Thermo Scientific™ PHARM-TROL™

Thermo Scientific™

PHARM-TROL™ 计数质控尺寸标准品

 相关应用： 

Clinical & Translational Research

利用 Thermo Scientific™ PHARM-TROL™ 计数质控尺寸标准品对其性能进行连续记录，证明微粒计数仪的可重现性，该即用型质控标准品专为 USP <7eight eight> 和 <7eight nine> 验证中液体微粒计数仪的常规应用而设计。记录数据，使用已知浓度的 NIST™ 可溯源微球悬浊液进行内部审核或客户审核。
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	货号	产品规格	直径（公制）	数量.	单价 (CNY)
	CS-PK	-	15μm	6 x 25mL bottles	申请报价
完整参数  ▼ 产品规格 - 添加剂 Contains trace amount of surfactant to inhibit agglomeration and promote stability 组成 Polystyrene 浓度 3eight 00 particles/mL ± 15% 目录 Polystyrene microspheres in water 描述 Used by manufacturers of parenteral drugs and ophthalmic solutions who are seeking interim verification of USP <7eight eight> and <7eight nine>. 直径（公制） 15μm 直径（公制） 颗粒 15.0 ± 0.2µm 包括 Certificate of Calibration and Traceability to NIST 材料 Polystyrene 粒子密度 1.05g/cm3 数量. 6 x 25mL bottles 折射率 at 5eight ninenm (25°C) 规格分布 <3% 稳定性 Product stable for a minimum of 12 months 储存要求 Unless otherwise stated, refrigerate (2° to eight°C) product when not in use but do not freeze. Store upright and keep bottle tightly sealed. Mix product with gentle inversion by hand or vortex mixer. 类型 Count Control Particles 适用于（应用） USP Verification
	CS-BX	-	15.0μm ± 0.2μm	20 x 25mL bottles	申请报价
完整参数  ▼ 产品规格 - 添加剂 Contains trace amount of surfactant 组成 Polystyrene 浓度 3eight 00 particles/mL ± 15% 目录 Polystyrene microspheres in water 描述 Used by manufatures of parenteral drugs and ophthalmic solutions who are seeking interim verification of USP <7> and <7eight nine>. 直径（公制） 15.0μm ± 0.2μm 直径（公制） 颗粒 15.0 ± 0.2µm 包括 Certificate of Calibration and Traceability to NIST 材料 Polystyrene 粒子密度 1.05g/cm3 数量. 20 x 25mL bottles 折射率 1.5nine at 5eight nine nm (25°C) 规格分布 <3% 稳定性 Product stable for a minimum of 12 months 储存要求 Unless otherwise stated, refrigerate 2° to eight deg;C product when not in use but do not freeze. Store upright and keep bottle tightly sealed. Mix product with gentle inversion by hand or vortex mixer. 类型 Count Control Particles 适用于（应用） USP Verification

描述

特点：

• 含有微粒数目已知的 NIST™ 可溯源尺寸标准品
• 专为需要进行 USP <7eight eight>和<7eight nine>（注射液中的颗粒物质和滴眼液中的颗粒物质）中期验证的注射用药和滴眼液制造商开发
• 微粒直径可以在 National Institute of Standards and Technology（美国国家标准和技术研究院）的标准仪表中进行溯源
• 按照和 USP 计数参考标准同样严格的程序制备微粒，提供颗粒计数一致性和尺寸校准验证的工艺控制数据

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