SUN TEN PHARMACEUTICAL CO., LTD.


	General Info Member Info

Manufacturing

Herb Authenticity

Flow Chart

Detailed Process

Sun Ten implements strict quality control starting from the raw herb materials received to manufacturing processes in order to ensure the safety, consistency and efficiency of every batch of our products. All herbs are authenticated by botanists. TLC is used for qualitative analysis, and HPLC is applied for both qualitative and quantitative analysis. Herbs and finished products are regularly tested for pesticides, heavy metals, and microbiological contamination to ensure products safety.

We use HPLC analysis to identify the active constituents found in the herbs, so of now, Sun Ten has isolated the active constitutes of over 80 plants. HPLC qualitative/quantitative analyses have shown great consistency amongst multiple batches of Sun Ten products.



	Our Quality Assurance teams routinely execute the following QC tests to ensure safety and high quality products: Macroscopic (visual) inspection: authenticate the herb species and parts used. Microscopic examination: authenticate the herb species by histological examination and comparison with certified reference standard specimen. TLC (thin layer chromatography): verify the identity of herb species by comparing its unique analytical identification with certified reference standard herb. HPLC/PDA (high performance liquid chromatography coupled photo diode array detector): measure potency and batch consistency by quantifying the content of active ingredients. HPLC/ELSD (high performance liquid chromatography coupled evaporative light scattering detector): determine the quality of rehmannia by analyzing its S to M saccharide ratio. ICP/MS (gas chromatography coupled mass spectrometry): measure heavy metal elements to ensure product safety. GC/MS (gas chromatography coupled mass spectrometry): screen for pesticide residue to ensure product safety. HPLC/FD (coupled fluorescent detector): check the content of aflatoxin to ensure product safety. LC/MS (coupled mass spectrometry): screen for the existence of aristolochic acid to ensure product safety. Microbiological testing: analyze yeast & mold and pathogenic microorganism to ensure product safety.


	A COA for every batch of production is approved and issued by the Head of Quality Assurance to ensure that the products meet international safety and quality standards prior to market release.


	From the lot number of any given finished product, Sun Ten is able to trace to its batch record and link to its retained raw herb sample lot and Certificate of Analysis.


	Product batch-to-batch consistency is one of the most challenging tasks for herbal extract products because the botanical materials are primarily derived from nature source and quality of these natural sources is greatly influenced by the place of origin, weather condition, harvest season, and storage and processing condition. However, Sun Ten inspects and monitors its botanical materials from the cultivation sites, and applies innovative manufacturing technology to ensure product batch-to-batch consistency. Product batch-to-batch consistency derives from raw herb source with high consistent quality and by consistent production practice under GMP guidelines.


	High Performance Liquid Chromatography (HPLC) is used to analyze the content of the bio-active constituents in every batch of botanical materials in order to ensure product efficacy and batch-to-batch consistency. The lower variance of different batch of botanical materials will ensure the consistency, efficacy, and quality of the final product.

SUN TEN PHARMACEUTICAL CO., LTD
TEL: 886-2-8978-5799 ;FAX:886-2-8913-2338
3F., No.207, Sec. 3, Beixin Rd., Xindian Dist., New Taipei City 23143, Taiwan (R.O.C.)