名稱：藥典二氧化碳（CO2）凈化裝置

型號：HHO-III Purification device

應(yīng)用：2020版及2015版中國藥典二氧化碳中碳?xì)浠衔餃y定  氣相色譜法

2020年版《中華人民共和國藥典》（以下簡稱《中國藥典》）已由國家藥品監(jiān)督管理局 國家衛(wèi)生健康委2020年第78號公告發(fā)布，自2020年12月30日起實(shí)施?，F(xiàn)就實(shí)施本版《中國藥典》有關(guān)事宜公告如下：

一、根據(jù)《藥品管理法》的規(guī)定，藥品應(yīng)當(dāng)符合國家藥品標(biāo)準(zhǔn)。《中國藥典》是國家藥品標(biāo)準(zhǔn)的重要組成部分，是藥品研制、生產(chǎn)（進(jìn)口）、經(jīng)營、使用和監(jiān)督管理等相關(guān)單位均應(yīng)遵循的法定技術(shù)標(biāo)準(zhǔn)。

二、《中國藥典》主要由凡例、品種正文和通用技術(shù)要求構(gòu)成。自實(shí)施之日起，所有生產(chǎn)上市藥品應(yīng)當(dāng)符合本版《中國藥典》相關(guān)技術(shù)要求。

三、自實(shí)施之日起，凡原收載于歷版藥典、局（部）頒標(biāo)準(zhǔn)的品種，本版《中國藥典》收載的，相應(yīng)歷版藥典、局（部）頒標(biāo)準(zhǔn)同時廢止；本版《中國藥典》未收載的，仍執(zhí)行相應(yīng)歷版藥典、局（部）頒標(biāo)準(zhǔn)，但應(yīng)符合本版《中國藥典》的相關(guān)通用技術(shù)要求，經(jīng)上市后評價撤銷或注銷的品種，相應(yīng)歷版藥典、局（部）頒標(biāo)準(zhǔn)廢止。

本版《中國藥典》品種正文未收載的制劑規(guī)格、中藥的制法，其質(zhì)量標(biāo)準(zhǔn)按本版《中國藥典》同品種相關(guān)要求執(zhí)行，規(guī)格項(xiàng)、制法項(xiàng)分別按原批準(zhǔn)證明文件執(zhí)行。

四、藥品注冊標(biāo)準(zhǔn)中收載檢驗(yàn)項(xiàng)目多于或者異于藥典規(guī)定的，或者質(zhì)量指標(biāo)嚴(yán)于藥典要求的，應(yīng)在執(zhí)行藥典要求的基礎(chǔ)上，同時執(zhí)行注冊標(biāo)準(zhǔn)的相應(yīng)項(xiàng)目和指標(biāo)。

藥品注冊標(biāo)準(zhǔn)收載檢驗(yàn)項(xiàng)目少于藥典規(guī)定或質(zhì)量指標(biāo)低于藥典要求的，應(yīng)執(zhí)行藥典規(guī)定。

浩瀚色譜（山東）應(yīng)用技術(shù)開發(fā)有限公司以振興民族企業(yè)為己任，根據(jù)2020中國藥典二氧化碳中規(guī)定的要求：碳?xì)浠衔锏暮坎淮笥?.0020%的指標(biāo)要求，升級改造了HHO-III Purification device凈化裝置，并命名為2021年NEW款，此款設(shè)備更加符合2020版藥典，凈化效果好，定量準(zhǔn)確。

浩瀚色譜，提供詳細(xì)的操作方法，提供安裝圖紙。

2020年版《中華人民共和國藥典》 測試譜圖：


The 2020 edition of the Pharmacopoeia of the People's Republic of China
The 2020 edition of "The Pharmacopoeia of the People's Republic of China" Details:

Name: Pharmacopoeia carbon dioxide (CO2) purification device

Model: HHO-III Purification device

Application: 2020 and 2015 Chinese Pharmacopoeia Determination of Hydrocarbons in Carbon Dioxide Gas Chromatography


The 2020 edition of the "Pharmacopoeia of the People's Republic of China" (hereinafter referred to as the "Chinese Pharmacopoeia") has been issued by the National Medical Products Administration and National Health Commission Announcement No. 78, 2020, and will be implemented on December 30, 2020. The relevant matters concerning the implementation of this edition of the Chinese Pharmacopoeia are hereby announced as follows:

1. According to the provisions of the "Drug Administration Law", drugs should comply with national drug standards. The "Chinese Pharmacopoeia" is an important part of the national drug standards, and is a legal technical standard that should be followed by relevant units such as drug research and development, production (import), operation, use, supervision and management.

2. The "Chinese Pharmacopoeia" mainly consists of legends, variety texts and general technical requirements. From the date of implementation, all drugs produced and marketed shall meet the relevant technical requirements of this edition of the Chinese Pharmacopoeia.

3. From the date of implementation, all varieties that were originally included in the pharmacopoeias of the calendar and the standards issued by the bureaus (ministries), and those included in this edition of the Chinese Pharmacopoeia, the corresponding pharmacopoeias and the standards issued by the bureaus (ministers) shall be abolished simultaneously; If this edition of the "Chinese Pharmacopoeia" is not included, the corresponding historical editions of the pharmacopoeia and bureau (ministerial) standards shall still be implemented, but should comply with the relevant general technical requirements of this edition of the "Chinese Pharmacopoeia". Corresponding historical editions of the pharmacopoeia, bureau (minister) issued standards are abolished.

The quality standards of preparation specifications and preparation methods of traditional Chinese medicines that are not included in the text of this edition of the Chinese Pharmacopoeia shall be implemented in accordance with the relevant requirements of the same variety in this edition of the Chinese Pharmacopoeia, and specifications and preparation items shall be implemented in accordance with the original approval documents.

4. If the drug registration standard contains more inspection items than or different from the pharmacopoeia, or the quality index is stricter than the pharmacopoeia requirements, the corresponding items and indicators of the registration standard shall be implemented on the basis of the pharmacopoeia requirements.

If the inspection items included in the drug registration standards are less than the pharmacopoeia regulations or the quality index is lower than the pharmacopoeia requirements, the pharmacopoeia regulations shall be implemented.





Haohan Chromatography (Shandong) Applied Technology Development Co., Ltd. takes the revitalization of national enterprises as its mission. According to the requirements stipulated in the 2020 Chinese Pharmacopoeia for carbon dioxide: the content of hydrocarbons is not more than 0.0020%, the HHO-III Purification device has been upgraded and transformed. , And named the 2021 NEW model, this device is more in line with the 2020 version of the Pharmacopoeia, with good purification effect, accurate and reliable quantification.

Haohan Chromatography provides detailed operation methods and installation drawings.


The test spectrum of the 2020 edition of "The Pharmacopoeia of People's Republic of China"