Selection and strategy of water determination methods in pharmaceuticals

ZHOU Hao; WANG Huijie; ZHAO Yuanyuan; WANG Huan; ZHANG Shibo

doi:10.11665/j.issn.1000-5048.20220117

Journal of China Pharmaceutical University > 2022 > 53(1): 113-119. > DOI: 10.11665/j.issn.1000-5048.20220117

ZHOU Hao, WANG Huijie, ZHAO Yuanyuan, WANG Huan, ZHANG Shibo. Selection and strategy of water determination methods in pharmaceuticals[J]. Journal of China Pharmaceutical University, 2022, 53(1): 113-119. DOI: 10.11665/j.issn.1000-5048.20220117

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Selection and strategy of water determination methods in pharmaceuticals

Chia Tai Tianqing Pharmaceutical Co., Ltd., Nanjing 211100, China

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Received Date: June 07, 2021
Revised Date: January 06, 2022

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Abstract

Abstract

Water content determination is an important aspect of quality research in the whole process of pharmaceutical development, production, storage and use.Therefore, it is significant to develop an accurate and robust method for the determination of water content in the quality control of pharmaceuticals.In this article, the selection and strategy for the study of water determination methods are explained on the basis of general water determination principles and application examples in Chinese and foreign pharmacopoeias, together with the analysis of sample structure, solubility and water content.This article aims to provide basis for the development of moisture testing methods and formulation of proper quality standards for pharmaceuticals.
- water determination methods,
- drug,
- sample structure,
- solubility,
- water content

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References (23)

References

[1]	. Beijing：China Medical Science Press，2019.
[2]	Zhu BF，Chen YH，Zhang GM，et al. Water removal methods and application in drug synthesis［J］. Chin J Pharm（中国医药工业杂志），2020，51（4）：37-47.
[3]	Bao XJ，Chen X，Wang SR，et al. Coamorphous combinations of poorly water-soluble drugs dabigatran etexilate mesylate and tadalafil for improving dissolution and physical stability［J］. J China Pharm Univ（中国药科大学学报），2019，50（5）：549-559.
[4]	European Pharmacopoeia Commission. European Pharmacopoeia10.0［S］. Strasbourg：European Directorate for Quality Medicines，2019.
[5]	Chinese Pharmacopoeia Commission. Chinese Pharmacopoeia：part 2（中华人民共和国药典：二部）［S］. Beijing：China Medical Science Press，2020.
[6]	Chinese Pharmacopoeia Commission. Chinese Pharmacopoeia：part 4（中华人民共和国药典：四部）［S］. Beijing：China Medical Science Press，2020：114-115.
[7]	The United States Pharmacopeial Convention. United States Pharmacopoeia2021：General Chapter < 921> Water Determination ［S/OL］. （2013-05-01）［2021-10-08］. https：//online.uspnf.com/uspnf/document/1_GUID-FBA763E7-E62C-4F19-A3E0-2141FD4EFFE4_1_en-US.htm.
[8]	Pharmaceuticals and Medical Devices Agency of Japan. The Japanese Pharmacopoeia 17［S］. Tokyo：The Ministry of Health，Labor and Welfare，2016.
[9]	Wang C，Xu MZ，Wang LX，et al. Several Karl Fischer water determination methods［J］. Chin J Pharm Anal（药物分析杂志），2008，28（12）：2145-2148.
[10]	Liang GL，Li J，Quan QL. Improvement of the moisture determination of vidarabine monophosphate［J］. West China J Pharm Sci（华西药学杂志），2019，34（3）：193-195.
[11]	Yin QS，Ren CL，Yu M，et al. Water determination in doxorubicin hydrochloride implants by dissolution and transfer method［J］. Anhui Med Pharm J（安徽医药），2018，22（2）：232-234.
[12]	Hao QH. Uncertainty evaluation for water determination of cefi xime tablets by Fischer''s method［J］. World Notes Antibiot（国外医药（抗生素分册）），2017，38（4）：193-195，199.
[13]	Fu CW，Hong W，Qin HL，et al. Comparison of two methods for determination of antibiotic moisture［J］. Chin J Mod Appl Pharm（中国现代应用药学），2019，36（17）：2166-2170.
[14]	Chen QL，Lei XP，Feng Y. Comparison of different methods for the moisture determination in prostaglandil for injection［J］. Shanghai Med Pharm J（上海医药），2019，40（7）：71-73.
[15]	Zhang CY，Zhao H，Ning BM. Study on the determination of water content in folic acid［J］. Drug Stand China（中国药品标准），2019，20（5）：433-436.
[16]	The United States Pharmacopeial Convention. United States Pharmacopoeia2021：glimepiride［S/OL］.（2020-05-01）［2021-10-08］. https：//online.uspnf.com/uspnf/document/1_GUID-2CA981F2-7751-4B53-B682-1B63DE8FB129_4_en-US.htm.
[17]	The United States Pharmacopeial Convention. United States Pharmacopoeia2021：orbifloxacin tablets ［S/OL］. （2021-05-01）［2021-10-08］. https：//online.uspnf.com/uspnf/document/1_GUID-2A56DBA4-4AF5-4F67-9E00-36C47914AA37_1_en-US.htm.
[18]	The United States Pharmacopeial Convention. United States Pharmacopoeia2021：magnesium gluconate ［S/OL］. （2021-05-01）［2021-10-08］. https：//online.uspnf.com/uspnf/document/1_GUID-F9A68B23-DE69-4638-8C47-E44C042249FF_3_en-US.htm.
[19]	The United States Pharmacopeial Convention. United States Pharmacopoeia 2021：rosiglitazone maleate［S/OL］. （2020-05-01）［2021-10-08］. https：//online.uspnf.com/uspnf/document/1_GUID-2FB091AC-3D96-4D10-8D47-762EE6F51DFC_4_en-US.htm.
[20]	Lindquist J. Determination of water in penicillins using fast Karl Fischer reagents and electronic end-point optimization［J］. J Pharm Biomed Anal，1984，2（1）：37-44.
[21]	Sherman F，Kuselman I. Water determination in drugs containing ascorbic acid［J］. Drug Dev Ind Pharm，1999，25（10）：1115-1119.
[22]	Cachet T，Hoogmartens J. The determination of water in erythromycin by Karl Fischer titration［J］. J Pharm Biomed Anal，1988，6（5）：461-472.
[23]	Zhang QL，Yang YX，Luo YH，et al. Study on the correlation among hygroscopicity，solubility and specific surface area of the chemical reference［J］. Chin J Mod Appl Pharm（中国现代应用药学），2020，37（11）：1343-1349.

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[10]	PHARMACOKINETICS OF OCTANOYLPRIMAQUINE IN RABBITS[J]. Journal of China Pharmaceutical University, 1986, (2): 125-128.

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