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Stability Study Protocol Ormega

This document outlines a stability study protocol for VTVA Pharmaceutical Inc.'s ORMEGA capsule. The protocol describes testing the capsules under real-time and accelerated storage conditions over 36 and 6 months, respectively, to establish an expiration date. Tests will evaluate appearance, weight uniformity, disintegration time, moisture content, oxidation levels, contaminants, microbes, and vitamin E levels according to defined specifications over multiple sampling intervals. The storage conditions are 30±2°C at 75±5% RH for real-time and 40±2°C at 75±5% RH for accelerated studies. Four batches will be included in the two study types.

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Ferdian Iwank Iriyanto
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90 views

Stability Study Protocol Ormega

This document outlines a stability study protocol for VTVA Pharmaceutical Inc.'s ORMEGA capsule. The protocol describes testing the capsules under real-time and accelerated storage conditions over 36 and 6 months, respectively, to establish an expiration date. Tests will evaluate appearance, weight uniformity, disintegration time, moisture content, oxidation levels, contaminants, microbes, and vitamin E levels according to defined specifications over multiple sampling intervals. The storage conditions are 30±2°C at 75±5% RH for real-time and 40±2°C at 75±5% RH for accelerated studies. Four batches will be included in the two study types.

Uploaded by

Ferdian Iwank Iriyanto
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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\ VTVA Pharmaceutical Inc.

r38E0 \'IKNG PLACE, RICE\IO:$D, B.C. \'6\'lKt TEL: (5(X) 7r&0Er6 FAX: (60,1) 718-0817
\Ycbsltc: n'rr.rtvrobrrm.com e-mell: [email protected]

STABILITY STTIDY PROTOCOL

1. Purpose
To document the process to be used for establishing expiration date under real time
condition for dietary supplement

2. General information
Name of product ORMEGA
Dosage form Capsule

3. Container
Bottle : HDPE Plastic bottle
Closure : Air tight cover from plastic with desiccant

4. Item test and specifrcation

Tests Specifrcation Sample quantity


Appearance Clear oblong 22 softgel containing yellow 10's
oil with a characteristic odor
Filling weight 1,080 - 1,320 mg/softgel 20's
Uniformity of weight Individual weight of the capsule to be 20's
within 90-l l0% of the average weight of
l,524.Slmglsoftgel
Disintegration time <30 minutes 6',s
Shell moisture content 6-10% 5',s
Peroxide value NMT 5.OmEq/kg l0's
Dioxin ad Furans NMT 2 pg WHO-PCDD/F-TEQ/g fat 5's
Dioxin- Like PCBs NMT 3 pg WHO-PCDD/F-TEQ/g fat 5's
PCBs NMT 0.045 mg/Kg 5's
EPA NLT 540mg / softgel 20's
DHA NLT 270mg / softgel 20's
Arsenic NMT 0.1 ppm 5's
Cadmium NMT 0.1 ppm 5',s
Lead NMT 0.1 ppm 5',s

Mercury NMT 0.1 ppm 5',s


Total aerobic count < 2X lOa cfu/g 20's
Total combined yeast & < 2X lO2cfir/g 20's
mold count
Escherichia coli Absent in Ig 5',s
Salmonella spp Absent in l0 g 5',s

Staphylococcus aureus Absent in I g 5',s


VVO vwA Pharmaceutical Inc.
r3AO VIKnIG PLACE, RICE\IOND, B-C. 1'6\' IKt Tf,,L: (5ltd) 7l&ml5 FAX: (604) 7lt{tr7
\}'ebslte: wrn'.rtrohrrm.com c-mdt lnf@ r'trrpLrrm-com
Pseudomonas aeruginosa Absent in 1g 5',s
Bile-tolerant gram- < 100cfir/g 5',s
negative bacteria
Vitamin E < 500 ppm (HPLC) 1',s

5. Storage condition
Real time study: 30 +2 0C, RH 75 * 50/o
Accelerabd study: 40 +2 0c, RH 75 + 5%

6. Studvdesiqn

No. BatchNo. Mfg date Exp date Type ofStudy


I Real time
2 Real time
J Accelerated
4 Accelerated

7. Exoected duration
Real time study :36months
Sampling interval (months) : 0,3, 6, 9, 12, 18, 24 & 36

Accelerated study : 6 months


Sampling interval (months) : 0,3 &6

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