preparations According to Chinese Pharmacopoeia 2025 Edition (KW-803)
- Analysis of Erythritol According to Pharmaceutical Excipient Standards of Chinese Pharmacopoeia (Draft, Public Consultation) (SH1011)
