Regulatory reference: | USP85. |
Claim: | Absence of bacterial endotoxins |
Application field: | Medical devices: raw ingredients and finished products. |
Description of the test: | Lysate of limulus amaebocytes (LAL) is an acqueous extract obtained by Limulus polyphemus amaebocytes. The LAL reacts strongly to endotoxins in Gram-negative bacterial membranes (lypopolysacchartides), resulting in coagulation. This property is exploited in the LAL test to detect endotoxins. |
Regulatory reference: | According to OECD 456. |
Claim: | No endocrine disruption |
Application field: | Raw ingredients and finished products. |
Description of the test: | The purpose of the test is identifying substances that interfere with 17-ß estradiol and testosterone production. |
Regulatory reference: | Proprietary method |
Claim: | Improves cicatrization |
Application field: | Wound healing products. |
Description of the test: | Analysis of the regenerative efficacy on epidermal cell cultures after simulated wounding. Results in terms of percentage of improvement in the regeneration kinetics versus untreated substrate. |
Regulatory reference: | Proprietary method |
Claim: | Mucoadhesive effect |
Application field: | Finished products for direct application on external mucosae. |
Description of the test: | Gravimetric analysis of the adhesion of a product on a layer of mucin against the same product on an untreated plane. Detachment kinetics in terms of percentage of adhesion against a non-adhesive control. |
Regulatory reference: | Proprietary method |
Claim: | Resistance to washing off by saliva |
Application field: | Finished products for oral application. |
Description of the test: | Analysis of the resistance to washing off by artificial saliva by gravimetric analysis of the dry weight of the sample before and after washes in controlled conditions. |
Regulatory reference: | Guidelines to Commission Regulation (EU) No 655/2013 |
Claim: | Dermatologically tested |
Application field: | Heating and cooling medical devices and cosmetic products. |
Description of the test: |
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