Molekula
Conjunto de conteo de partículas (2 blancos (28 mL cada uno) y 2 suspensiones (25 mL cada una)) - USP CRS
Particle Count Set (2 blanks (28 mL each) and 2 suspensions (25 mL each)) - USP CRS
Certificado ISO 9001:2015 e ISO 14001:2015 · Suministro a laboratorios e industria desde el año 2000 · Certificado de Análisis (CoA) con cada lote
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 empty blanks 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 are 28 mL glass vials, 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.
Resumen
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 empty blanks 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 are 28 mL glass vials, 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.
Precios y tamaños de envase
Especificaciones
| Property | Value |
|---|---|
| Appearance | Clear, milky liquid |
| Conclusion | Conforms to USP monograph |
Almacenamiento y manejo
| Property | Value |
|---|---|
| Temperatura de Almacenamiento | Ambient |
| Acidez | Neutral |
Identificación
| Property | Value |
|---|---|
| SKU | 90036684 |
| Número CAS | 9003-53-6 |
| Fórmula molecular | N/A |
| Peso molecular | N/A |
| SMILES | N/A |
| Código REACH | Y113 |
| Incluido en el listado TSCA | Sí |
| Código HTS | 39031900 |
| Código arancelario | 3903190090 |
Seguridad y GHS
Información detallada sobre seguridad disponible en el FDS — véase Documentos a continuación.
Documentos
Certificado de Análisis (CoA) por lote
Introduzca un número de lote o partida para recuperar el informe de análisis (CoA) correspondiente a esa partida específica. Podemos generar uno a partir de los datos de especificación si no hay ningún PDF disponible.
Sinónimos
No se han registrado nombres alternativos para este producto.
Preguntas frecuentes
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 for this Particle Count Set is **9003-53-6** (generic for USP reference standards).
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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