Recommended Results

Application PNR 12: Consistency Measurement According to the European Pharmacopoeia 2.9.9 and the U.S. Pharmacopeia (USP)

Suitable for products like white or yellow petrolatum (vaselinum album and flavum), ointment, wax and carboxymethylcellulose sodium paste.

PNR 12 - Test Principle

The PNR 12 is a gravity penetrometer and measures the resistance a material provides against being pierced by a specifically shaped test body.  The penetration, which is indicated in penetration units of 0.1 mm per unit, allows a rating of the plasticity or consistency.

The measurement of consistency by penetration is defined in part 2.9.9 of the European Pharmacopeia and also described by the U.S. Pharmacopeial Convention.

European Pharmacopoeia 2.9.9

The penetration test according to the European Pharmacopoeia 2.9.9 is an official method, especially for pharmacy products like vaselinum.

A WHO (World Health Organization) document with the detailed description of the whole procedure can be found under: apps.who.int/phint/en/p/docf/ (search under: Supplementary information → Test methods used during development or manufacture → Measurement of consistency by penetrometry)

Test kits according to the European Pharmacopoeia 2.9.9 and the U.S. Pharmacopeial Convention:

Test kit 1: Micro Cone acc. to Klein (Pharma)

 

Test kit 2: Optional Hollow Cone (Petrolatum)

 

Test kit 3: Tapered Needle (Wax)

106933 - Optional Hollow Cone Kit 
consisting of:
1 optional hollow cone (102.5 g),
1 plunger (47.5 g),
3 three-section grease containers

106938 - Micro Cone Kit acc. to Klein
consisting of:
1 micro cone (7.0 g),
1 plunger (16.8 g), 1 centering disk,
3 three-section grease containers

106932 - Tapered Needle Kit (for wax)
consisting of:
2 tapered wax needles (2.5 g),
1 plunger (47.5 g), 1 load weight (50 g),
3 wax test cylinders with base plates,
1 transfer dish with heat exchange tube,
1 thermometer ASTM 64C

Please refer to the corresponding application report.

162194 - Pharma Qualification Package “Smart” Document
consisting of:
- Standard Operating Procedure
- Qualification Instruction
- Design Qualification
- Installation Qualification
- Operation Qualification
- Performance Qualification
- Final Qualification

Additionally the electric surface-detector (included in the supplied parts of the PNR 12) for automatic surface detection of electrically conductive samples <20 MΩ can be used.

Do you have any questions?

Contact Anton Paar ProveTec directly: support.provetec[at]anton-paar.com

Learn more about the PNR 12

Good to know

U.S. Pharmacopeia (USP) - The USP describes the consistency measurement by penetration method for white petrolatum, carboxymethylcellulose sodium paste and microcrystalline wax.