Quality control is an essential element in pharmaceutical manufacturing to ensure efficacy and safety of medicinal products. Sun Ten evaluates quality at all stages of the herbal manufacturing process.
1. Dao Di Sourcing
Sun Ten carefully investigates herb origins and selects raw herbs directly through long-term partnerships with cultivation sites, some of which are CITES approved. Raw materials are not purchased directly from the public market to avoid issues such as non-authentic herbs, contamination, toxicity or lacing, or those with inferior constituent ratios.
2. Stock Management
Carefully packed and labelled herbs are kept under temperature and humidity control prior to processing to ensure optimal condition of botanical materials.
3. Herb Authentication
Prior to acquisition of the source herbs, sample materials undergo verification of authenticity and quality, including:
- Macroscopic visual inspection to authenticate herb species and parts used.
- Microscopic Histological ID to authenticate the herb species by histological examination and comparison with certified reference standard specimen.
- TLC (thin layer chromatography) to verify the identity of herb species by
comparing its unique analytical identification with certified reference standard herb.
- HPLC (High Performance Liquid Chromatography) to analyse the content of the bioactive constituents in each batch of botanical materials.
4. Contamination Testing
Raw herbs and finished products are regularly tested for heavy metals, microbiological contamination, aflatoxin and pesticides to ensure safety.
- ICP/MS (gas chromatography coupled mass spectrometry) measures heavy metal elements.
- GC/MS (gas chromatography coupled mass spectrometry) screens for pesticide residue.
- HPLC/FD (coupled fluorescent detector) checks the content of aflatoxin.
- LC/MS (coupled mass spectrometry) screens for the existence of aristolochic acid.
- Microbiological testing analyses yeast, mold and pathogenic microorganism levels.
Sun Ten Pharmaceutical Analysis & HerBiotek Laboratories have an extensive scope of accreditations for testing, including:
- B 001 Total Aerobic plate counts
- B 004 Escherichia coli
- B 007 Staphylococcus aureus
- B 008 Salmonella species
- B 010 Yeast & moldcounts
- B 013 Pseudomonas aeruginosa
- B 041 Bile-tolerant Gram-negative bacteria
- B 501 Origin of Herbs Identification
- C 070 Heavy Metal
- C 157 Aflatoxins B1 B2 G1 G2
- C 170 Aconitine, Hypaconitine & Mesaconitin
- C 170 Senecionine & Senkirkine
- C 170 Ephedrine & Pseudoephedrine
- C 170 Tetrahydropalmatine
- C 402 Aristolochic acid
5. Constituent Verification
After concentrated, constituents of each formula are verified for contents and potency of active ingredients to ensure efficacy and safety.
- HPLC/PDA (high performance liquid chromatography coupled photo diode array detector) measures potency and batch consistency.
- HPLC/ELSD (high performance liquid chromatography coupled evaporative light scattering detector) determines the quality of Da Huang by analyzing its S to M saccharide ratio.
6. Certificate of Analysis (COA)
A COA for every batch of production is approved and issued by the Head of Quality Assurance to ensure the products meet international safety and quality standards prior to export to Australia. Using the Lot number stated on any certificate, Sun Ten is easily able to trace a product to its batch record and to its retained raw herb sample.