Omnia product specification & safety data

Omnia Drops product specification (SP-002; 18.11.2016) compliance is confirmed by following analytical parameters 

ANALYTICAL PARAMETERS

PARAMETER METHOD REQUIREMENTS RESULT
FORMULATION AND CHARACTERISTICS Organoleptic Texture Liquid Pass
Colour White Pass
Odor Characteristic Pass
Taste Characteristic (oleic acid) Pass
CONCENTRATION Acc. to supplier’s COA Chondroitin sulphate 25 mg/ml ±10% Pass
Oleic acid 12.5 mg/ml ±10% Pass
ACTIVITY Acc. to supplier’s COA Vitamin D2 100 IU/ml ±10% Pass
Vitamin D3 100 IU/ml ±10% Pass
ENDOTOXIN LEVEL LAL assay 0.5 EU/ml   Pass
STERILITY Trypone Soya Agar Total aerobic microbial count <10 to the power of 3 cfu/ml Pass
Sabouraud (+ dextrose + chloramfenikol) Total combined yeast and mold count <10 to the power of 2 cfu/ml Pass
McConkey Broth Absence of E.coli in 10g Pass
MYCOPLASMA NAT/PCR Negative   Pass
RETROVIRUSES PERT Negative   Pass
pH Potentiometry 5.7 -6.0 (t=20°C)   Pass