The quality control system behind Disugar® mulberry leaf extract

01Source

Where to buy and when to harvest, decided by multi-region field data

6 growing regions · 72 lots · 1-DNJ assayed by HPLC across region, harvest month and leaf position
Variable controlled
1-DNJ content varies markedly with growing region, harvest month and leaf position: the same region differs by month, and the same plant differs by leaf position
How
Multi-year sampling of the main growing regions with HPLC assay and statistical analysis, building a region × harvest-window × 1-DNJ database used to lock in the regions and harvest windows capable of stable volume supply
Proof
Raw-material field survey report: content ranges and statistical analysis across six regions and 72 lots over two years; HPLC records for the raw material
72lots
Raw-material survey sample size, two years
6regions
Core regions A and B supply at volume
May
Harvest window with high, stable content
REGION · 1-DNJ RANGE (%) Core region A median 0.130 Core region B median 0.138 Region C median 0.126 Region D median 0.110 Region E median 0.080 Region F median 0.190 · few lots 00.100.200.30 HARVEST MONTH Apr May Jun occasional high lotshigh and stable · harvest windowlower overall LEAF POSITION · CONTENT DECLINES DOWN THE SHOOT Bud Young Mature Old
02Process

A membrane separation line built on four granted patents

Compliant water extraction · no organic solvent residue · integrated production line
Variable controlled
Batch-to-batch consistency of extraction conditions, microbial control and filtration; solvent-residue risk
How
Extraction with food-grade purified water; fine filtration → ultrafiltration → nanofiltration; UHT sterilisation for microbial control
Proof
4 granted patents plus 3 pending applications; no organic solvent is used, hence no solvent-residue test item
Core patented technologyPatent no.Problem solved
Filter cartridge and mulberry leaf extraction methodZL2023 1 1584306.1Retains active constituents while effectively removing mycotoxins
Multi-stage high-temperature sterilisation tankZL2023 2 2371120.XMeets microbial control requirements while fully preserving nutrients and active constituents
Filtration device for plant extractsZL2023 2 2271125.2Efficient and energy-saving; keeps filtration conditions consistent between batches
Preparation device for readily soluble mulberry leaf extractZL2022 2 1635974.3Instant, clear solution in the finished powder
03Product

Delivered on verifiable specifications

Marker content · dissolution and clarity · stability · safety risk indicators
Variable controlled
Marker content, dissolution and clarity, stability across pH and in alcohol systems, safety risk indicators
How
Delivered on 1-DNJ as the marker, quantified by HPLC; release testing on every batch of both grades, covering content, moisture, particle size, four heavy metals and seven microbiological items; an improved-taste version is available for dairy and tea systems
Proof
Release test report and COA for every batch, supplied with the shipment; third-party type-inspection reports (DNJ 1% by Mérieux, CMA/CNAS; DNJ 5% by SGS, CNAS); technical data sheet (TDS)
5.23–5.39%
Measured range across four DNJ 5% batches
0.16pt
Batch-to-batch spread
24months
Shelf life · sealed, dry storage
DNJ 5% GRADE · MEASURED CONTENT BY BATCH (%) Spec ≥ 5.0 5.23260101 5.39260102 5.38260401 5.30260604
04Endorsement

Safety and activity are not self-certified

GLP toxicology · third-party activity testing · certifications
Variable controlled
Safety and activity
How
DNJ 1% grade: safety studies commissioned to an NMPA GLP-certified laboratory under GLP conditions; in-vitro activity testing commissioned to the China National Research Institute of Food and Fermentation Industries
Proof
GLP study report (with report and GLP certificate numbers); third-party activity test report; management-system and market-access certificates; Disugar® registered in Class 5 in China (No. 65059872) and the United States (Reg. 8,046,356)

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