GB/T 38093-2019 English PDF

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GB/T 38093-2019: Determination of the high-molecular polymers in β-lactam antibiotics - Gel chromatography
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 38093-2019	119	Add to Cart	3 days	Determination of the high-molecular polymers in β-lactam antibiotics - Gel chromatography	Valid

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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

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
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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