Omnia Food Supplement – Analytical Parameters

Summary Report

BATCH NO: 2016/01

Version: final (audited)

PRODUCT NAME: Omnia Food Supplement

REPORT PREPARED BY: M. Sagan

REPORT VERIFIED BY: F. Jelen, PhD

DATE OF RELEASE: 21.11.16

1. Formulation and characteristics Formulation and characteristic parameters have been confirmed organoleptically.

2. Concentration

Omnia Drops contain 22.8 mg/ml of chondrotin sulphate ingredient. 

Omnia Drops contain ^—12.5 mg/ml of oleic acid. 

3. Activity

Omnia Drops contain 100 IU/m1 of vitamin D2. Certificate of analysis is attached to the report. Omnia Drops contain 1018 IU/ml of vitamin D3. 

4. Endotoxin level

Endotoxin level in Omnia Drops has been evaluated by Limulus Amebocyte Lysate (LAL) assay. 

5. Sterility

Total aerobic microbial count has been evaluated by inoculating Trypone Soya Agar with 100 p.1 of Omnia Drops and incubation at 37°C for 5 days. No colonies were observed.

Total combined yeast and mold count has been evaluated by inoculating Sabouraud (+ dextrose + chloramfenikol) with 100 [1.1 of Omnia Drops and incubation at 37°C for 5 days. No colonies were observed.

All experiments has been performed in triplicates.

Absence of E.coli in 10g has been confirmed by inoculating McConkey Broth with 10g of Omnia Drops and incubation at 37°C for 5 days. Turbidity was observed, therefore Coliform Agar plate was inoculated with broth sample. After 24 h no colonies were observed.

Reference: USP29-NF24 page 3087 http://www.pharmacopeia.cn/v29240/usp29nf24s0_c2023.html#usp29nf24s0_c2023 [18t^h November 2016]

6. Mycoplasma

Mycoplasma presence in Omnia Drops has been evaluated by NAT (Nucleic Acids Amplification Techniques). Result was negative. 

7. Retrovirus

Retrovirus presence in Omnia Drops has been evaluated by PERT (Product Enhanced Reverse Transcriptase assay). Result was negative. 

8. pH

pH of the VDTP solution was determined using Hanna Instruments HI2212 pH-meter. Measurement was repeated three (3) times and average value was calculated: