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Omega-3: Ingredients and 
Stability Monitoring 
Dr. Steve Li, MD, M.Sc. (Clin. Pharm) 
Director of Laboratory Operations
Outline 
1. Omega-3 and its Product Development 
2. Quality Control and Issues with Omega-3 
Product Testing 
3. Stability Study 
www.diteba.com
What is omega-3? 
www.diteba.com
Omega-3 fatty acids 
They are polyunsaturated fatty acids 
α-linolenic acid (18:3, n-3; ALA), eicosapentaenoic acid (20:5, n-3; EPA), and 
docosahexaenoic acid (22:6, n-3; DHA) 
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Essential fatty acids 
ω-3 fatty acids: 
– α-Linolenic acid or ALA (18:3n-3) 
• ω-6 fatty acids: 
– Linoleic acid or LA (18:2n-6) 
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Fatty acid 
synthesis in the 
human body 
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Why do we need it? 
www.diteba.com
Omega-3 FA and our health 
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Omega-3 products 
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Common omega-3 dosage forms 
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The common active ingredients added in 
omega-3 
1. Minerals 
• Calcium 
• Selenium 
• Chromiun 
• Zinc 
2. Vitamins 
• Vitamin D 
• Vitamin A 
• Coenzyme Q10 
www.diteba.com 
3. Antioxidants 
• Vitamin E (alpha and 
gamma tocopherols) 
• Vitamin C and 
derivatives (Ascobyl 
palmatate) 
4. Others (Antibiotics, 
Hormones or Biologics)
Formulated products 
www.diteba.com
New product development 
• Applications (Enteral, Parenteral and Topical) 
• Taste and Appearance 
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• Bioavailability 
•Multiple health benefits 
• Stability
Omega-3 products 
www.diteba.com 
Eggs Yogurts Nutrition 
Drinks 
Meats 
Cheese 
Medicinal 
Formulas 
Bread Cosmetics
Now let’s see if we really do quality 
control for the products 
www.diteba.com
3 QbD things useful for omega-3-like 
products 
1. Can a product be easily tested? 
a) Is there a reliable method or compendial method 
for testing a product? 
b) Has a method been verified for a product? 
2. Is the formulation compatible? 
3. Is a product stable in storage? 
www.diteba.com
Challenges of quality control methods for 
testing omega-3 products 
• Oil Based Matrix---- Solubility and 
Homogeneity 
• Continuous Oxidation Process----Stability 
• Complexity of Formulation----Interfering 
Additives or 
Ingredients for testing 
• Less Specific----Less Supportive. 
www.diteba.com
Test methods for omega-3 fatty acids 
• Fatty Acid Oxidation 
• Release Testing of API and Products 
• Microbiological Tests 
• Heavy Metal Tests 
• Pesticides Tests 
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Oxidation is the main degradation 
pathway of omega-3 
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Oxidation Heat & Light 
Degradation
Omega-3 fatty acid oxidation tests 
• Acid Value: Titration method, 
www.diteba.com 
colorimetric 
• p-Anisidine Value: UV 350 nm 
• True Anisidine Value: HPLC UV 
• Peroxide Value: Titration method, 
colorimetric
Acceptable limits for oxidative stability 
parameters in marine oils 
www.diteba.com 
(Recommended Reporting Threshold) 
________________________________________ 
Acid Value NMT 3 mg KOH/Kg 
Peroxide value (PV) NMT 5 mEq/Kg 
Anisidine value (AV) NMT 20 
TOTOX value NMT 26 (2 x PV + AV ) 
True Anisidine Value TAVTM 70% of Anisidine Remaining 
______________________________________________________
Acid Value Test 
Titration Process and Color Change 
Steve Lianghong Li, NDI ADRL dba Diteba
Peroxide value test 
Titration Process and Color Change 
www.diteba.com
P-Anisidine value test 
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p-Anisidine HPLC-UV method 
0.005 
0.004 
0.003 
0.002 
0.001 
1.00 2.00 3.00 4.00 5.00 6.00 7.00 8.00 9.00 10.00 
www.diteba.com 
Typical Chromatogram of QL 
(S/N=15, 3.162 μg/mL) 
3.305 
p-Anisidine - 4.855 
Channel @ W2996 PDA 254.0 nm at 1.2 
AU 
0.000 
Minutes
Quantitative assay method for omega-3 
• Most common method is GC-FID or GC-MS 
• LCMS can be an good alternative. 
www.diteba.com
Stability Studies 
www.diteba.com
Unique features of omega-3 containing 
products and stability testing 
• Most of them are softgel capsules, oil liquid or oil 
based suspension 
• Most common degradation is oxidation and the 
degradation impurities are mixtures of multiple 
compounds. 
• It is extremely difficult to have a stability indicating 
method for Omega-3 fatty acids since the degradation 
products are variable and difficult to be easily identified 
and quantified using simply analytical methods. 
• Most of current methods for testing oxidation products 
are not specific and directly quantitative for the 
degradation products. 
www.diteba.com
Challenges in quality control and stability 
study of omega-3 products 
• Oil Based Matrix-Homogeneity 
• Unstable Due to Continuous Oxidation Process 
• Need More Efficient and Specific QC Analytical 
Methods 
• Formulated Product with Interfering Additives 
or Ingredients for the Current Test Methods 
www.diteba.com
General storage conditions in stability 
studies 
• Storage ICH 
Walk-in and Reach-in Chambers 
• Storage Conditions 
25°C/60% RH 
30°C/65% RH 
40°C/75% RH 
Photostability 
www.diteba.com
Specifications in stability study 
• Stability studies should include testing of those attributes of 
the API that are susceptible to change during storage and 
are likely to influence quality, safety and/or efficacy. 
• The testing should cover, as appropriate, the physical, 
chemical, biological and microbiological attributes. A guide 
as to the potential attributes to be tested in the stability 
studies. 
• Validated stability-indicating analytical procedures should 
be applied. 
• Whether and to what extent replication should be 
performed will depend on the results from validation 
studies 
www.diteba.com
Stability and testing frequency 
• For APIs with a proposed re-test period or shelf-life of at 
least 12 months, the frequency of testing at the long-term 
storage condition should normally be every three months 
over the first year, every six months over the second year, 
and annually thereafter throughout the proposed re-test 
period or shelf-life. 
• At the accelerated storage condition , a minimum of three 
time points, including 0, 3, and 6 month. 
• When testing at the intermediate storage condition a 
minimum of four time points, including the initial and final 
time points (e.g. 0, 6, 9 and 12 months), from a 12-month 
study is recommended. 
www.diteba.com
Typical example of stability program 
www.diteba.com
Typical stability program 
www.diteba.com
Compatibility studies (3 month) 
Formula 1 
% LC Oxidation 
Total EPA+DHA CoQ 10 
Time 
(Month) 
Time 
(Month) 
www.diteba.com 
p-Anisidine 
Value 
TAV 
(%) 
Peroxide 
Value 
(mEq/Kg) 
Acid 
Value 
(mg 
KOH/g) 
% Total 
Impurities 
0 98.5 102 120 85 6 1 1.00 
3 96.8 96 160 76 10 1.8 1.52 
Formula 5 
% LC Oxidation 
Total EPA+DHA 96Micro Extract A 
p-Anisidine 
Value 
TAV 
(%) 
Peroxide 
Value 
(mEq/Kg) 
Acid 
Value 
(mg 
KOH/g) 
% Total 
Impurities 
0 98.5 94 12 85 4 0.5 2.50 
3 96.8 72 160 76 10 1.8 8.00
Example of stability summary 
www.diteba.com 
% LC 
Month Batch 1 Batch 2 
0 98.5 98.5 
3 96.8 96 
6 94.7 94 
9 93.3 92.5 
12 92.3 86 
18 92.9 80 
24 91.6 76 
36 90.3 75
Fancy term but common logic 
Quality by Design (QbD) 
1. Analytical Methods 
2. Compatibility Study (3 Month) 
3. Specifications 
www.diteba.com
QbD principles 
www.diteba.com 
Desired 
State of 
Product 
ICH Q8- 
Pharm.Dev 
elopment 
ICH Q10 
Quality 
System 
ICH Q9-Quality 
Risk 
Management
Fate of drug product and philosophy 
• Only Very Small % Drug Products Get FDA Approval 
Product 
Philosophy 
Fate of 
Product 
Application 
Confirmation 
www.diteba.com 
Formula 
Quality 
Control 
Tox 
Product 
Philosophy 
Fate of 
Product 
Formula 
QbD 
Quality 
Control 
Application 
Confirmation 
Tox
Thank you! 
www.diteba.com 
Dr. Steve Li, MD, M.Sc. (Clin. Pharm) 
Director of Laboratory Operations 
stevel@diteba.com 
Connect with Diteba 
www.diteba.com

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Omega 3 additional ingredients and stability monitoring

  • 1. Omega-3: Ingredients and Stability Monitoring Dr. Steve Li, MD, M.Sc. (Clin. Pharm) Director of Laboratory Operations
  • 2. Outline 1. Omega-3 and its Product Development 2. Quality Control and Issues with Omega-3 Product Testing 3. Stability Study www.diteba.com
  • 3. What is omega-3? www.diteba.com
  • 4. Omega-3 fatty acids They are polyunsaturated fatty acids α-linolenic acid (18:3, n-3; ALA), eicosapentaenoic acid (20:5, n-3; EPA), and docosahexaenoic acid (22:6, n-3; DHA) www.diteba.com
  • 5. Essential fatty acids ω-3 fatty acids: – α-Linolenic acid or ALA (18:3n-3) • ω-6 fatty acids: – Linoleic acid or LA (18:2n-6) www.diteba.com
  • 6. Fatty acid synthesis in the human body www.diteba.com
  • 7. Why do we need it? www.diteba.com
  • 8. Omega-3 FA and our health www.diteba.com
  • 10. Common omega-3 dosage forms www.diteba.com
  • 11. The common active ingredients added in omega-3 1. Minerals • Calcium • Selenium • Chromiun • Zinc 2. Vitamins • Vitamin D • Vitamin A • Coenzyme Q10 www.diteba.com 3. Antioxidants • Vitamin E (alpha and gamma tocopherols) • Vitamin C and derivatives (Ascobyl palmatate) 4. Others (Antibiotics, Hormones or Biologics)
  • 13. New product development • Applications (Enteral, Parenteral and Topical) • Taste and Appearance www.diteba.com • Bioavailability •Multiple health benefits • Stability
  • 14. Omega-3 products www.diteba.com Eggs Yogurts Nutrition Drinks Meats Cheese Medicinal Formulas Bread Cosmetics
  • 15. Now let’s see if we really do quality control for the products www.diteba.com
  • 16. 3 QbD things useful for omega-3-like products 1. Can a product be easily tested? a) Is there a reliable method or compendial method for testing a product? b) Has a method been verified for a product? 2. Is the formulation compatible? 3. Is a product stable in storage? www.diteba.com
  • 17. Challenges of quality control methods for testing omega-3 products • Oil Based Matrix---- Solubility and Homogeneity • Continuous Oxidation Process----Stability • Complexity of Formulation----Interfering Additives or Ingredients for testing • Less Specific----Less Supportive. www.diteba.com
  • 18. Test methods for omega-3 fatty acids • Fatty Acid Oxidation • Release Testing of API and Products • Microbiological Tests • Heavy Metal Tests • Pesticides Tests www.diteba.com
  • 19. Oxidation is the main degradation pathway of omega-3 www.diteba.com Oxidation Heat & Light Degradation
  • 20. Omega-3 fatty acid oxidation tests • Acid Value: Titration method, www.diteba.com colorimetric • p-Anisidine Value: UV 350 nm • True Anisidine Value: HPLC UV • Peroxide Value: Titration method, colorimetric
  • 21. Acceptable limits for oxidative stability parameters in marine oils www.diteba.com (Recommended Reporting Threshold) ________________________________________ Acid Value NMT 3 mg KOH/Kg Peroxide value (PV) NMT 5 mEq/Kg Anisidine value (AV) NMT 20 TOTOX value NMT 26 (2 x PV + AV ) True Anisidine Value TAVTM 70% of Anisidine Remaining ______________________________________________________
  • 22. Acid Value Test Titration Process and Color Change Steve Lianghong Li, NDI ADRL dba Diteba
  • 23. Peroxide value test Titration Process and Color Change www.diteba.com
  • 24. P-Anisidine value test www.diteba.com
  • 25. p-Anisidine HPLC-UV method 0.005 0.004 0.003 0.002 0.001 1.00 2.00 3.00 4.00 5.00 6.00 7.00 8.00 9.00 10.00 www.diteba.com Typical Chromatogram of QL (S/N=15, 3.162 μg/mL) 3.305 p-Anisidine - 4.855 Channel @ W2996 PDA 254.0 nm at 1.2 AU 0.000 Minutes
  • 26. Quantitative assay method for omega-3 • Most common method is GC-FID or GC-MS • LCMS can be an good alternative. www.diteba.com
  • 28. Unique features of omega-3 containing products and stability testing • Most of them are softgel capsules, oil liquid or oil based suspension • Most common degradation is oxidation and the degradation impurities are mixtures of multiple compounds. • It is extremely difficult to have a stability indicating method for Omega-3 fatty acids since the degradation products are variable and difficult to be easily identified and quantified using simply analytical methods. • Most of current methods for testing oxidation products are not specific and directly quantitative for the degradation products. www.diteba.com
  • 29. Challenges in quality control and stability study of omega-3 products • Oil Based Matrix-Homogeneity • Unstable Due to Continuous Oxidation Process • Need More Efficient and Specific QC Analytical Methods • Formulated Product with Interfering Additives or Ingredients for the Current Test Methods www.diteba.com
  • 30. General storage conditions in stability studies • Storage ICH Walk-in and Reach-in Chambers • Storage Conditions 25°C/60% RH 30°C/65% RH 40°C/75% RH Photostability www.diteba.com
  • 31. Specifications in stability study • Stability studies should include testing of those attributes of the API that are susceptible to change during storage and are likely to influence quality, safety and/or efficacy. • The testing should cover, as appropriate, the physical, chemical, biological and microbiological attributes. A guide as to the potential attributes to be tested in the stability studies. • Validated stability-indicating analytical procedures should be applied. • Whether and to what extent replication should be performed will depend on the results from validation studies www.diteba.com
  • 32. Stability and testing frequency • For APIs with a proposed re-test period or shelf-life of at least 12 months, the frequency of testing at the long-term storage condition should normally be every three months over the first year, every six months over the second year, and annually thereafter throughout the proposed re-test period or shelf-life. • At the accelerated storage condition , a minimum of three time points, including 0, 3, and 6 month. • When testing at the intermediate storage condition a minimum of four time points, including the initial and final time points (e.g. 0, 6, 9 and 12 months), from a 12-month study is recommended. www.diteba.com
  • 33. Typical example of stability program www.diteba.com
  • 34. Typical stability program www.diteba.com
  • 35. Compatibility studies (3 month) Formula 1 % LC Oxidation Total EPA+DHA CoQ 10 Time (Month) Time (Month) www.diteba.com p-Anisidine Value TAV (%) Peroxide Value (mEq/Kg) Acid Value (mg KOH/g) % Total Impurities 0 98.5 102 120 85 6 1 1.00 3 96.8 96 160 76 10 1.8 1.52 Formula 5 % LC Oxidation Total EPA+DHA 96Micro Extract A p-Anisidine Value TAV (%) Peroxide Value (mEq/Kg) Acid Value (mg KOH/g) % Total Impurities 0 98.5 94 12 85 4 0.5 2.50 3 96.8 72 160 76 10 1.8 8.00
  • 36. Example of stability summary www.diteba.com % LC Month Batch 1 Batch 2 0 98.5 98.5 3 96.8 96 6 94.7 94 9 93.3 92.5 12 92.3 86 18 92.9 80 24 91.6 76 36 90.3 75
  • 37. Fancy term but common logic Quality by Design (QbD) 1. Analytical Methods 2. Compatibility Study (3 Month) 3. Specifications www.diteba.com
  • 38. QbD principles www.diteba.com Desired State of Product ICH Q8- Pharm.Dev elopment ICH Q10 Quality System ICH Q9-Quality Risk Management
  • 39. Fate of drug product and philosophy • Only Very Small % Drug Products Get FDA Approval Product Philosophy Fate of Product Application Confirmation www.diteba.com Formula Quality Control Tox Product Philosophy Fate of Product Formula QbD Quality Control Application Confirmation Tox
  • 40. Thank you! www.diteba.com Dr. Steve Li, MD, M.Sc. (Clin. Pharm) Director of Laboratory Operations stevel@diteba.com Connect with Diteba www.diteba.com