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Pharmaceutical analytical standards

Particle size standards.

Reference materials to calibrate and verify particle counters, particle sizing instruments and cytometers: polystyrene and glass microspheres, count controls for USP <788> and <729>, fluorescent microspheres and zeta potential controls. List prices are shown after signing in to the customer area.

Particle size standards

Particle size standards 43

Monodisperse polymer (polystyrene) microsphere suspensions to calibrate and verify instruments that measure particle size and number. The diameter is calibrated by electron and optical microscopy and confirmed with several independent methods (ESZ, SPOS, ADC, laser diffraction, DLS); traceability to NIST and to the SI metre runs through materials calibrated in an ISO/IEC 17025 accredited laboratory. Every lot has its own certificate with mean diameter, standard deviation and expanded uncertainty. NanoStandards from 20 to 990 nm and MicroStandards from 1 to 200 µm, in 20 mL dropper bottles stored at room temperature.

Series technical data
MaterialMonodisperse polymer (polystyrene) microspheres
FormAqueous suspension
MediumWater with traces of an antimicrobial agent and a surfactant for colloidal stability
DiametersNanoStandards 20-990 nm; MicroStandards 1-200 µm
Concentration (solids)1% up to 9 µm (w/v for NanoStandards); 2% from 10 to 90 µm; 3% from 100 to 200 µm
Pack20 mL dropper bottle
TraceabilityNIST (unbroken chain of measurements to NIST SRMs) and SI (metre), through reference materials calibrated by an ISO/IEC 17025 accredited laboratory
Diameter calibrationElectron (TEM, SEM) and optical microscopy, confirmed by orthogonal methods: ESZ, SPOS, ADC, laser diffraction, DLS
Lot certificateCertified mean diameter, standard deviation, expanded uncertainty
Shelf life36 months from the date of manufacture
StorageRoom temperature (4-30 °C)
ISO/IEC 17025 particle size standards

ISO/IEC 17025 particle size standards 5

Size standards from the NanoStandards and MicroStandards lines whose mean diameter is certified by an independent ISO/IEC 17025 accredited metrology institute, on material from the original lots. Beyond NIST traceability, usually obtained by in-house measurements against SRMs, here the measurement is performed under accreditation: atomic force microscopy (AFM) from 0.1 to 5 µm and laser scanning confocal microscopy (LSCM) from 10 to 30 µm. The certificate is ISO/IEC 17025 compliant and meets the requirements for instrument calibration in an accredited laboratory. 5 mL vials; each code states the certified mean diameter of the lot.

Series technical data
MaterialMonodisperse polymer (polystyrene) microspheres from the original NanoStandards and MicroStandards lots
FormAqueous suspension
Nominal diameters100, 300 and 500 nm; 1 and 5 µm
Certified mean diameter89.7 nm; 331.4 nm; 512.6 nm; 1.046 µm; 4.906 µm (by code)
CertificationIndependent metrology institute accredited to ISO/IEC 17025
Accredited methodsAtomic force microscopy (AFM) from 0.1 to 5 µm; laser scanning confocal microscopy (LSCM) from 10 to 30 µm
TraceabilitySI, including NIST
CertificateISO/IEC 17025 compliant
Pack5 mL vial
UseInstrument calibration under ISO/IEC 17025
Multi-size standards

Multi-size standards 1

Mixture of five monodisperse polymer microsphere populations, from 0.06 to 2 µm, in a single 1% aqueous suspension. It tests the resolution of particle sizers, for example laser diffraction instruments, in advanced operational qualification and size calibration, and helps determine the cut-off of filter media. The medium is formulated to prevent agglomerates and to remain stable over time. Certification covers d10, d50 and d90 or full traceability of the individual diameters.

Series technical data
Composition5 monodisperse populations of polymer (polystyrene) microspheres
Diameter range0.06-2 µm
FormAqueous suspension formulated against agglomerates, long-term stable
Concentration (solids)1%
Pack3 mL
Certificationd10, d50 and d90 values, or full traceability of the individual diameters
On requestOther diameter mixtures and distributions
Powder size standards

Powder size standards 34

Cross-linked polystyrene microspheres as dry powder, for size and count instruments that can only be calibrated with dry particles. The certified mean diameter is traceable to SI and NIST through standards certified by ISO 17025 accredited metrology institutes and NIST reference materials, with a calibration uncertainty below 2.5%: the level required by ISO 21501-4 for airborne particle counters. Density 1.05 g/cm³, refractive index 1.59 at 589 nm, diameters from 3 to 500 µm in 1 g bottles. They are not meant to be redispersed in water.

Series technical data
MaterialCross-linked polystyrene
FormDry powder (not well suited for redispersion in water)
Density1.05 g/cm³
Refractive index1.59 at 589 nm
Diameters3-500 µm (34 diameters)
Quantity1 g
Particles per gramAbout 6.7 × 10¹⁰ (3 µm) - 1.4 × 10⁴ (500 µm)
TraceabilitySI and NIST, through standards certified by ISO 17025 accredited metrology institutes and NIST SRMs
Calibration uncertaintyBelow 2.5%, as required by ISO 21501-4
Lot certificateCertified mean diameter
StorageRoom temperature (4-30 °C), away from direct sunlight
Glass size standards

Glass size standards 3

Glass microspheres as dry powder, used as size standards for powder particle sizing and for optical microscopy calibration, traceable to NIST and SI. Nominal diameters 50, 100 and 200 µm, in 1 g packs. Glass type, size distribution and certificate content are confirmed with the quote.

Series technical data
MaterialGlass microspheres
FormDry powder
Diameters50, 100 and 200 µm
Quantity1 g
TraceabilityNIST and SI
Size and count controls

Size and count controls 30

Size standard and count control in the same bottle: monodisperse polystyrene microspheres with diameter traceable to SI, including NIST, and number concentration checked on every lot, with a count uncertainty of ±10%. The low-residue aqueous medium keeps background interference to a minimum, and concentrations are ready for direct use or simple dilution in liquid laser particle counters. Refractive index 1.59 at 589 nm and density 1.05 g/cm³, so settling during the test is slow. 20 mL dropper bottles with long shelf life at room temperature.

Series technical data
MaterialMonodisperse polystyrene microspheres
Refractive index1.59 at 589 nm
Density1.05 g/cm³ (slow settling)
FormLow-residue aqueous suspension, formulated to reduce background
Diameters0.1-100 µm
Nominal concentrationFrom 10⁹ particles/mL (0.4 µm) to 10⁴ particles/mL (90-100 µm), referred to a threshold channel
Count uncertainty±10%
Diameter traceabilitySI, including NIST
CalibrationElectron or optical microscopy, ESZ, SPOS, laser diffraction and ADC, with reference materials from ISO/IEC 17025 accredited institutes and NIST SRMs
Pack20 mL dropper bottle
StorageRoom temperature (4-30 °C)
Pharmacopoeial count controls

Pharmacopoeial count controls 8

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.

Series technical data
MaterialMonodisperse polystyrene microspheres
FormReady-to-use aqueous suspension
TraceabilityDiameters traceable to SI, including NIST
CertificateCertificate of traceability with every pack, suitable for GMP records
MixingMagnetic stir bar in every bottle
PharmacopoeiasUSP <788> and <1788.1> (light obscuration), USP <729> (lipid injectable emulsions), JP 6.07 and KP 1613 (insoluble particulate matter in injections)
Formats6 x 25 mL, 2 x 50 mL, 25 mL kits with blank
UseIntermediate instrument control; does not replace official pharmacopoeial standards
Count control sets

Count control sets 11

PharmaCount 3M set: six 25 mL bottles of the same ready-to-use monodisperse microsphere suspension at 3,000 particles/mL, to set or check channel thresholds and count precision of liquid optical particle counters, with no dilution. The microspheres are polystyrene cross-linked with divinylbenzene (refractive index 1.59 at 589 nm, density 1.05 g/cm³), in an aqueous medium with dispersing agents that prevent clumping and adhesion to flow surfaces. Certified diameters are traceable to SI, including NIST, and every bottle has its own magnetic stir bar for direct sampling.

Series technical data
Content6 bottles of suspension, 25 mL each
Nominal concentration3,000 particles/mL
MaterialPolystyrene cross-linked with divinylbenzene (DVB)
Refractive index1.59 at 589 nm
Density1.05 g/cm³
MediumAqueous with dispersing agents against clumping and adhesion to surfaces
Diameters2-100 µm (11 diameters)
TraceabilityCertified diameters traceable to SI, including NIST
AccessoriesMagnetic stir bar in every bottle
UseReady to use, no dilution
Count control sets, PC series

Count control sets, PC series 11

PC series sets with the same composition and use as PharmaCount 3M: ready-to-use monodisperse microsphere suspensions at 3,000 particles/mL to check channel thresholds and count precision of liquid optical counters. Only the packaging differs: three bottles of suspension and three of blank, 25 mL each, so each test has its own background control. Polystyrene cross-linked with divinylbenzene, diameters traceable to SI and NIST.

Series technical data
Content3 bottles of suspension and 3 bottles of blank, 25 mL each
Nominal concentration3,000 particles/mL
MaterialPolystyrene cross-linked with divinylbenzene (DVB)
Refractive index1.59 at 589 nm
Density1.05 g/cm³
Diameters2-100 µm (11 diameters)
TraceabilityCertified diameters traceable to SI, including NIST
EquivalenceSame composition, properties and use as the PharmaCount 3M sets
Fluorescent microspheres

Fluorescent microspheres 54

Polystyrene microspheres with the fluorescent dye incorporated during polymerisation, so no dye leakage, in three colours: blue, green and red. Fluorescence is bright and very uniform from particle to particle, and it does not degrade in water or when the microspheres are dispersed in air. They are detected with flow cytometers, epifluorescence and confocal microscopes, fluorescence spectrophotometers and even with a black light, directly in the sample or collected on a membrane filter. 1% aqueous suspension in 3 or 50 mL bottles, or 1 g of dry powder for diameters from 5 to 20 µm.

Series technical data
MaterialPolystyrene with fluorescent dye incorporated in the matrix during polymerisation
ColoursBlue, green, red
Blue: excitation / emission380-450 nm / 440-520 nm
Green: excitation / emission400-490 nm / 470-560 nm
Red: excitation / emission450-570 nm / 550-660 nm
Diameters0.1; 0.5; 1; 5; 10; 15; 20 µm
Form1% aqueous suspension (solids) or dry powder
PacksSuspension 3 mL or 50 mL; powder 1 g (from 5 to 20 µm)
FluorescenceHigh intensity, low particle-to-particle variation, no dye leakage
StorageRoom temperature
Zeta potential controls

Zeta potential controls 3

Ready-to-use zeta potential controls: 200 nm surface-modified polystyrene particles, negatively (-60 mV) or positively (+60 mV) charged, to verify instruments that measure electrophoretic mobility or streaming potential. The medium contains no charged surfactants and is buffered against CO₂ uptake, so background signal is minimal and the chemical environment stays stable. Concentration suits the most common measurement set-ups, with a defined electrophoretic mobility value. Single-use Luer-lock syringes of 3 mL (6 per pack) or 10 mL (10 per pack), shelf life 12-18 months from manufacture at room temperature.

Series technical data
MaterialSurface-modified polystyrene particles
Nominal diameter200 nm
Nominal zeta potential-60 mV (negatively charged) or +60 mV (positively charged)
pH8.0 ± 0.5 (negative); 5.0 ± 0.5 (positive)
Solids0.02%
Density1.05 g/cm³
Refractive index1.59 at 589 nm
MediumFree of charged surfactants, buffered against CO₂ uptake
PackReady-to-use single-use syringes with Luer-lock fitting: 6 x 3 mL or 10 x 10 mL
MethodsElectrophoretic mobility and streaming potential
Shelf life12-18 months from the date of manufacture
StorageRoom temperature
Research grade suspensions

Research grade suspensions 2

Concentrated polymer microsphere suspensions at 10% w/w, with a narrow monomodal distribution (CV ≤ 5%) and an accurately measured diameter, for applications that need large amounts of material but not SI traceability. Diameters range from below 0.1 to above 100 µm and are usually not round values: for example 0.281 µm for a 0.280 µm nominal size. The most common use is filter testing, HEPA included, for exclusion limits and loading capacity; they also serve in sedimentation and centrifugation experiments and as calibrated spacers. 15 or 100 mL bottles, 36 month shelf life at room temperature.

Series technical data
MaterialPolymer (polystyrene) microspheres, monomodal distribution
FormConcentrated aqueous suspension (powder on request)
Solids10% w/w (gravimetric)
UniformityCV ≤ 5%
DiametersFrom below 0.1 to above 100 µm; values usually not rounded
TraceabilityNot traceable to SI (traceability on request)
Packs15 mL or 100 mL
Shelf life36 months from the date of manufacture
StorageRoom temperature (4-30 °C)
On requestSurface modification, fluorescent labelling, custom concentrations

Frequently asked questions

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.