Consistency & Verification
Batch-to-batch product consistency is one of the most challenging tasks for herbal products. Raw materials are derived from natural sources, where quality is greatly influenced by factors such as region of origin, weather conditions, harvest season, storage, and processing conditions. However, SUN TEN applies science and technology to transform ancient wisdom into modern unyielding product consistency and stability while complying to GMP guidelines.
The controlled manufacturing environment of a GMP-compliant facility encourages qualified raw material sourcing and product consistency due to established standard operating procedures. In order to verify consistency SUN TEN uses HPLC/TCL analyses to identify the active constituents present in the final product. HPLC quantitative analyses have shown minimum variation amongst multiple batches of SUN TEN products, which proves our efficacy and consistency.
Consistent Geniposide Level(mg/g) in Different Batches of shan Zhi zi (Raw Herb)
Number of batches
HPLC fingerprinting is used to analyze the content of the active ingredients in raw source materials and final products as well as to track their variance among different batches. The lower the variance among different production batches, the higher the consistency of the quality in the final product. Batch-to-batch consistency in the active ingredients between different batches of the same product can be easily compared when they are displayed in radar graph. Quality control starting from raw herb sourcing to production of Jia Wei Xiao Yao San is used as an example to demonstrate SUN TEN’s impressive batch-to-batch consistency.
HPLC Radar Graph of Three Selected Batches of Jia Wei Xiao Yao San produced by Different Manufacturers
A: SUN TEN
B-D: Other Brands'
B: Geniposide (GP) is very high in three batches but the quantity of remaining markers is not consistent in other batches
C & D: Quantity of all markers is not consistent among batches