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RheoSenseSeptember 11, 20142 min read

USP Expert Committee: Rectangular Slit Viscometer

RheoSense, Inc. (San Ramon, CA) — is proud to announce that VROC® technology, rectangular slit type viscometer, will officially be listed as a public standard under the US Pharmacopeia chapter <914> Viscosity — Pressure Driven Methods as Method I. 

Founded in 1820, US Pharmacopeial Convention (USP) is a nonprofit organization that works to establish and secure medicines and public standards for global health and safety. USP is built and supported by countless number of experts who have decades of experience when it comes to drug development, testing, and manufacturing. Published annually, these standards and guidelines are followed by manufacturers and regulated by federal law. All prescription and Over the Counter (OTC) medicines in the United States must meet USP standards.Pill

"Recognized and incorporated into the USP chapter is a great achievement" says CEO & Founder, Dr. Seong-Gi Baek, "we are certain that the benefits of the rectangular-slit method will bring further public awareness."

The chapter will include information on the rectangular-slit concept and the measuring principles with the viscometers. See all official content and details here

A recent article published by the USP on Pharmtech explains and confirms their recommendations by ensuring viscosity tests are conducted using suitable viscometers in the updated chapters, including chapter 914. 

Viscosity Chapter USP-NF Chapter Content 

<1911> Rheometry

USP 37-NF 32 (2014)

Introduction

  • Newtonian viscosity
    • Measurement of Newtonian viscosity using a capillary viscometer
    • Measurement of Newtonian viscosity using a rotational viscometer
  • non-Newtonian rheology
    • Measurement of viscosity using a rotational viscometer
      • Calculation of shear rate, shear stress, and viscosity using a concentric (coaxial) cylinder rheometer
      • Calculation of shear rate, shear stress, and viscosity using a cone-and-plate rheometer
Measurement of rheological properties using a nonrotational rheometer
<911> Viscosity -Capillary methods

USP 38-NF 33 (215)

Introduction

  • Method I. Suspended-level (or Ubbelohde-type) capillary viscometer
    • Apparatus
    • Procedure
    • Calibration
    • Calculation of kinematic and Newtonian viscosities of sample fluid
  • Method II. Simple-tube (Ostwald-type) capillary viscometer
    • Apparatus
    • Procedure
    • Calibration
    • Calculation of kinematic and Newtonian viscosities of sample fluid
Any other capillary viscometers may be used provided that the accuracy and precision are not less than those obtained with the viscometers described in this chapter
<912> Viscosity – Rotational Methods

USP 38-NF 33 (2015)

Introduction

  • Method I. Spindle viscometers
    • Apparatus
    • Procedure
    • Calibration check
  • Method II. Concentric cylinder Rheometers
    • Apparatus
    • Procedure
  • Method IV. Parallel plate (or parallel disk) rheometers
    • Apparatus
    • Procedure
<913> Viscosity – Rolling Ball Method

USP 38-NF 33 (2015)

Introduction

Only one method

  • Apparatus
  • Measuring principle
  • Procedure
Calculation and calibration

<914> Viscosity – Pressure Driven Methods

USP 39-NF 34 (2016)

Introduction

  • Method I. Slit viscometers/ rheometers
    • Apparatus
    • Measuring principle
    • Procedure
Calculation and calibration

 

H. Wang, L. Block, and C. Sheehan, "Characterization of Polymeric Excipients," Supplement to Pharmaceutical Technology 41 (4) 2017.

For further details and information on biopharmaceutical applications,

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RheoSense

RheoSense is a global high-tech company based in Silicon Valley. Our innovative m-VROC & microVISC instruments feature patented Viscometer/Rheometer-on-a-Chip (VROC) technology. Utilizing state-of-the-art MEMS and microfluidics breakthroughs that redefine the viscometry industry, our instruments offer the smallest sample volume per measurement coupled with exceptional ease-of-use and accuracy. We are the leader in biotechnology, pharmaceutical, and the emerging protein therapeutics industries. RheoSense instruments have been rigorously tested, approved, and adopted worldwide by Fortune Global 500 companies and leading research universities.

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