Consistency & Verification

Batch-to-Batch Consistency

Batch-to-batch product consistency is one of the most challenging tasks for herbal extract products. As raw materials are primarily derived from natural sources and quality of these natural sources is greatly influenced by their place of origin, weather condition, harvest season, storage and processing condition. However, SUN TEN applies science and technology to transform ancient wisdom into modern scientific standard of compliance and fulfils the fundamental requirements of product consistency and stability. Product batch-to-batch consistency derives from high consistent quality of raw herb source and consistent proactive production under GMP guidelines. 

Controlled manufacturing environment of a GMP compliant facility encourages qualified raw material sourcing, constituent verification, and product consistency due to established SOP (standard operating procedures) that creates congruency and precision. 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 to ensure consistency and efficacy.

Consistent Geniposide Level(mg/g) in Different Batches of shan Zhi zi (Raw Herb)

                   Number of batches

Constituent Verification

HPLC fingerprinting is used to analyze the content of the active ingredients in raw source materials and final products as well as tracking 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 feature of batch-to-batch consistency.

HPLC Radar Graph of Three Selected Batches of Jia Wei Xiao Yao San produced by Different Manufacturers
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