Stability Real Time Report
Stability Real Time Report
Vvo Webslte:
VTVA Pharmaceutical Inc.
VIKING PLACE, RICBIOND, B.C. V6\' IKB
trrm'.$v.phrl'm.com
TEL: (604) 7l&0t16 FN(: (604) 7rE{,817
e-mell: lnfo@r{vrph$'m.com
QUALITY CONTROL DEPARTMENT Type of packing : l4's, 30's & 63's/bottle White
STABILITY STUDY REPORT Storage condition: temperature 30o + 2"C
(Real-Time Stability test) Average humidity :75o/o+ 5% RH
Product Name: ORMEGA Batch No. nP15100E2 date: 2021 date: 2024
Date of test 08.06.2021 11.06.21 02.06.22 05.06.22 08.06.22 02.06.23 08.06.23 08.06.24
Duration (month) Initial 3 6 9 12 l8 24 36
Appearance: Clear oblong 22 softgel containing Conforms Conforms
yellow oil with a characteristic odor
Filline weisht variation: l200me/softeel + l0% 1203.6me 1207.5ms,
Uniformity of weight: Individual weight of the Conforms Conforms
capsule to be within 90-ll0o/o of the average weight
of 1.524.5Smc/softsel
Disintegration test: NMT 30 minutes Conforms Conforms
Shell moisture content: 6Yo to l0o/o 7.0o/o 7.5o/o
Peroxide Value: NMT 5.0mEq/ke 3.lmEO/Ke 3.2mEQ/Ke
Dioxins and Furans; NMT 2 pg WHO-PCDD/F. < l.opg < l.opg
TEQ/g fat WHo-TEQ/g WHO-TEQ/g
EPA: NLT 540mg / softgel 600.9mg 615.0mg
DHA: NLT 270mg / softgel 300.15mg 310.25mg
Arsenic: NMT 0.1 ppm <o.lPPm <0.lppm
Cadmium: NMT 0.1 ppm < 0.lppm < 0.lppm
Lead: NMT 0.1 ppm <0.lppm <0.1ppm
Mercury: NMT 0.1 ppm <0.lppm <0.lppm
Total Aerobic Count: < 2X lOa cf,r/g < lOcfrr/g < l0cfir/g
Total Combined Molds and Yeasts Count: < 2x 102 <1Octu/g <1 Ocfn/g
cft/g
Escherichia coli: Absent in I g Negative Negative
Salmonella spp: Absent in l0 g Negative Negative
Staphylococcus aureusi Absent in 1 g Negative Negative
Pseudomonas aeruginosa: Absent in lg Negative Negative ./-^ottli^ \
Bile-tolerant gram- negative bacteria: < 100cfu/ g <1OOctu/g <1OOcfu/g /^t$"L....1.I' u6\
Vitamin E: < 500 ppm 430ppm 425ppm I .r\-.''' '1..-_ \
Conclusion:
/Pcnna
r3tE0
\llvo VTW\ Pharmaceutical Inc.
l'IKIllG PLACE, RrcHilloND, B.c. \6v rK8
TEL: (6tt4) ?l&0816 FAx: (604) 7rE{tl7
Wcbslte: wnry.r{vrohilm.com e-mrll: lufo@rlvrphrrm.com
QUALITY CONTROL DEPARTMENT Type of packing : l4os, 30's & 63's/bottle White
STABILITY STUDY REPORT Storage condition; temperature 30o * 2oC
(Real-Time Stability test) Average humidity :75o/o* 5% RH
Product Name: ORMEGA Batch No. R21401055 date: Jr 2021 date: J 2024
Date of test 07.30.2021 10.30.2021 01.30,2022 04.30.2022 07.30.2022 01.30.2023 07.30.2023 07.30,2024
Duration month) Initial J 6 9 t2 l8 24 36
Appearancer Clear oblong 22 softgel containing Conforms Conforms
yellow oil with a characteristic odor
+ 0o/o 1202.9me 1201.6mc
Uniformity of weight: Individual weight of the Conforms Conforms
capsule to be within 90-ll0% of the average weight
of 1,524.55mg/softgel
Disintegrqtion test; NMT 30 minutes Conforms Conforms
Shell moisture content; 60/oto l0o/o 7.5o/o 7,20/o
v 3.2mEQ/Ke 3.3mEQ/Ke
Dioxins and Furans; NMT 2 pg WHO-PCDD/F- < l.opg < l.opg
fat WHO-TEQ/g WHO-TEQ/g
EPA: NLT 540mg / softgel 600.6mg 602.4mg
DHA: NLT / softgel 300.24mg 306.25mg
NMT 0.1 ppm <0.lppm <0.loom
-Aqrqqrc:
Cadmium: NMT 0,1 ppm < 0,lppm < 0.lppm
Lead: NMT 0.1 ppry <0.lppm <0,1ppm
_lt4qqCry: NMT 0.1 ppm <0,lnpm <0.lppm
Total Aerobic Count: < 2X l}a cfu/g < l0cfuig < lOcfir/g
Total Combined Molds and Yeasts Count: <2x 102 <10ctu/g <l0cfu/g
cfi.r/g
Escherichia coli: Absent in I g Negative Negative
Salmonella spp: Absent in l0 g Negative Negative
Staphylococcus ctureus; Absent in I g Negative Negative
Pseudomonas aeruginosa: Absent in lg Negative Negative .4.7
Bile-tolerant gram- negative bacteria: < 100cfu/ g <1O0ctu/g <1O0ctu/g
// {(QOvt'uul,e Zz\
Vitamin E: < 500 ppm 425ppm 432ppm / ^{o'.....- .-ra \
Conclusion: