Hexadecyl dihydrogen phosphate

Particle size distribution (Granulometry)

Link to relevant study record(s)

Reference

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: End point assessed by manufacturer's spray dry facility. Actual PSD testing has been commisioned and will be reported as soon as results are available.

Justification for type of information:

End point assessed by manufacturer's spray dry facility for ColaFax CPE. Actual PSD testing has been commisioned and will be reported as soon as results are available.
The manufacturer makes it as an “intermediate” which is a waxy solid. Then it is outsourced to be spray dried and granulated. ColaFax CPE comes back as powder granules.

Qualifier:

equivalent or similar to guideline

Guideline:

other: ASTM D6913 / D6913M - 17

Version / remarks:

Simple sieve testing was used

Deviations:

not specified

Principles of method if other than guideline:

End point assessed by spray dry facility used by the manufacturer for ColaFax CPE, hexadecyl hydrogen phosphate. Actual PSD testing has been commisioned and will be reported as soon as results are available. Results supplied without further information on test method or conditions.

GLP compliance:

no

Type of method:

sieving

Type of particle tested:

agglomerate

Type of distribution:

mass based distribution

Percentile:

D50

Mean:

ca. 500 µm

Remarks on result:

other: Estimated based on sieve testing knowledge and assesment by the manufacturer

No.:

#1

Size:

> 840 µm

Distribution:

26 %

No.:

#2

Size:

>= 420 - <= 840 µm

Distribution:

40 %

No.:

#3

Size:

< 420 µm

Distribution:

34 %

Conclusions:

This substance is manufactured as an “intermediate” which is a waxy solid. It is then outsourced to be spray dried and powder granulated. ColaFax CPE comes back as granules.
Typical spray drying causes granular size of D50 of between 100 to 200 µm diameter range. The dry powder/ granules are often free-flowing.

Description of key information

This end point has been assessed as a temporary measure and formal PSD testing has been commissioned and will be reported as soon as available.

Historical data for ColaFax CPE, hexadecyl hydrogen phosphate material, from the spray dry facility who turn the product into a flowable powder granule suggest that the range is as follows

26%                                        >840 micron

40%                                        420 – 840 micron

34%                                       <420 micron