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Identifikasi Batas Besi pada Asam Amino Tirosin dan Lisin Asetat di Departemen Research and Development PT. Ethica Industri Farmasi) = Identification of Iron Limits in Amino Acids Tyrosine and Lysine Acetate at the Research and Development Department of PT. Ethica Industri Farmasi

Amira Hasna Chalid; Donna Maretta Ariestanti, supervisor (Fakultas Farmasi Universitas Indonesia, 2023)

 Abstract

Industri farmasi bertanggung jawab untuk memastikan produksi obat yang aman, berkualitas, dan efektif. Salah satu tantangan utama adalah deteksi dan pengelolaan cemaran, termasuk cemaran besi, yang dapat memengaruhi keamanan dan kualitas produk farmasi. Penelitian ini bertujuan untuk mengidentifikasi kadar cemaran besi dalam asam amino tirosin dan lisin asetat yang digunakan dalam industri farmasi. Proses analisis melibatkan pengujian kekeruhan dan penentuan kadar besi sesuai standar farmakope. Hasil menunjukkan bahwa larutan uji tirosin dan lisin asetat tidak melebihi kekeruhan larutan pembanding. Selain itu, kadar besi pada kedua larutan memenuhi batas yang ditetapkan dalam monografi. Temuan ini menunjukkan bahwa tirosin dan lisin asetat yang diuji aman untuk digunakan dalam formulasi farmasi. Identifikasi cemaran secara rutin menjadi langkah penting untuk memastikan keamanan, efikasi, dan mutu produk farmasi.

The pharmaceutical industry is responsible for ensuring the production of safe, high-quality, and effective drugs. One of the primary challenges is the detection and management of impurities, including iron impurities, which can impact the safety and quality of pharmaceutical products. This study aims to identify the iron impurity levels in tyrosine and lysine acetate amino acids used in the pharmaceutical industry. The analysis process involved turbidity testing and iron content determination in accordance with pharmacopeial standards. The results indicated that the test solutions of tyrosine and lysine acetate did not exceed the turbidity of the reference solution. Furthermore, the iron levels in both solutions met the limits specified in the monograph. These findings demonstrate that the tested tyrosine and lysine acetate are safe for use in pharmaceutical formulations. Routine impurity identification is an essential step in ensuring the safety, efficacy, and quality of pharmaceutical products.

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 Metadata

Collection Type : UI - Tugas Akhir
Call Number : PR-pdf
Main entry-Personal name :
Additional entry-Personal name :
Additional entry-Corporate name :
Study Program :
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Publishing : Depok: Fakultas Farmasi Universitas Indonesia, 2023
Record of Work Profesi
Cataloguing Source LibUI ind rda
Content Type text
Media Type computer
Carrier Type online resource
Physical Description xii, 31 pages : illustration + appendix
Concise Text
Holding Institution Universitas Indonesia
Location Perpustakaan UI
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Call Number Barcode Number Availability
PR-pdf 16-25-42592881 TERSEDIA
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No review available for this collection: 9999920566597
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