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EC number: 611-821-4 | CAS number: 5934-29-2
Particle size distribution (Granulometry)
Administrative data
- Endpoint:
- particle size distribution (granulometry)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 Feb 2018 - 12 Feb 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: CTL SOP No. 417
- GLP compliance:
- yes
- Type of method:
- Laser scattering/diffraction
- Type of particle tested:
- agglomerate
- Type of distribution:
- volumetric distribution
Test material
- Reference substance name:
- L-Histidine Hydrochloride Monohydrate
- EC Number:
- 611-821-4
- Cas Number:
- 5934-29-2
- Molecular formula:
- C6-H9-N3-O2.Cl-H.H2-O
- IUPAC Name:
- L-Histidine Hydrochloride Monohydrate
- Test material form:
- solid: crystalline
- Details on test material:
- - Name: L-Histidine Hydrochloride Monohydrate (HHM)
- Appearance: White crystals or crystalline powder
- Batch: P817T011
- CAS no.: 5934-29-2
- Purity/Composition: 100.1%
- Molecular weight: 209.63 g/mol
- Test item storage: room temperature
- Expiry date: 31 October 2020
Constituent 1
Results and discussion
- Mass median aerodynamic diameter:
- ca. 1 201.54 µm
- Geometric standard deviation:
- > 1.55 - < 1.597
Particle sizeopen allclose all
- Key result
- Percentile:
- D10
- Mean:
- ca. 548.508 µm
- St. dev.:
- 13.268
- Key result
- Percentile:
- D50
- Mean:
- ca. 984.346 µm
- St. dev.:
- 11.49
- Key result
- Percentile:
- D90
- Mean:
- ca. 1 569.632 µm
- St. dev.:
- 7.478
Any other information on results incl. tables
Using the identified parameters, the particle size was analysed over the range 0.02 µm to 2000 µm.
|
RUN 1 |
RUN 2 |
RUN 3 |
RUN 4 |
RUN 5 |
Average** |
Volume weighted mean |
1013.704 |
1011.696 |
1026.345 |
1031.181 |
1038.366 |
1024.258 |
Median |
971.514 |
969.554 |
990.413 |
991.871 |
997.882 |
984.346 |
Mode |
1068.34 |
1069.86 |
1103.677 |
1091.917 |
1087.888 |
1085.006 |
MMAD * |
1185.88 |
1183.49 |
1208.95 |
1210.73 |
1218.07 |
1201.54 |
d10 (10 % of material is <) |
539.005 |
535.069 |
541.777 |
556.722 |
570.795 |
548.508 |
d50 (50 % of material is <) |
971.514 |
969.554 |
990.413 |
991.871 |
997.882 |
984.346 |
d90 (90 % of material is <) |
1560.723 |
1560.231 |
1577.963 |
1573.226 |
1575.081 |
1569.632 |
All results are in µm
* Mass median aerodynamic diameter
** Average result is calculated from the entirety of data captured in each run and is not a simple arithmetic mean.
0.00 % by volume of sample was seen to be < 10.00 µm.
Run No. |
1 |
2 |
3 |
4 |
5 |
STDVP |
% STDVP |
d10 (10 % of material is <) |
539.005 |
535.069 |
541.777 |
556.722 |
570.795 |
13.268 |
2.4 |
d50 (50 % of material is <) |
971.514 |
969.554 |
990.413 |
991.871 |
997.882 |
11.49 |
1.2 |
d90 (90 % of material is <) |
1560.723 |
1560.231 |
1577.963 |
1573.226 |
1575.081 |
7.478 |
0.5 |
d15.78 (15.78 % of material is <) |
612.575 |
608.917 |
620.041 |
631.511 |
643.699 |
12.775 |
2 |
GSD |
1.586 |
1.592 |
1.597 |
1.571 |
1.55 |
0.017 |
1.1 |
MMAD |
1185.88 |
1183.49 |
1208.95 |
1210.73 |
1218.07 |
14.026 |
1.2 |
GSD = Geometric standard deviation of the lognormal particle size distribution (calculated from d50/d15.78) STDVP = standard deviation of the population
% STDVP = percentage standard deviation of the population
Coefficient of variation for d50 is less than 3%; d10 and d90 are less than 5%. Thus repeatability of the characteristic particles in the size distribution are within the acceptable limits as per the ISO 13320-1 test standard.
Applicant's summary and conclusion
- Conclusions:
- The particle size was analysed over the range 0.02 µm to 2000 µm using a DPM Module. The average result is calculated from the entirety of data captured in each of the five runs. The averages are: d10 - 10 % of material is <548.508, d50 - 50 % of material is <984.346, and d90 - 90 % of material is <1569.632 .
- Executive summary:
The particle size was analysed over the range 0.02 µm to 2000 µm using a DPM Module. The average result is calculated from the entirety of data captured in each of the five runs. The averages are: d10 - 10 % of material is <548.508, d50 - 50 % of material is <984.346, and d90 - 90 % of material is <1569.632 .
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