Principals：Hubei Magic Health Technology Co., Ltd.
Manufacturer：ANGEL YEAST CO., LTD
Effective date：December 15, 2021
Edited and reviewed by Marketing，R&D，QC
1. Purpose
The Specification is intended to provide the agreed specification and analysis frequency for Ectoin（Fermentation Method）.
2. References
Internal standard of Hubei Magic Health Technology Co., Ltd.
3. Responsibility
the specification revised by QA R&D
the analysis method revised by QC
4. Material Information
Formulations | Code | Packaging size |
Ectoin（Fermentation Method） | 100g/ bag | |
500g/ bag |
5. Requirements
5.1 Organoleptic
Item | Specification | Frequency |
Color | White powder | batch |
State | powder, without solid caking, no visible foreign matte | batch |
5.2 Physical and Chemical Specification
Item | Specification | Frequency |
Identification | The retention time of the major peak of the Sample solution corresponds to that of the Standard solution. | batch |
The IR spectrum of the sample is consistent with the standard spectrum. | batch | |
| Smell | Negative | batch |
Assay | ≧98.0 | batch |
| pH (2% aqueous solution) | 6.0-8.0 | batch |
Specific rotation | +139º-+141º | batch |
Chloride | ≤ 0.05% | batch |
Sulfate | ≤ 0.1% | batch |
Loss on drying | <0.5% | batch |
Moisture conten | <0.5% | batch |
Residue on ignition | ≤0.1% | batch |
Related substance | hydroxyectoine: ≤ 5.0% | batch |
Heavy metal residuals | Arsenic: ≤ 2.0 μg/g | batch |
| Cadmium: ≤ 5.0 μg/g | batch | |
| Lead: ≤ 10.0 μg/g | batch | |
Mercury: ≤ 1.0 μg/g | batch | |
| Nickel：≤ 10.0 μg/g | batch | |
Antimony：≤ 1.0 μg/ | batch | |
Residual solvent | Ethanol: ≤ 1000 ppm | batch |
5.3 Microbiological
Item | Specification | Frequency |
Total Plate Count, CFU/g | ≤100 | Statement |
Escherichia coli | Negative | Statement |
Yeasts and Molds, CFU/g | ≤100 | Statement |
Salmonell | Negative | Statement |
Staphylococcus aureus | Negative | Statement |
5.4 Others
Item | Specification | Frequency |
Non GMO-DNA | Correspond | Statement |
Non Allergen | Correspond | Statement |
Non Irradiation | Correspond | Statement |
5.5 Type Test
Shall provide at least one 3rd party test report per year according to the latest Standards.
6. Nutrient contents
Item | Per 100g | （NRV）% |
Energy (kJ) | 0 | 0 |
Fat (g) | 0 | 0 |
Carbohydrate (g) | 0 | 0 |
| Protein (g) | 0 | 0 |
Sodium (mg) | 0 | 0 |
Dietary Fiber (g) | 0 | 0 |
7. Packaging, Shelf Life and Freshness, Shipping Requirement and Storage
7.1 Packaging
7.1.1 Packaging size
The packaging size should meet standard or customers’ requirements.
7.1.2 Packaging Material
Packing materials should meet GB 9685. Inter package should be tightly closed and sealed while exterior package should avoid contamination. Label should meet GB 7718, GB29924 and GB/T 191.
7.1.3 Packing material
Inner Packing: Aluminum Foil bag, Outer Packing: Carton
Inner packaging: polyethylene bag, outer packaging: aluminum plastic composite bag, carton / paper barrel
7.2 Shelf Life and Freshness
7.2.1 Shelf Life
The shelf life should not be less than 24 months with an unbroken seal, storing under described condition.
7.2.2 Storage
Store in cool and dry area impervious to light. Avoid storing with toxic and hazardous material.
