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Suzhou Yikang Environmental Testing Co., Ltd
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Main Products:

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Suzhou Yikang Environmental Testing Co., Ltd

  • E-mail

    changliu006@126.com

  • Phone

    18915420690

  • Address

    Room 402, Building 117, Shuangyin International, No. 1388 Dongfang Avenue, Wuzhong District, Suzhou

Contact Now

Injection water testing

NegotiableUpdate on 02/07
Model
Nature of the Manufacturer
Producers
Product Category
Place of Origin

Overview

The testing items for injection water usually include pH, nitrate, nitrite, ammonia, conductivity, total organic carbon, non-volatile matter, heavy metals, microbial limits, bacterial endotoxins, etc.

Product Details

SuZhouyikang Environmental Testing Co., Ltd. is a professional third-party testing organization that specializes inTesting of injection waterHas certain strength and experience in the field, and the following is its related introduction:


  • Company QualificationsSuzhou Yikang was established on December 25, 2019, and has obtained CMA certification, focusing on GMP compliance verification and confirmation services. Its team members have over 15 years of GMP related work experience in the pharmaceutical industry, and have assisted multiple companies in obtaining domestic and international certifications such as FDA/EMA/EU/PICS/WHO, possessing rich experience in GMP validation and testing.

  • detection capabilityInjection water testingProjects typically include pH, nitrate, nitrite, ammonia, conductivity, total organic carbon, non-volatile compounds, heavy metals, microbial limits, bacterial endotoxins, etc.

  • Scope of ServicesThe company's main business includes clean room environment testing, process water system validation, process gas system validation, etc. It also provides GMP, GLP, GCP, GSP training services, etc. Its service scope covers the entire industry chain from upstream research and development production to downstream operation and maintenance services, providing one-stop compliance consulting services such as factory planning, registration system, training, and third-party testing.


  • The 2025 edition of the Chinese PharmacopoeiaTesting of injection waterThere have been some changes in the requirements, such as allowing the use of non distillation methods for preparation, making conductivity detection more critical, and adopting a dynamic monitoring and management strategy for microbial limits throughout the process. Suzhou Yikang Environmental Testing Co., Ltd., with its professional team and rich experience, is expected to provide customers with products that meet the requirements of the new pharmacopoeiaInjection water testingService.


Test Item

standard requirements

detection method

remark

trait

Colorless clear liquid

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conductivity

According to the method for measuring the conductivity of pharmaceutical water (general rules) 0681)When the conductivity of the solution meets the requirements determined by the injection water determination methodpHThe value can be controlled within5.0 - 7.0within the scope of

Determination of Conductivity of Pharmaceutical Water (General Principles) 0681

If the conductivity is determined to meet the requirements in the first step of the judgment method, nitrate, nitrite, and ammonia checks can be skipped

ammonia

When the conductivity of injection water≤1.3μS/cm25℃)At this time, the ammonia concentration can be controlled within0.2ppmbelow

According to the method under purified water, change the reference to ammonium chloride solution1.0ml

If the first step of determining conductivity meets the regulations, this project can be exempted

nitrate

According to the method under purified water, it should comply with the regulations

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If the first step of determining conductivity meets the regulations, this project can be exempted

nitrite

According to the method under purified water, it should comply with the regulations

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If the first step of determining conductivity meets the regulations, this project can be exempted

Total Organic Carbon

must not exceed0.50mg/L

General rule 0682

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bacterial endotoxin

each1mlThe amount of endotoxin in it should be less than0.25EU

General rule 1143

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Microbial Limit

According to the general rules 0261 Requirements for Microbial Monitoring of Pharmaceutical Water

General rule 0261