德国AM标准粒子微粒标准物质USP标准品-PharmaCou

PharmaCount™ BC

产品信息
 

类型	颗粒粒度标准物质
成分	聚苯乙烯或聚（苯乙烯-二乙烯基苯），表面活性剂（<0.1%）、防腐剂（<0.05%）
包装	溯源证书，化学品安全技术说明书（MSDS）
密度	1.05 g/cm3
折射率	1.59 @ 589nm (25℃)
储存要求	4-30℃
保质期	24个月

PC2000系列是由聚苯乙烯颗粒悬浮液组成的产品线，该悬浮液具有精确定义的颗粒数量。它专为制药质量控制实验室设计，用于液体颗粒计数器的校准和验证。遵循符合美国、欧盟、日本和韩国药典要求的QC协议的实验室需使用美国、欧盟、日本或韩国药典组织提供或定义的标准物质来执行强制性测试。 用于所有 PC2000系列产品的标准粒子可追溯至国际单位 (SI)，包括 NIST。用于生产PC2000系列产品的所有粒度分析和颗粒计数仪均使用经 ISO17025 认可实验室认证和 NIST可追溯标准粒子的标准物质进行校准。

PharmaCount™ BC 是一种颗粒尺寸和计数标准粒子，非常适用于按照美国药典 USP 729 的规定对脂质注射乳剂进行不溶性颗粒物测试。它被设计用于仪器控制，以6瓶25毫升的包装供应。每瓶包含两种不同大小的NIST可追溯的单分散聚合物微球，其标称直径分别为5 µm和10 µm，每毫升的颗粒数大约为400,000和200,000。每个瓶子里都有一个磁力搅拌棒，以确保取样时的最佳分散性和均匀性。
 

PharmaCount ™ BC
Part No.	20510
Nominal Diam.	5 µm, 10 µm
Nominal Count rate	per diameter*
Ratio (≥ 10 μm / ≥ 15 μm)	n.a.
Package	6 x 25 mL

AM公司介绍：


Applied Microspheres（埃德微）成立于 2011 年，位于荷兰莱顿市的中心，是 Distrilab Particle Technology 的关系企业。30 多年来，Distrilab 一直是欧洲粒子检测相关产品的主要供应商。
由于特定颗粒的产品的需求不断增长，以及多年来获得的丰富经验和专业知识，Applied Microspheres（埃德微）在德国美因茨建立了研究和生产中心。在过去的几十年中，使用可追溯到美国国家标准与技术研究院 (NIST) 标准的参考材料来验证和校准颗粒尺寸测量和颗粒计数仪器已成为普遍做法。随着对根据更多国际标准化程序 (ISO) 进行仪器校准和验证的需求不断增加，Applied Microspheres 开发了粒径标准和计数标准粒子，它们不仅可追溯至NIST，而且可追溯至 ISO 17025 认可实验室认证的参考材料。

Particle count and size reference standards

The PharmaCount™ series by Applied Microspheres is a product line consisting of polystyrene particle suspensions with precisely defined numbers of particles. It is designed for pharmaceutical quality control laboratories to facilitate calibration and validation processes for liquid particle counters. Laboratories observing QC protocols meeting the US, EU, Japanese and Korean Pharmacopeia requirements, are obliged to use standards supplied or defined by the US, EU, Japanese or Korean Pharmacopeia organisations to perform mandatory (6 monthly) tests.

Particles used for all PharmaCount ™ series products are traceable to the International System of Units (SI), including NIST. All particle sizing and counting instruments used for the production of the PharmaCount™ series of products are calibrated with reference standards certified by an ISO 17025 accredited laboratory and NIST traceable size standards.

PharmaCount™ US, Pharma-Count™ JP and PharmaCount™ BC meet the specifications of these standards and are therefore ideally suited to perform (intermediate) tests to ensure that their instruments are always correctly calibrated, thereby safeguarding USP, EU, JP and KP compliancy.

In addition, PharmaCount™ BC and PharmaCount™ TC are particle count control products that are specially designed to simplify the calibration of single particle optical sizing (SPOS) instruments, using light extinction and/or scattering, such as Accusizer instruments. These instruments are commonly used in pharmaceutical quality control laboratories and calibration can be troublesome. PharmaCount™ BC and PharmaCount™ TC shorten these time consuming procedures.

PharmaCount™ BC

PharmaCount™ BC is a particle size and count reference standard ideally suited for performing insoluble particulate matter tests for lipid injectable emulsions as prescribed by the United States
Pharmacopeia USP 729. It is designed for use as instrument control and supplied in packs of six 25 ml bottles. Each bottle contains two different size populations of NIST traceable monodisperse polymer microspheres with nominal diameters of 5 μm and 10 μm, with approximate counts of 400.000 and 200.000 particles per ml respectively. A magnetic stir bar is included in each bottle to ensure optimal dispersion and uniformity during sampling.