• Title/Summary/Keyword: USP(United Standard Pharmacopoeia)

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Studies on the Adiministration of Botanical Products's Quality in USA (미국에서의 Botanical Products(한약) 품질관리에 관한 연구)

  • Seong, Hyun-Jea;Choi, Sun-Mi;Yoon, Yoo-Sik
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.13 no.2
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    • pp.182-187
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    • 2000
  • Current status and quality administration of botanical products in America which has one of the biggest market need to be analyzed for the internationalization of oriental medicine. In this study, current status of botanical products as dietary supplements was analyzed and quality adminstration by United States Pharmacopoeia and National Formulary(USP-NF) was compared with The Korea Pharmacopoeia and botanical drug standard collection(KP), Even though the number of botanical products in USP-NF is small, it is rapidly increasing and more detailed compared with KP. Especially, reference standard compound should be determined for each botanical drugs, and more detailed standard for other items should be established in KP considering international trends. Though the history of botanical drugs in America is short, its annual market is about 3.2 billion dollar, so American administration system should be examined carefully for the internationalization of oriental medicine and related industry.

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Investigation on Adhesion Control Standards and Skin Adverse Effects of Skin Attached Formulations (파스제의 점착력 관리기준 및 피부 부작용 조사연구)

  • Kim, Ji Yeon;Kim, Kwang Joon;Park, Sang-Wook;Bang, Joon Seok;Lee, Wonjae
    • Korean Journal of Clinical Pharmacy
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    • v.24 no.3
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    • pp.219-228
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    • 2014
  • Objectives: This paper was aimed to investigate the adhesion control standards of pain relieving patch (PRP) drugs and to survey it's adverse effects on the skin of patients for safe use of PRP drugs. Methods: In this study, the related documents of PRP drugs of Korea pharmacopoeia (KP), United States pharmacopoeia (USP), Japanese Pharmacopoeia (JP), European pharmacopoeia (EP), and information web sites of the Ministry of Food and Drug Safety (MFDS) were surveyed. Also, the past and current labeling of PRP drugs marketed in the pharmacy was investigated and compared. Results: In KP and JP, the lower limit standard for PRP's adhesion control is established, but the upper limit standard is not designated. In USP and EP, neither the lower nor upper limit standard is established. The main reasons of skin adverse effects are considered as inherent adverse reactions of the applied drugs for PRP. Another reason is involved in patient's medication mistakes related to PRP's adhesion control, respiratory depression of skin according to physical skin closure, and microbial growth, etc. Conclusion: For safe use of PRP drugs, we proposed ensured guidelines like additional instructions of pharmacist's prescription and detailed labeling systems for usage of PRP drugs applied on skin.

A study on the synthesis of amorphous aluminium phosphate powders by hydrothermal precipitation method (수열침전법에 의한 비정질 인산알루미늄 분말의 합성에 관한 연구)

  • 김판채;최종건;황완인;이충효
    • Journal of the Korean Crystal Growth and Crystal Technology
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    • v.11 no.5
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    • pp.185-189
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    • 2001
  • Amorphous aluminium phosphate powders were synthesized as a single phase by neutralization reaction of a stoichiometric mixture of $Al_2(SO_4)_3$ and $H_3PO_4$ using the NaOH or KOH solution and subsequently by the hydrothermal precipitation method. The synthesis conditions were as follows : starting materials; $Al_2(SO_4)_3$ and $H_3PO_4$,pH ranges of neutralization reaction; between 5.6 and 6.0, temperature ranges of hydrothermal reaction; between 170 and $180^{\circ}C$,time ranges of hydrothermal reaction; between 4 and 5hs. Under such synthesis conditions, the products are obtained as amorphous aluminium phosphate powders of 0.1~0.3$\mu\textrm{m}$ in size and are Eitted to USP (United Standard Pharmacopoeia) test.

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Determination of triflusal in raw material and capsules by HPLC

  • Pham, Thuy-Vy;Mai, Xuan-Lan;Lee, Ji-Hyeon;Lee, Jong-Ha;Jo, Hyeon-Ah;Kang, Jong-Seong;Woo, Mi Hee;Na, Dong-Hee;Chun, In-Koo;Kim, Kyeong Ho
    • Analytical Science and Technology
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    • v.31 no.4
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    • pp.143-148
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    • 2018
  • Currently, the Korean Pharmacopoeia (KP XI) recommends HPLC and potentiometric titration (which is less specific than HPLC) for the determination of triflusal content in capsules and raw materials, respectively. Additionally, the British Pharmacopoeia (BP 2017) and European Pharmacopoeia (EP 8.0), which include a monograph for triflusal in raw materials only, describe a titration method for the assay. The latest version of the United States Pharmacopoeia (USP 39) and Japanese Pharmacopoeia (JP 17) still have not published monographs for triflusal and its preparations. To improve the specificity and efficacy of the assay, we present an HPLC method to determine triflusal content in both raw materials and capsules. The proposed method was validated in accordance with the requirements of the International Conference on Harmonization. A good linear relationship was achieved for triflusal in the range of $200-1250{\mu}g/mL$ with a coefficient of determination of approximately 0.9996. The relative standard deviations (RSDs) of inter- and intraday precision were 0.73-1.12 % and 0.34-0.51 %, respectively. The recovery percentage of triflusal was in the range of 98.80-101.31 %. Because its system suitability, intermediate precision, and robustness were satisfactory, this method could be suitable for determining triflusal content in raw materials and capsules.

A Comparison of Analytical Methods for the Content and Purity of Cefradine

  • Hyun, Myung-Ho;Jeong, Euh-Duck;Shin, Min-Seob;Jin, Jong-Sung
    • Bulletin of the Korean Chemical Society
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    • v.29 no.6
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    • pp.1185-1189
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    • 2008
  • Two HPLC methods such as cefadroxil and cefalexin methods were compared in their performance for the quantitative analysis of the content and purity of $\beta$ -lactamic antibiotic, cefradine, for six bulk drug samples. Between the two methods, the cefadroxil method prescribed by the European Pharmacopoeia (EP) for the determination of impurities in cefradoxil was superior to the cefalexin method prescribed by the EP and by the United States Pharmacopeia (USP) for the determination of cefalexin impurity in cefradine in terms of the greater stability of the chromatogram baselines and the higher precision, i.e., the lower % relative standard deviation (RSD). Based on the comparison of the two HPLC methods, the cefadroxil method was recommended to replace the TLC method, which has been prescribed by the EP as the official method for determination of extraneous impurities in cefradine.

Survey of Pharmacy Practice for Compounding Parenteral Nutrition in Hospital Setting - 2009 (병원약국 대상으로 정맥영양제 조제 실행에 관한 연구-2009)

  • Sin, Hye-Yeon;Jung, Ki-Hwa
    • YAKHAK HOEJI
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    • v.54 no.4
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    • pp.244-251
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    • 2010
  • Standardized parenteral nutrition is required to improve patient's safety, clinical appropriateness and to increase uniformity between institution and institutions. We assessed the consistency with the American society for parenteral and enteral nutrition (A.S.P.E.N.) practice guideline for PN by evaluating current practice process for parenteral nutrition formulation in inpatients pharmacies in Korea. Each question in this survey was based on 2007 A.S.P.E.N. recommendations of standard parenteral nutrition formulation, the American society of health-system pharmacists (ASHP), and the United State Pharmacopoeia (USP) Chapter 797 guideline for compounding parenteral nutritions. All 90 Korean society of hospital pharmacist (KSHP) member directors of pharmacy were requested to respond to the survey in order to compare the survey results to ASHP national survey of pharmacy practice in hospital settings (2002) in compliance with A.S.P.E.N. guideline. We had final response rate of 35.6%. 25 (100%) hospitals complied with this Garb guideline (response rate was 84.4%) which was the highest compliance. Only 17.9% of hospital pharmacies were actively involved in complications monitoring. Monitoring complications and efficacy were least in compliance with the A.S.P.E.N. guideline. 69.0% of Korean pharmacists adjusted medication dosage based on disease state or monitoring laboratory data in compliance with the A.S.P.E.N. guideline. Over 50% of the hospital pharmacies failed to provide and evaluate staff training in aseptic manipulation skills periodically. Korean hospital pharmacies need to comply with the standard practice guideline for compounding sterile preparation in order to provide better quality of parenteral nutrition service for specific patient population.