 |
F9XB061
Bouliga
3913900090
Bouliga
230mda
25kg/bottle
| molecular weight: | |
|---|---|
The Cross linked hyaluronte powder add to purified water could got dermal filler
Test Items | Acceptance Criteria | Test Result |
1. Characters | powder or fibrous aggregate | Complied |
2. Identification | ||
A. Identification or IR spectrum | Corresponding to reference spectrum | Complied |
B. Uronic acid reaction | Purple and red color | Complied |
3. Clarity and color of solution | Clear;A600nm≤0.01 | Clear;A600nm:0.006 |
4. pH | 5.0～8.5 | 6.3 |
5. Particle size | D10-D90:100~1200μm, D50: Actual value | 445 μm |
6. Viscoelasticity | Actual value | Elastic modulus: 1101.0 Pa Viscous modulus: 311.8 Pa |
7. Loss on drying | ≤15.0% | 2.1 % |
8. Heavy metals | ≤10 ppm | <10 ppm |
9. Residue on lgnition | ≤18.0 % | 11.4 % |
10.Residual ethanol | ≤0.5 % | 0.3 % |
11.Residual BDDE | ≤50μg/g | Not detected |
12.Assay of Sodium Hyaluronate | 95.0 %~105.0% | 95.8 % |
13.Bacterial Endotoxins | <0.05 EU/mg | <0.05 EU/mg |
14.Total aerobic microbial count | ≤500 cfu/g | <20 cfu/g |
15. Total yeasts and molds count | ≤100 cfu/g | <20 cfu/g |
16. Staphylococcus aureus | Negative | Negative |
17.Escherichia coli | Negative | Negative |
18.Pseudomonas aeruginosa | Negative | Negative |
The Cross linked hyaluronte powder add to purified water could got dermal filler
Test Items | Acceptance Criteria | Test Result |
1. Characters | powder or fibrous aggregate | Complied |
2. Identification | ||
A. Identification or IR spectrum | Corresponding to reference spectrum | Complied |
B. Uronic acid reaction | Purple and red color | Complied |
3. Clarity and color of solution | Clear;A600nm≤0.01 | Clear;A600nm:0.006 |
4. pH | 5.0～8.5 | 6.3 |
5. Particle size | D10-D90:100~1200μm, D50: Actual value | 445 μm |
6. Viscoelasticity | Actual value | Elastic modulus: 1101.0 Pa Viscous modulus: 311.8 Pa |
7. Loss on drying | ≤15.0% | 2.1 % |
8. Heavy metals | ≤10 ppm | <10 ppm |
9. Residue on lgnition | ≤18.0 % | 11.4 % |
10.Residual ethanol | ≤0.5 % | 0.3 % |
11.Residual BDDE | ≤50μg/g | Not detected |
12.Assay of Sodium Hyaluronate | 95.0 %~105.0% | 95.8 % |
13.Bacterial Endotoxins | <0.05 EU/mg | <0.05 EU/mg |
14.Total aerobic microbial count | ≤500 cfu/g | <20 cfu/g |
15. Total yeasts and molds count | ≤100 cfu/g | <20 cfu/g |
16. Staphylococcus aureus | Negative | Negative |
17.Escherichia coli | Negative | Negative |
18.Pseudomonas aeruginosa | Negative | Negative |
