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ORMEGA Stability Study Protocol

This document outlines a stability study protocol for ORMEGA capsules to establish an expiration date under real time storage conditions. Tests will evaluate appearance, weight, disintegration time, moisture content, oxidation, contaminants, nutrient levels, and microbiological quality over 36 months of storage at 25°C and 60% relative humidity. Two batches manufactured in October 2015 and January 2014 will be tested at regular intervals to verify product quality through the proposed expiration dates.

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Ferdian Iwank Iriyanto
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56 views2 pages

ORMEGA Stability Study Protocol

This document outlines a stability study protocol for ORMEGA capsules to establish an expiration date under real time storage conditions. Tests will evaluate appearance, weight, disintegration time, moisture content, oxidation, contaminants, nutrient levels, and microbiological quality over 36 months of storage at 25°C and 60% relative humidity. Two batches manufactured in October 2015 and January 2014 will be tested at regular intervals to verify product quality through the proposed expiration dates.

Uploaded by

Ferdian Iwank Iriyanto
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

STABILITY STUDY 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 specification

Tests Specification
Appearance Clear oblong 22 softgel containing yellow oil with a
characteristic odor
Filling weight 1,080 – 1,320 mg/softgel
Uniformity of weight Individual weight of the capsule to be within 90-110% of
the averge weight of 1,524.55mg/softgel
Disintegration time < 30 minutes
Shell moisture content 6 – 10%
Peroxide value NMT 5.0mEq/kg
Dioxin ad Furans NMT 2 pg WHO-PCDD/F-TEQ/g fat
Dioxin- Like PCBs NMT 3 pg WHO-PCDD/F-TEQ/g fat
PCBs NMT 0.045 mg/Kg
EPA NLT 540mg / softgel
DHA NLT 270mg / softgel
Arsenic NMT 5 ppm
Cdmium NMT 0.3 ppm
Lead NMT 10 ppm
Mercury NMT 0.5 ppm
Total aerobic count < 2 X 104 cfu/g
Total combined yeast & mold count < 2 X 102 cfu/g
Escherichia coli Absent in 1 g
Salmonella spp Absent in 10 g
Staphylococcus aureus Absent in 1 g
Pseudomonas aeruginosa Absent in 1g
Bile-tolerant gram- negative bacteria < 100 cfu/ g
5. Storage condition
Real time study: 25 ± 2 oC, RH 60 ± 5%

6. Study design

No. Batch No. Mfg date Exp date Type of Study


1 R21510082 Oct 14, 2015 Oct 14, 2018 Real time
2 R21401055 Jan 20, 2014 Jan 20, 2017 Real time

7. Expected duration
Real time study : 36 months
Sampling interval (months) : 0, 3, 6, 9, 12, 158, 24 & 36

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