Armaceutical dextrose monohydrate (DMH) as one of the raw materials for drugs which is widely used in the manufacture of infusions and drug preparations, including BBO, which is entirely still imported. To achieve the independence of national pharmaceutical raw materials, it is important to study and develop the DMH pharmaceutical production process technology in Indonesia. In this research, the validation of the DMH pharmaceutical production process using food quality liquid glucose raw materials on a pilot-scale of 5 - 6 kg/product was carried out. The validation process has been carried out three times in all stages of the process, namely saccharification, carbon purification, resin purification, evaporation, crystallization, centrifugation, and drying. Several test parameters have been established at each stage of the process so that the repeatability of the production process and the quality of pharmaceutical DMH can be achieved. The results showed that each stage of the process played a role in improving the quality of dextrose. Product yield and weight loss of dextrose in the whole process were 50–52% and 9–10%, respectively. The results of testing the levels of dextrose (dextrose equivalent/DE), endotoxin content, pyrogen-free tests, and other parameters that have been carried out on pharmaceutical DMH products have met the quality requirements according to the Indonesian Pharmacopoeia Edition V. In conclusion, the validation results show that the bench-scale pharmaceutical DMH production process technology is developed to produce pharmaceutical DMH products with process repeatability and good quality. Abstrak Dekstrosa Monohidrat (DMH) farmasi merupakan bahan baku obat (BBO) yang banyak digunakan pada pembuatan infus dan sediaan obat serta termasuk salah satu BBO yang seluruhnya masih dimpor. Untuk mencapai kemandirian bahan baku farmasi nasional, maka pengkajian dan pengembangan teknologi proses produksi DMH farmasi menjadi penting untuk dilakukan di Indonesia. Dalam penelitian ini telah dilakukan validasi proses produksi DMH farmasi menggunakan bahan baku glukosa cair kualitas pangan pada skala pilot 5–6 kg produk/bets. Proses validasi telah dilakukan sebanyak tiga kali ulangan pada seluruh tahapan proses yaitu sakarifikasi, pemurnian dengan karbon, pemurnian dengan resin, evaporasi, kristalisasi, sentrifugasi, dan pengeringan. Beberapa parameter uji telah ditetapkan pada setiap tahapan proses agar keterulangan proses produksi dan kualitas DMH farmasi dapat tercapai. Hasil penelitian menunjukkan bahwa setiap tahapan proses berperan dalam peningkatan kualitas dekstrosa. Rendemen produk dan kehilangan berat dekstrosa pada keseluruhan proses masing-masing adalah 50–52% dan 9–10%. Hasil pengujian kadar dekstrosa (dekstrosa ekivalen/DE), kandungan endotoksin, uji bebas pirogen, dan parameter lain yang telah dilakukan terhadap produk DMH farmasi adalah sudah memenuhi persyaratan kualitas sesuai Farmakope Indonesia Edisi VI. Disimpulkan, hasil validasi menunjukkan bahwa teknologi proses produksi DMH farmasi skala pilot yang dikembangkan dapat menghasilkan produk DMH farmasi dengan keterulangan proses dan kualitas yang baik.

Validasi proses kristalisasi telah dilakukan untuk produksi Dekstrosa Monohidrat (DMH) kualitas mikrobiologi yang mempunyai kemurnian tinggi secara sistem batch pada skala bench kapasitas 3 - 4 kg produk. DMH tersebut banyak digunakan sebagai bahan kimia di laboratorium dan industri khususnya  di bidang mikrobiologi, bioteknologi dan biofarmasi. Penelitian ini bertujuan untuk memvalidasi proses kristalisasi DMH kualitas mikrobiologi secara sistem batch. Validasi proses yang dilakukan adalah meliputi tahapan pelarutan bahan baku, kristalisasi, sentrifugasi dan pengeringan serta analisis produk. Dalam penelitian ini, proses kristalisasi dilakukan dengan parameter profil penurunan suhu secara linier, penambahan seed sebanyak 0,5% , kecepatan pengadukan 50 rpm dan waktu kristalisasi 72 jam. Hasil validasi proses produksi DMH kualitas mikrobiologi telah dilakukan sebanyak 3 kali ulangan dengan yield masing-masing adalah 54,62%, 55,66% dan 56,85%. Parameter kualitas produk ditunjukkan oleh kemurnian DMH (HPLC Area %) masing-masing adalah 99,53%, 99,61% dan 99,15 % serta parameter lainnya yang sudah memenuhi persyaratan sesuai standar produk yang ada di pasar.

The CuO-nanoleaf/g-Al2O3 catalyst was synthesized through wet chemical impregnation and had promising catalytic activity in reducing p-Nitrophenol (PNP) into p-Aminophenol (PAP). The synthesis was conducted in situ with Ethylene Glycol as a stabilizer agent of the CuO-nanoleaf structure and g-Al2O3 as catalyst support with high adsorption ability. Furthermore, the crystal phase, morphology, element composition, and specific surface area were investigated by X-Ray Diffraction (XRD), Field Emission Scanning Electron Microscopy (FESEM), and N2 adsorption-desorption, respectively. The XRD pattern showed the crystal phase of CuO and g-Al2O3 in the composite, and the morphology was successfully reported using FESEM. The increase in the specific surface area of the catalyst indicates that the CuO material was well composited in g-Al2O3. The catalyst has good activity in reducing PNP to PAP with 93.53% PNP conversion within 4 min. In addition, the reduction reaction of PNP with excess NaBH4 could be categorized as pseudo-first order kinetic with a constant rate of 0.6935 min−1 for CuO-nanoleaf/g-Al2O3 catalyst. The loading catalyst and temperature reaction effect on PNP conversion were also investigated. The results showed that 94.18% PNP conversion was obtained within only 2.5 min under the optimized conditions. Copyright © 2022 by Authors, Published by BCREC Group. This is an open access article under the CC BY-SA License (https://creativecommons.org/licenses/by-sa/4.0).