Protein Surrogate Standard (MML SVPS)
Protein Surrogate Standard (MML SVPS)
  1. Protein Surrogate Standard (MML SVPS)
  2. Protein Surrogate Standard (MML SVPS)

Protein Surrogate Standard (MML SVPS)

061P-0030 & 061P-0060

Protein Surrogate Standard (MML SVPS)

  • Particle size and count check standard with a known polydisperse concentration of polymer particles that closely resemble images of aggregated protein particles in biologics when analyzed using Flow Imaging instruments.
  • The Certificate of Analysis includes actual concentration testing data and mean size

 

Clear

Share

SKU: N/A Category:
Volume

30 mL, 60 mL

Related products

  • PQ Check Standard, 5 & 10 µm Bi-Mix, USP <729 > Method 2 without Automatic Dilution

    PQ Check Standard, 5 & 10 µm Bi-Mix, USP <729 > Method 2 without Automatic Dilution

    Add to cart
  • PQ Check Standard, USP Count Reference Standard Surrogate

    PQ Check Standard, USP Count Reference Standard Surrogate

    Select options This product has multiple variants. The options may be chosen on the product page

    PQ Check Standard, USP Count Reference Standard Surrogate

    061UI-125 & 061UI-250 & 061UI-500 &061UI-1000

    PQ Check Standard, USP Count Reference Standard Surrogate 

    • Designed specifically to mimic the USP Count Reference Standard (USP CRS) used during annual calibrations of Light Obscuration (LO) particle counters running USP <788> sub-visible particle count tests on parenteral preparations, this standard is used to verify the performance of an LO instrument performing this test.
    • While it cannot be used in place of the USP CRS, this product should be used as a PQ Check in between annual calibrations to ensure the LO instrument is accurately counting particles in parenteral products. By running this standard weekly or bi-weekly, any out-of-specification (OOS) results can quickly be investigated and the instrument making the measurement can easily be ruled out (or confirmed) as the root cause of the OOS result.
      • Standard material: NIST traceable size Polystyrene latex (PSL) spheres.
      • Nominal size and concentration of standard particles:
        • 15 µm PSL – 3,750 particles/mL
      • Product batch will be ± 10% of the nominal concentration; individual standard bottles will be certified ± 15% of the mean concentration and particle sizes are certified ± 5% of the standard size (± uncertainty)
    • The Certificate of Analysis includes actual concentration testing data and mean size.

     

    Clear

    Share

    SKU: N/A Category:
  • Micro Measurement Laboratories, Inc. PQ-Check Standard: 100 microns Catalog #: 600-AB Read instructions BEFORE use Store in refrigerator (2°C to 8°C) Always sonicate & use new pipette

    50 µm Particle Count and Size Standard

    Select options This product has multiple variants. The options may be chosen on the product page

    50 µm Particle Count and Size Standard

    600-AA & 600-AB

    Particle Count and Size Standard

    • Volume: 1 L HDPE Bottle 
    • Standard material: NIST traceable size Polystyrene latex (PSL) spheres
    • Nominal sizes and concentrations of standard particles
      • Product batch will be ± 10% of the nominal concentration; individual standard bottles will be certified ± 15% of the mean concentration and particle sizes are certified ± 5% of the standard size (± uncertainty)
    • The Certificate of Analysis includes actual concentration testing data and mean size

     

    Clear

    Share

    SKU: N/A Category:
  • PQ Check Standard, 5 & 10 µm Bi-Mix, USP <729 > Method 2, AD/APS

    PQ Check Standard, 5 & 10 µm Bi-Mix, USP <729 > Method 2, AD/APS

    Select options This product has multiple variants. The options may be chosen on the product page

    PQ Check Standard, 5 & 10 µm Bi-Mix, USP <729 > Method 2, AD/APS

    061UF-0125 & 061UF-0250 & 061UF-0500

    PQ Check Standard, 5 & 10 µm Bi-Mix, USP <729 > Method 2 with Automatic Dilution

    • Designed specifically with USP <729> requirements in mind, prior to executing the “”Method 2″” SPOS PFAT-5 test, this standard is used to verify the performance of a Single Particle Optical Sensing (SPOS) particle counter equipped with an automatic dilution system.
    • Standard material: NIST traceable size Polystyrene latex (PSL) spheres.
    • Nominal sizes and concentrations of standard particles:
      • 5 µm PSL – 400,000 particles/mL
      • 10 µm PSL – 200,000 particles/mL
      • Product batch will be ± 10% of the nominal concentration; individual standard bottles will be certified ± 22% of the mean concentration and particle sizes are certified ± 5% of the standard size (± uncertainty)
    • The Certificate of Analysis includes actual concentration testing data and mean size.
    Clear

    Share

    SKU: N/A Category:
Skip to content