Molekula
Particle Count Set (2 blanks (28 mL each) and 2 suspensions (25 mL each)) - USP CRS
Supplying 4,500+ customers in over 80 countries
ISO 9001:2015 & ISO 14001:2015 certified · Supplying laboratories and industry since 1999 · Certificate of Analysis with every batch
The Particle Count Set (USP CRS) is a standardized reference material used for calibrating and validating particle counting instruments in pharmaceutical manufacturing and quality control. It consists of two particle-free water blanks used for background counts and two suspensions of known particle concentrations to ensure accurate measurement of particulate contamination in injectable drugs and other sterile products. This set complies with USP standards for particle counting, with each blank and suspension meeting USP <788> and <789> specifications. The blanks each contain 28 mL of particle-free water (diluent) for background counts, and the suspensions are 25 mL aqueous solutions containing non-viable particles of defined size and quantity. No signal word applies, and it is stored at ambient conditions. Molekula supplies this Particle Count Set from research to bulk quantities with full documentation and ISO 9001:2015 traceability.
This substance is available from Molekula on enquiry. Full specification, Safety Data Sheet and Certificate of Analysis documentation are provided with your quotation once our team confirms the grade and pack size you need.
Overview
- SKU
- 90036684
- CAS Number
- 9003-53-6
- Molecular Formula
- N/A
- Molecular Weight
- N/A
See the other grade of CAS 9003-53-6 →
Frequently asked questions
What is the Particle Count Set (USP CRS) used for?
This set is used for validating and calibrating particle counting instruments in compliance with USP <788> for pharmaceutical applications, ensuring accurate detection of subvisible particles in injectable drugs.
What is the CAS number for this Particle Count Set?
The CAS number listed for this Particle Count Set is 9003-53-6, which is the CAS number for polystyrene and identifies the polystyrene latex microspheres in the suspensions.
How should the Particle Count Set be stored?
Store at ambient temperature (20–25°C) in a clean, dry environment, protected from contamination and light.
Is this Particle Count Set available in bulk quantities?
Molekula can supply bulk quantities of this USP CRS Particle Count Set upon request—contact us for pricing and lead times.
What documentation comes with the order?
Each order includes a Certificate of Analysis (CoA), Safety Data Sheet (SDS), and USP Certificate of Reference Standard (CRS) for traceability and compliance.
What grade is this Particle Count Set?
This is a USP Certified Reference Standard (CRS) grade, specifically designed for pharmaceutical particle counting validation.
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Molekula has supplied fine chemicals and biochemicals since 1999, and its facilities are ISO 9001:2015 and ISO 14001:2015 certified. Every dispatched batch is logged with a batch number and matched to a Certificate of Analysis, and Safety Data Sheets are available in five languages.