USP789眼用注射劑中的不溶性微粒

性能驗(yàn)證標(biāo)準(zhǔn)，PSS Accusizer™自動稀釋器/APS配置的

• 三模態(tài)PQ檢查標(biāo)準(zhǔn)，用于驗(yàn)證尺寸與數(shù)量的準(zhǔn)確性

粒徑分析系統(tǒng)（PSS）Accusizer 780 SPOS儀器，采用AD/APS配置

• 體積：125毫升

• 標(biāo)準(zhǔn)材料：可追溯至NIST標(biāo)準(zhǔn)的聚苯乙烯乳膠（PSL）微球

標(biāo)準(zhǔn)顆粒的名義尺寸與濃度：

• 0.8微米PSL – 1,250,000個顆粒/毫升

• 2微米PSL - 450,000顆粒/毫升

• 5微米PSL - 15萬顆粒/毫升

產(chǎn)品批次濃度將為標(biāo)稱濃度的±10%；單瓶標(biāo)準(zhǔn)品將認(rèn)證為平均濃度的±22%，顆粒尺寸將認(rèn)證為標(biāo)準(zhǔn)尺寸的±5%（±不確定度）

符合性證書包含實(shí)際濃度測試數(shù)據(jù)及平均粒徑

MML PSL粒子

Gillson Sciences為制藥、生物技術(shù)和工業(yè)實(shí)驗(yàn)室提供高精度顆粒計數(shù)及粒徑標(biāo)準(zhǔn)。

儀器性能驗(yàn)證（PQ）標(biāo)準(zhǔn)

USP789眼用注射劑中的不溶性微粒

Performance qualification particle standard

性能驗(yàn)證（PQ）標(biāo)準(zhǔn)粒子

這個粒子根據(jù)Micro Measurement Laboratories,Inc**版本的H061標(biāo)準(zhǔn)操作流程進(jìn)行生產(chǎn)的， preparation of performance qualification particle standards

貨號660-1025，標(biāo)準(zhǔn)粒子 TRI MIX FOR APS and AD COUNT STANDARD(0.8, 2 and 5 μm) MML 125mL 061A

061A- PQ Check Standard, Tri-Mix for PSS Accusizer™ Autodiluter / APS Configuration

PQ Check Standard, Tri-Mix for PSS Accusizer™ Autodiluter / APS Configuration

• Tri-modal PQ check standard designed to verify size and count accuracy of the

Particle Sizing Systems (PSS) Accusizer model 780 SPOS instrument in the AD / APS configuration

• Volume: 125 mL

• Standard material: NIST traceable size Polystyrene latex (PSL) spheres

• Nominal sizes and concentrations of standard particles:

• 0.8 μm PSL – 1,250,000 particles/mL

• 2 μm PSL - 450,000 particles/mL

• 5 μm PSL - 150,000 particles/mL

• Product batch will be ± 10% of the nominal concentration; individual standard bottles will be certified ± 22% of the mean concentration and particle sizes are certified ± 5% of the standard size (± uncertainty)

• The Certificate of Conformance includes actual concentration testing data and mean size