ERUDITIO Vol.
No.
Juni 2025 ERUDITIO Vol.
No.
JUNE 2025, pp.
P-ISSN: 2580-7722 | E-ISSN: 2807-6222
P-ISSN: 2580-7722 | E-ISSN: 2807-6222
Stability Study for Determining the Shelf Life of Glucosamine Hydrochloride Laboratory Reference Standard Neni Isnaeni a,1 The Indonesian Food and Drug Authority.
Jl.
Percetakan Negara No.
Central Jakarta 10560.
Indonesia isnaeni@pom.
*corresponding author
ARTICLE
INFO
Article history Received:
February 25.
Revised:
August 7, 2025 Accepted:
Augustu 22, 2025 DOI:
https://doi.
org/10.
54384/eruditio.
i2/205 ABSTRACT / ABSTRAK Reference standards are essential in drug and food control to ensure the quality and validity of test results.
According to ISO 17034:2016, the Center for National Quality Control Laboratory of Drugs and Food .
OMN), as a producer of reference materials, must evaluate and monitor the stability of the standards it produces.
Stability testing is critical to maintain product quality during storage and use.
However, pOMN-developed reference standards had not undergone stability testing to determine shelf life.
This study therefore conducted a stability assessment of the Glucosamine hydrochloride reference standard to ensure stability during transportation, distribution, and storage.
Long-term stability tests were conducted at 4Ae8AC at 0 months .
, 72 months, and 144 months.
Short-term stability tests were performed at 25AC and 60AC for 72, 120, 168, and 240 hours, with 0 hours as the control.
Stability analysis was performed using validated High-Performance Liquid Chromatography (HPLC), and analyte stability was assessed using a t-test.
Results indicated that the Glucosamine hydrochloride secondary reference standard remained stable under recommended storage conditions for 144 months and at distribution temperatures up to 60AC for 240 hours .
-count = 0.
These findings demonstrate that the reference standard maintains its quality under specified conditions, ensuring the reliability and validity of pharmaceutical testing.
The study concludes that the glucosamine hydrochloride reference standard has guaranteed quality and can be used as long as it is stored under the recommended conditions and shelf life.
Information regarding storage conditions and shelf life can be included on the reference standard label.
Baku pembanding sangat penting dalam pengawasan obat dan makanan untuk menjamin kualitas dan validitas hasil pengujian.
Sesuai dengan ISO 17034:2016, pOMN sebagai produsen bahan acuan harus mengevaluasi dan memonitor stabilitas baku pembanding sekunder yang diproduksi.
Uji stabilitas merupakan langkah krusial untuk memastikan bahwa kualitas produk tetap terjaga selama penyimpanan dan penggunaan.
Namun, baku pembanding yang dikembangkan oleh pOMN belum dilakukan uji stabilitas untuk menentukan masa simpan baku pembanding tersebut.
Oleh karena itu, pada penelitian ini dilakukan studi stabilitas baku pembanding glukosamin hidroklorida untuk memastikan kestabilannya selama proses transportasi, distribusi, dan penyimpanan.
Studi stabilitas jangka panjang dilakukan pada suhu penyimpanan 4-8AC pada 0 bulan sebagai kontrol dan selama 72 dan 144 bulan, studi stabilitas jangka pendek dilakukan pada suhu 25AC dan 60AC pada 0 jam dan selama 72, 120, 168, dan 240 jam.
Metode analisis stabilitas dengan KCKT yang tervalidasi.
Stabilitas analit dianalisis dengan uji t.
Hasil analisis menunjukkan baku pembanding glukosamin hidroklorida stabil pada suhu penyimpanan yang direkomendasikan selama 144 bulan stabil selama distribusi dengan maksimal suhu 60AC selama 240 jam .
hitung = 0,.
Studi membuktikan Neni Isnaeni Neni Isnaeni Stability Study for Determining the Shelf Life of Glucosamine Hydrochloride Laboratory Reference Standard Stability Study for Determining the Shelf Life of Glucosamine Hydrochloride Laboratory Reference Standard ERUDITIO Vol.
No.
JUNE 2025, pp.
P-ISSN: 2580-7722 | E-ISSN: 2807-6222
ERUDITIO Vol.
No.
Juni 2025
P-ISSN: 2580-7722 | E-ISSN: 2807-6222
bahwa baku pembanding Glukosamin hidroklorida stabil pada kondisi penyimpanan Dengan demikian, kualitas dan validitas hasil pengujian sediaan farmasi yang menggunakan baku pembanding tersebut dapat terjamin.
Dari penelitian ini dapat disimpulkan bahwa baku pembanding Glukosamin hidroklorida memiliki kualitas yang terjamin dan dapat digunakan sepanjang disimpan pada kondisi penyimpanan dan umur simpan yang direkomendasikan.
Informasi terkait kondisi penyimpanan dan umur simpan dapat dicantumkan pada label baku pembanding Keywords: stability study.
Glucosamine hydrochloride, reference standard.
ISO 17034:2016 Kata Kunci: studi stabilitas.
Glukosamin hidroklorida, baku pembanding.
ISO 17034:2016 Introduction Reference standards are uniform and authentic materials used in the testing of physical and chemical properties, whose characteristics are compared with substances of high purity according to their intended use (WHO, 2.
Secondary reference standards are compounds whose characteristics are established through comparison with primary reference standards.
Primary reference standards are recognized as having appropriate quality within a specific context, where their values are accepted without comparison to other chemical substances.
The traceability of both must be well documented (WHO, 2.
Secondary reference standards must share the same properties as the relevant primary standards in relation to the designated tests.
The requirements for reference standards include clearly defined characteristics, stability, homogeneity, and appropriate labeling on the packaging or certificate of analysis that provides transparent information.
The values specified in pharmacopeial reference standards are considered valid for their intended use (ISO, 2009.
WHO, 2.
The development of reference standards is crucial for strengthening testing capacity and capability to enhance drug and food regulatory control in Indonesia.
Reference standards are used to ensure the quality and validity of drug and food testing.
The Reference Standard Laboratory at the Center for National Quality Control Laboratory of Drugs and Food .
OMN), as an ISO 17034-accredited producer of reference materials, is responsible for guaranteeing the quality of both Indonesian Pharmacopeia Reference Standards (BPFI) and Laboratory Reference Standards (BPL).
Quality assurance of reference standards is conducted through the evaluation and monitoring of the stability of the standards produced.
Stability testing is a key step in pharmaceutical product development to ensure that quality is maintained throughout storage and use.
According to the WHO, environmental factors such as temperature, humidity, and light, as well as product-related factors such as the chemical and physical properties of the active ingredients and excipients, dosage form and composition, manufacturing process, container-closure system, and packaging materials, can all affect the stability of pharmaceutical products (Ashutosh Kumar Yadav et , 2.
The primary purpose of long-term stability studies is to determine the shelf life of drug products.
The term "stability" refers to the length of time a dosage form remains within its specifications before degradation occurs.
The shelf life .
xpiry dat.
of a product is calculated based on this duration.
Stability testing aims to demonstrate how the quality of a drug substance changes over time (Ashutosh Kumar Yadav et al.
, 2.
Accordingly, this study carried out both long-term and short-term stability testing of the glucosamine Neni Isnaeni Neni Isnaeni Study Stability Study for DeterminingStability the Shelf LifeforofDetermining the Shelf Life of Glucosamine Hydrochloride Laboratory Reference Standard Glucosamine Hydrochloride Laboratory Reference Standard ERUDITIO Vol.
No.
Juni 2025
ERUDITIO
Vol.
No.
JUNE2807-6222
2025, pp.
P-ISSN:
| E-ISSN:
P-ISSN: 2580-7722 | E-ISSN: 2807-6222
hydrochloride reference standard to verify its stability during transportation, distribution, and storage.
The distinction between long-term stability and short-term stability lies primarily in the objectives, observation period, and storage conditions.
Long-term stability testing is used to establish expiry dates and recommended storage conditions, typically lasting from six months to several years, depending on the desired shelf life.
In contrast, short-term stability testing assesses the stability of a substance when short-term deviations from recommended storage conditions occur, for example, during distribution or temporary removal from storage.
The observation period generally ranges from one day to several weeks, depending on the deviation scenario (WHO, 2.
Glucosamine hydrochloride (CAS 66-84-.
, chemically named D-Glucose, 2-amino-2deoxy-, hydrochloride, is a white or nearly white crystalline powder with the chemical formula C6H13NO5AHCl and a molecular weight of 215.
63 g/mol (United States Pharmacopeia, 2.
Its chemical structure is presented in Figure 1.
Figure 1.
Chemical structure of glucosamine hydrochloride Glucosamine is an amino sugar naturally produced by the body and serves as a precursor in the biochemical synthesis of glycosylated proteins and lipids.
It is a component of polysaccharides, chitosan, and chitin, and is one of the most abundant monosaccharides.
Commercially, glucosamine is produced by hydrolyzing the exoskeletons of crustaceans (Nam Xuan Vo.
Ngan Nguyen Hoang Le.
Trinh Dang Phuong Chu & Khang Xuan An Dinh.
Uyen Thi Thuc Che.
Thanh Thi Thanh Ngo, 2.
Deficiency in glucosamine can lead to health issues, particularly in joints, increasing the risk of osteoarthritis.
Osteoarthritis is a degenerative disease caused by insufficient cartilage regeneration in joints, leading to stiffness, pain, and swelling.
Several studies suggest that glucosamine may aid in cartilage regeneration, reduce inflammation, and decrease collagen degradation, thus helping to treat osteoarthritis, although its exact mechanism remains unclear.
Glucosamine is most commonly available in supplement form and is widely used as a dietary supplement to promote joint health and manage osteoarthritis.
Several studies have reported methods for analyzing glucosamine hydrochloride using infrared spectrophotometry and high-performance liquid chromatography (HPLC) (AlbertoSilva et al.
, 2020.
Asthana et al.
, 2019.
Choezom et al.
, 2.
However, no studies have reported stability testing of pOMN-produced glucosamine hydrochloride secondary reference standard for shelf-life determination.
Therefore, this study conducted stability testing of the glucosamine hydrochloride reference standard to ensure that its quality remains intact during storage and use.
The material was characterized using infrared spectrophotometry and HPLC, followed by method validation and stability testing using HPLC.
Validation parameters included selectivity, accuracy, linearity, range, detection, and quantification limits, as well as precision .
epeatability and intermediate precisio.
Neni Isnaeni Neni
Isnaeni Stability Study for Determining the Shelf Life of Glucosamine Hydrochloride Reference