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Stability Real Time Report

VTVA Pharmaceutical Inc. conducted a real-time stability study on their Omega-3 softgel product ORMEGA. Batches NP15100E2 and R21401055 were tested initially and at 3, 6, 9, 12, 18, 24, and 36 months for appearance, weight variation, disintegration time, peroxide value, heavy metals, microbiological limits, and vitamin E content. All parameters remained within specifications throughout the testing period. The chief scientific officer approved the batches as stable for 36 months when stored at 30°C ± 2°C/75% ± 5% RH.
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0% found this document useful (0 votes)
147 views2 pages

Stability Real Time Report

VTVA Pharmaceutical Inc. conducted a real-time stability study on their Omega-3 softgel product ORMEGA. Batches NP15100E2 and R21401055 were tested initially and at 3, 6, 9, 12, 18, 24, and 36 months for appearance, weight variation, disintegration time, peroxide value, heavy metals, microbiological limits, and vitamin E content. All parameters remained within specifications throughout the testing period. The chief scientific officer approved the batches as stable for 36 months when stored at 30°C ± 2°C/75% ± 5% RH.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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138t0

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:

Xie...Chief Scientific Officer

/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:

Approved By Xie...Chief Scientific Officer Sign

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