Long-term stability test for lutein

I. Overview of Lutein

Lutein, also known as a "plant-based xanthophyll," is an oxygenated carotenoid found abundantly in natural plants such as marigolds, bananas, kiwis, and corn. As a highly effective antioxidant, it helps protect the human body against cellular and organ damage caused by oxygen free radicals, thereby aiding in the prevention of conditions associated with aging-such as cardiovascular hardening and coronary heart disease. Most importantly, lutein is the only carotenoid present in the crystalline lens of the eye; it serves as a primary pigment and antioxidant component within the macula of the retina. Since many ophthalmic diseases are closely linked to a deficiency in lutein, it plays a vital role in protecting the eyes.

II. Stability Testing Schedule

January 29, 2024 – January 28, 2026

III. Test Protocol

1. Sample Storage and Packaging

Taking into account the storage and usage conditions of lutein products, the samples used for this stability study are packaged and stored under the same conditions as those for commercial-scale production batches-specifically, at room temperature, protected from light, and in double-layer vacuum packaging.

Storage Location: Intermediate Product Warehouse

Storage Packaging: Simulated commercial packaging, consisting of an inner plastic vacuum bag and an outer aluminum foil bag.

2. Selection of Test Batches

For this stability study, three batches of 5% lutein samples have been selected. These samples were produced using the same processes as those employed in full-scale commercial production.

3. Testing Frequency

Starting from January 29, 2025, each batch will be sampled a total of 7 times, at the following intervals: 0 months, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.

4. Test Parameters

Based on the standards and characteristics of lutein, the parameters to be evaluated in this study include appearance, content (assay), and loss on drying. These indicators may change during the storage of lutein, potentially affecting its quality and efficacy.

IV. Sampling of Test Samples

The products used in this stability study were manufactured in the Lutein production facility. Following quality inspection and subsequent storage, samples for the stability study were collected in accordance with standard sampling procedures. The results obtained from testing and analysis were recorded and archived to serve as the basis for the evaluation of stability data.

V. Evaluation of Stability Data and Conclusions

The shelf life and storage conditions of the product are determined based on its appearance, assay (content), and loss on drying. The data from this study are presented in the form of tables and charts, enabling an effective assessment of the stability of the lutein.

1. The stability test data are as follows:

Table 1

Figure 1

Table 2

Figure 2

Table 3

Figure 3

2. Conclusions from Long-term Stability Studies

Long-term stability studies on three batches of lutein products show that after 24 months of observation and testing, the product's appearance did not change. The maximum degradation rate of the active content was 1.92%, and changes in loss on drying were minimal; both met the established requirements. It can therefore be concluded that the product exhibits good stability for 24 months under the specified storage conditions.

You can contact us directly or email donna.zh@kingsci.com to buy lutein powder, obtain further information, and request free samples.