안내사항 |
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납기가 표기된 상품의 경우 일반적인 수입진행에 소요되는 기간이며, 상품에 따라 납기일정이 추가 될 수 있으니 참고부탁드립니다. |
Thermo Scientific™ PHARM-TROL™ Count Precision Size Standards
Description
Document the reproducibility of a particle counter by permitting a continuous record of its performance with Thermo Scientific™ PHARM-TROL™ Count Precision Size Standards, ready-to-use precision standards designed for regular use in liquid particle counters for USP <788> and <789> verification. Data is documented for internal or customer audits by using a NIST™-traceable microsphere suspension with a known concentration.
Features
· Contains NIST™-traceable size standards with a measured particle count
· Developed for manufacturers of parenteral drugs and ophthalmic solutions seeking interim verification of USP <788> and <789> verification (Particulate Matter in Injections and Particulate Matter in Opthalmic Solutions)
· Particle diameters traceable to the Standard Meter through the National Institute of Standards and Technology
· Prepared with the same exacting procedures as the USP Count Reference Standard, providing process control data for particle counting consistency and verification of size calibration
Applications
· Validating liquid particle
counters to meet
global pharmaceutical
regulations
· Checking for particulate
matter in injections
Specifications
|
Additive |
Contains trace amount of surfactant to inhibit agglomeration and promote stability |
Diameter (Metric) |
15μm |
Storage Requirements |
Unless otherwise stated, refrigerate (2° to 8°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. |
|
|
|
Particle Density |
1.05g/cm3 |
Refractive Index |
1.59 at 589nm (25°C) |
|
Products
Catalog
Number |
Nominal
Diameter |
Bottle
Size |
Count/mL |
Mfr. No. |
Aqueous Suspensions, Calibrated by Optical Microscopy
|
09-980-235
|
15 μm
|
6 x 25 mL
|
3800/mL ± 15% |
CS-PK
|
09-980-236 |
15 μm |
20 X 25 mL
|
3800/mL ± 15%
|
CS-BX
|