Pharmacopoeial count controlsPharmaCount™ Blank Low-particle-content DI Water (6 x 25 mL)Cat. No. 20000-25Pack size 6 x 25 mLPrice Pharmacopoeial count controls
PharmaCount™ 1510 Count Control <USP788>, box of 3 kits (25 mL each)
- Cat. No.
- Ph1510a25
- Diameter
- 12.2, 20 µm
- Pack size
- 3 x 25 mL
- Type
- Certified reference material
- Manufacturer
Technical data
| Nominal diameter | 12.2, 20 µm |
|---|---|
| Form | suspension |
| Concentration | Per the USP count standard |
| Standard | USP <788> / <1788.1> |
| Contents | 3 suspension and 3 blank bottles, 25 mL each |
| Material | Monodisperse polystyrene microspheres |
| Traceability | Diameters traceable to SI, including NIST |
| Certificate | Certificate of traceability with every pack, suitable for GMP records |
| Mixing | Magnetic stir bar in every bottle |
| Pharmacopoeias | USP <788> and <1788.1> (light obscuration), USP <729> (lipid injectable emulsions), JP 6.07 and KP 1613 (insoluble particulate matter in injections) |
| Formats | 6 x 25 mL, 2 x 50 mL, 25 mL kits with blank |
| Use | Intermediate instrument control; does not replace official pharmacopoeial standards |
Description
PharmaCount series: polystyrene microsphere suspensions with a defined number of particles, to keep liquid particle counters under control in pharmaceutical quality control laboratories working to the US, European, Japanese and Korean pharmacopoeias. They reproduce the characteristics of the standards called for by the methods (USP <788> and <1788.1>, USP <729>, JP and KP) and are meant for routine checks in GMP environments, without replacing the official pharmacopoeial standards. Diameters traceable to SI, including NIST; every pack comes with a certificate of traceability, and the bottles hold a magnetic stir bar for uniform dispersion during sampling.
Applications
- Intermediate control of light obscuration counters for USP <788> and <1788.1> (PharmaCount US, 1510)
- Insoluble particulate matter test for lipid injectable emulsions, USP <729> (PharmaCount BiCal)
- Instrument control for the JP and KP test on injections (PharmaCount JPKP)
- Calibration of SPOS instruments using light extinction and/or scattering with three diameters (PharmaCount TriCal)
- Background check with low-particle water (PharmaCount Blank)
What you receive
Certificate
Lot certificate with certified diameter or concentration, traceable to NIST and SI.
Import and shipping
Import, customs and Italian invoice handled by VitaSan Labs, tracked shipping.
Technical support
We help you choose diameter, concentration and format for your instrument and method.
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Are the standards traceable?
Yes: mean diameter, standard deviation and uncertainty are traceable to NIST and the International System of Units (SI) and stated on the certificate of every lot. The ISO/IEC 17025 series is certified by an accredited metrology laboratory.
Which control do I need for USP <788>?
For subvisible particle counting in injectables, use the PharmaCount controls: the USP <788> set for routine verification, the 3M and PC sets for single diameters. For USP <729> there is PharmaCount BiCal.
Can I order a diameter I do not see?
Yes: other diameters, concentrations and dyes are available on request. Tell us the value you need and we will send a quote.
How do I see the prices?
List prices per pack, excluding VAT, are shown after signing in to the customer area. With the quote request we confirm price, availability and delivery time.