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瀏覽器自帶分享功能也很好用哦~1.我們服務(wù)的種類：
玻璃：鈉鈣輸液瓶；硼硅安瓿瓶、注射劑瓶；卡式瓶、預(yù)灌封注射器等；
塑料：輸液瓶、多層共擠輸液袋、滴眼劑瓶、藥用復(fù)合袋等；
橡膠：注射用溴/氯化丁基橡膠塞、覆膜膠塞；硅橡膠膠塞、墊片；預(yù)灌封、筆式注射器用溴/氯化丁基橡膠塞、墊片等；
2.我們研究的內(nèi)容：
（1）可提取物研究（模擬研究）
（2）浸出物研究
（3）安全性評估
3.我們研究的流程：
4.研究范圍（不僅限于）：4. Research scope (not limited to) :
1.《藥品包裝材料與藥物相容性試驗指導(dǎo)原則》（YBB00142002-2015）
2.《化學(xué)藥品注射劑與塑料包裝材料相容性研究技術(shù)指導(dǎo)原則（試行）》
3.《化學(xué)藥品與彈性體密封件相容性研究技術(shù)指導(dǎo)原則（試行）》
4.《化學(xué)藥品注射劑與藥用玻璃包裝容器相容性研究技術(shù)指導(dǎo)原則（試行）》
5.《中國藥典》2020年版
6.《ICH Q3C：Impurities：Guideline for Residual Solvents》
7.《ICH Q3D：Guideline For Elemental Impurities》
8.USP<232> Elemental Impurities
9.USP<381> Elastomeric closure for injection
10.USP<1663>Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery System
11.USP<1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/ Delivery System
1. Our service types:
Glass: sodium-calcium infusion bottle; Borosilicate ampoule bottle, injection bottle; Cassette bottles, pre-potting syringes, etc.;
Plastic: infusion bottle, multi-layer co-extruded infusion bag, eye drop bottle, pharmaceutical compound bag, etc.
Rubber: bromine/chlorinated butyl rubber plug for injection, coated rubber plug; Silicone rubber plug, gasket; Pre-potting, bromine/chlorinated butyl rubber plugs for pen syringes, gaskets, etc.;
2. What we study:
(1) Extractable Studies (simulation studies)
(2) Study on extracts
(3) Security assessment
3.Our research process:
①Information collection and evaluation
②Case study and design
③Extract study
④Extract data analysis, safety assessment
⑤Extractum method development
⑥methodology validation
⑦Extractum study
⑧Extractum data analysis, safety assessment
⑨Compatibility report
4. Research scope (not limited to) :
1.《藥品包裝材料與藥物相容性試驗指導(dǎo)原則》（YBB00142002-2015）
2.《化學(xué)藥品注射劑與塑料包裝材料相容性研究技術(shù)指導(dǎo)原則（試行）》
3.《化學(xué)藥品與彈性體密封件相容性研究技術(shù)指導(dǎo)原則（試行）》
4.《化學(xué)藥品注射劑與藥用玻璃包裝容器相容性研究技術(shù)指導(dǎo)原則（試行）》
5.《中國藥典》2020年版
6.《ICH Q3C：Impurities：Guideline for Residual Solvents》
7.《ICH Q3D：Guideline For Elemental Impurities》
8.USP<232> Elemental Impurities
9.USP<381> Elastomeric closure for injection
10.USP<1663>Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery System
11.USP<1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/ Delivery System
1.我們服務(wù)的種類：
玻璃：鈉鈣輸液瓶；硼硅安瓿瓶、注射劑瓶；卡式瓶、預(yù)灌封注射器等；
塑料：輸液瓶、多層共擠輸液袋、滴眼劑瓶、藥用復(fù)合袋等；
橡膠：注射用溴/氯化丁基橡膠塞、覆膜膠塞；硅橡膠膠塞、墊片；預(yù)灌封、筆式注射器用溴/氯化丁基橡膠塞、墊片等；
2.我們研究的內(nèi)容：
（1）可提取物研究（模擬研究）
（2）浸出物研究
（3）安全性評估
3.我們研究的流程：
4.研究范圍（不僅限于）：4. Research scope (not limited to) :
1.《藥品包裝材料與藥物相容性試驗指導(dǎo)原則》（YBB00142002-2015）
2.《化學(xué)藥品注射劑與塑料包裝材料相容性研究技術(shù)指導(dǎo)原則（試行）》
3.《化學(xué)藥品與彈性體密封件相容性研究技術(shù)指導(dǎo)原則（試行）》
4.《化學(xué)藥品注射劑與藥用玻璃包裝容器相容性研究技術(shù)指導(dǎo)原則（試行）》
5.《中國藥典》2020年版
6.《ICH Q3C：Impurities：Guideline for Residual Solvents》
7.《ICH Q3D：Guideline For Elemental Impurities》
8.USP<232> Elemental Impurities
9.USP<381> Elastomeric closure for injection
10.USP<1663>Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery System
11.USP<1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/ Delivery System
1. Our service types:
Glass: sodium-calcium infusion bottle; Borosilicate ampoule bottle, injection bottle; Cassette bottles, pre-potting syringes, etc.;
Plastic: infusion bottle, multi-layer co-extruded infusion bag, eye drop bottle, pharmaceutical compound bag, etc.
Rubber: bromine/chlorinated butyl rubber plug for injection, coated rubber plug; Silicone rubber plug, gasket; Pre-potting, bromine/chlorinated butyl rubber plugs for pen syringes, gaskets, etc.;
2. What we study:
(1) Extractable Studies (simulation studies)
(2) Study on extracts
(3) Security assessment
3.Our research process:
①Information collection and evaluation
②Case study and design
③Extract study
④Extract data analysis, safety assessment
⑤Extractum method development
⑥methodology validation
⑦Extractum study
⑧Extractum data analysis, safety assessment
⑨Compatibility report
4. Research scope (not limited to) :
1.《藥品包裝材料與藥物相容性試驗指導(dǎo)原則》（YBB00142002-2015）
2.《化學(xué)藥品注射劑與塑料包裝材料相容性研究技術(shù)指導(dǎo)原則（試行）》
3.《化學(xué)藥品與彈性體密封件相容性研究技術(shù)指導(dǎo)原則（試行）》
4.《化學(xué)藥品注射劑與藥用玻璃包裝容器相容性研究技術(shù)指導(dǎo)原則（試行）》
5.《中國藥典》2020年版
6.《ICH Q3C：Impurities：Guideline for Residual Solvents》
7.《ICH Q3D：Guideline For Elemental Impurities》
8.USP<232> Elemental Impurities
9.USP<381> Elastomeric closure for injection
10.USP<1663>Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery System
11.USP<1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/ Delivery System
滬ICP備2022003614號-1
