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GB/T 38093-2019: Determination of the high-molecular polymers in β-lactam antibiotics - Gel chromatography
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 38093-2019 | English | 119 |
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Determination of the high-molecular polymers in β-lactam antibiotics - Gel chromatography
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GB/T 38093-2019
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Basic data | Standard ID | GB/T 38093-2019 (GB/T38093-2019) | | Description (Translated English) | Determination of the high-molecular polymers in ��-lactam antibiotics - Gel chromatography | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | A21 | | Classification of International Standard | 07.080 | | Word Count Estimation | 6,639 | | Date of Issue | 2019-10-18 | | Date of Implementation | 2019-10-18 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 38093-2019: Determination of the high-molecular polymers in β-lactam antibiotics - Gel chromatography
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Determination of the high-molecular polymers in β-lactam antibiotics--Gel chromatography
ICS 07.080
A21
National Standards of People's Republic of China
Determination of β-lactam antibiotic polymer
Gel chromatography
Published on.2019-10-17
2019-10-18 implementation
State market supervision and administration
China National Standardization Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard was proposed and managed by the China National Institute of Standardization.
This standard was drafted. China Metrology University, China National Institute of Standardization, Beijing Sambo Technology Co., Ltd.
The main drafters of this standard. Xu Yipeng, Ye Hong, Yu Xiaoping, Ma Aijin, Shen Tu Xuping, Zhang Yafen, Cui Haifeng, Hao Shuai.
Determination of β-lactam antibiotic polymer
Gel chromatography
1 Scope
This standard specifies a method for the determination of high molecular weight polymers in β-lactam antibiotics by gel chromatography.
This standard applies to penicillin V potassium, ceftriaxone, cefotaxime, cefradine, cefuroxime, cefoperazone, cefazolin, cefotaxime
Determination of endogenous high molecular weight polymers in the development and production of 10 kinds of β-lactam antibiotics such as oxazole, oxacillin and procaine hydrochloride.
The detection limit of this method is 0.08 μg.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 6682 Analytical laboratory water specifications and test methods
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Endogenoushigh-molecularpolymers
A type of high molecular substance obtained by polymerizing a β-lactam antibiotic molecule itself.
4 Principle
According to the relative molecular mass, the β-lactam antibiotics and their high molecular polymers are classified by high performance gel column.
The measurement was carried out at 254 nm by a UV detector, and the peak retention time was used to determine the peak area.
5 reagents or materials
Analytically pure reagents are used unless otherwise specified.
5.1 Water. GB/T 6682, first grade water.
5.2 Acetonitrile (CH3CN). HPLC grade.
5.3 5mmol/L phosphate buffer, pH7.0.
Accurately weigh 0.432g of disodium hydrogen phosphate and 0.312g of sodium dihydrogen phosphate dihydrate, dissolve in 950mL of water, adjust the pH to
7.0, add water to a volume of 1L, 0.22μm pore size filter.
5.4 β-lactam antibiotics. purity ≥ 98%.
6 instruments
6.1 High Performance Liquid Chromatograph. equipped with a UV detector.
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