Q10 Rule in Shelf Life Studies (2024)

Q10 Rule in Shelf Life Studies (1)

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Aditya Bhardwaj Q10 Rule in Shelf Life Studies (2)

Aditya Bhardwaj

Senior Manager Quality at ARKRAY Healthcare Pvt Ltd.

Published Sep 12, 2019

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Shelf life studies are used to determine how long a product can reasonably be expected to maintain its quality, safety, and character. These studies take into account not only products’ functional qualities such as safety and effectiveness, but also cosmetic qualities such as color and texture that make them appealing to customers. An acceptable shelf life for a product is one that allows its desired end of shelf life parameters (EOSLs) to be maintained; these include a product’s sensory, chemical, functional, microbiological, and physical properties. Since the EOSLs are different for every product, the test procedure for conducting a shelf life study will be unique for each product.

A tool used in accelerated studies is “the rule of ten,” or Q10, which is the factor by which the rate of spoil-age increases when the temperature is raised by 10C. Q10 allows for the prediction of a product’s shelf life under real-life conditions based on the results of testing conducted at high temperatures. It is unitless and can be calculated with the equation Q10 = (R2/R1)(10/(T2-T1)), where R is the time it takes for a product to spoil and T is the temperature at which the testing is conducted. For most products the Q10 value is 2.0, which means that for every increase of 10C, the rate of a chemical reaction will double. In an example, a product was tested at three different temperatures to obtain the time to spoilage. Q10 values were obtained by comparing T2/T1 with R2/R1 and T3/T2 with R3/R2.

Q10 Rule in Shelf Life Studies (3)

Applying these numbers to the equation:

Q10 Rule in Shelf Life Studies (4)

The actual Q10 for this product is approximately 1.6, not the value of 2.0 that is generally assumed. If this product started to spoil after eight weeks, to determine the shelf life at 20C the time to spoilage would be multiplied by the Q10 value twice, once for each 10C change in temperature. When calculating the shelf life of this product using a Q10 value of 2.0, the predicted shelf life is 32 weeks (8 months), but with a Q10 value of 1.6 the predicted shelf life is 20.48 weeks (5.2 months).

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Dr. Hitesh Chauhan

Biologist, Nanotechnology, Materials Science, Physicist, IVD, Medical Device

1y

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Prakash RANA

Rapid Diagnostic Test Design, QC, QA, Regulatory compliance and Production

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Reference?

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AiYing Ch'ng

Laboratory Operations Manager at ALS Technichem (M) Sdn Bhd

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I would like to ask for clarification, R is the rate or R is the time. As if it is referring to Time, it is unlikely that time to spoil is increasing when Temperature is increased.

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Q10 Rule in Shelf Life Studies (2024)

FAQs

What is the Q10 rule in shelf life studies? ›

A tool used in accelerated studies is “the rule of ten,” or Q10, which is the factor by which the rate of spoil-age increases when the temperature is raised by 10C. Q10 allows for the prediction of a product's shelf life under real-life conditions based on the results of testing conducted at high temperatures.

What is the Q10 rule and why is it important? ›

The Q10 coefficient (James, 1953, Blehrádek, Hegarty) has been widely described in the literature as a measure of the degree of temperature dependence of a given chemical or biological process. It is usually defined as the rate ratio of a given process taking place at temperatures differing by 10 units (℃ or K).

What is Q10 in stability studies? ›

Q10 –The Q10 is a constant. It is an ageing factor for 10°C increase or decrease in temperature. The value is determined through testing of materials at a variety of temperatures and is generally considered outside the scope of the development of accelerated test protocols.

What does Q10 value mean? ›

The Q10 is expressed as the ratio of the velocity of a chemical reaction at a given temperature to that of the same reaction at a temperature 10 °C lower. From: Q10 (temperature coefficient) in The Oxford Dictionary of Sports Science & Medicine »

What is the Q10 value for accelerated aging? ›

Ambient Temperature (TRT) Aging Factor (Q10): The aging factor is typically between 1.8 - 2.5 with a value of 2.0 being the most common value.

What are the Ich Q10 guidelines? ›

ICH Q10 is a crucial quality management standard for pharmaceutical companies. ICH Q10 was developed by the International Council on Harmonization (ICH) to provide a comprehensive framework for the modern pharmaceutical quality management system.

What is the meaning of Q10? ›

A nutrient that the body needs in small amounts to function and stay healthy. Q10 helps mitochondria (small structures in the cell) make energy. It is an antioxidant that helps prevent cell damage caused by free radicals (highly reactive chemicals).

Does Q10 expire? ›

Most supplements that are maintained properly (unopened, out of excessive heat and light) should be fine for at least 2 years. However, since it may take you a few months to use up the pills in your CoQ10 bottle, it would seem best for you to return it and ask for a more recently-manufactured product.

What is the Q10 method? ›

The Q 10 method is another well-known predictive technique. It assumes that the ratio of the times to equivalent damage at two temperatures, usually 10°C apart, has a constant value. The Q 10 method is not very accurate in practice. And, contrary to popular belief, it does not obey the Arrhenius equation.

What is the Q rule accelerated stability? ›

The Q rule states that a product degradation rate decreases by a constant factor Q10 when the storage temperature is decreased by 10°C. The value of Q10 is typically set at 2, 3 or 4 because these correspond to reasonable activation energies.

What is the Q10 rule in microbiology? ›

Biological reactions usually exhibit Q10 values ranging from 2 to 3 [6]. As a rule of thumb, for every 10 °C rise in temperature, the reaction rates will double, resulting in an expected Q10 value of 2.

What is the 10 degree rule for accelerated aging? ›

The rule that the polymer thermal aging rate k is doubled for every ∆T = 10 °C temperature increase from a reference temperature T1, the 10°C rule eq. (1), is widely used in the literature and on the internet. For instance, in medical device R&D it is used as a quick guideline for polymer screening.

Why is Q10 relevant to enzyme-controlled reactions? ›

If the reaction rate increases with increasing temperature, Q10 is greater than 1. For most mesophilic enzymes, Q10=2–3 [11]. This shows that the rate of the reaction doubles or triples with every 10 K rise in temperature. The more temperature-dependent a process is, the higher is its Q10 value.

What is the range of most biological Q10 data? ›

Q10 varies between 2 and 3 in biological systems [2], and Q10 = 2 is applied in modelling the rate of metabolic heat production in relation to body temperature [3,4].

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