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Physical & Chemical properties

Particle size distribution (Granulometry)

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Reference
Endpoint:
particle size distribution (granulometry)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013.01.03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
no guideline followed
Version / remarks:
Micronization under GMP conditions, determination of particle distrbution by laser, Method no. E4250911(M)P
Principles of method if other than guideline:
Micronization under GMP conditions following validation procedure. Determination of particle distrbution by laser, Method no. E4250911(M)P
GLP compliance:
not specified
Other quality assurance:
other: GMP
Type of method:
Laser scattering/diffraction
Type of particle tested:
primary particle
Type of distribution:
other: Laser
Specific details on test material used for the study:
Batch numbers: EZ0023/EZ0024/EZ0025/EZ0026/EZ0027/EZ0028/EZ0029/EZ0030/EZ0031/EZ0032
Remarks on result:
not measured/tested
Key result
Percentile:
other: 98.56-99.53%
Mean:
<= 15 µm
Remarks on result:
other: no st.dev. reported
No.:
#1
Size:
<= 15 µm
Distribution:
>= 98.56 %
Remarks on result:
other: Percentage below 15 µm: 98.56% of the particles
No.:
#2
Size:
<= 15 µm
Distribution:
>= 99.53 %
Remarks on result:
other: Percentage below 15 µm: 99.53% of the particles
No.:
#3
Size:
<= 15 µm
Distribution:
>= 99.36 %
Remarks on result:
other: Percentage below 15 µm: 99.36% of the particles
No.:
#4
Size:
<= 15 µm
Distribution:
>= 99.13 %
Remarks on result:
other: Percentage below 15 µm: 99.13% of the particles
No.:
#5
Size:
<= 15 µm
Distribution:
>= 98.99 %
Remarks on result:
other: Percentage below 15 µm: 98.99% of the particles
No.:
#6
Size:
<= 15 µm
Distribution:
>= 98.8 %
Remarks on result:
other: Percentage below 15 µm: 98.8% of the particles
No.:
#7
Size:
<= 15 µm
Distribution:
>= 99.5 %
Remarks on result:
other: Percentage below 15 µm: 99.5% of the particles
No.:
#8
Size:
<= 15 µm
Distribution:
>= 99.38 %
Remarks on result:
other: Percentage below 15 µm: 99.38% of the particles
No.:
#9
Size:
<= 15 µm
Distribution:
>= 99.5 %
Remarks on result:
other: Percentage below 15 µm: 99.5% of the particles
No.:
#10
Size:
<= 15 µm
Distribution:
>= 99.04 %
Remarks on result:
other: Percentage below 15 µm: 99.04% of the particles
Conclusions:
The particle size distribution was determined for fusidic acid. Ten batches of fusidic acid were analysed and according to the results obtained between 98.56-99.53% of the particles are ≤ 15 µm.
Executive summary:

The particle size distribution was determined for fusidic acid. The product was micronized under GMP conditions and following a validation procedure

Ten batches of fusidic acid were analysed and according to the results obtained between 98.56-99.53% of the particles are ≤ 15 µm in size

Description of key information

Particle size distribution:

The particle size distribution was determined for fusidic acid. The product was micronized under GMP conditions following a validation procedure. Ten batches of fusidic acid were analysed and according to the results obtained between 98.56-99.53% of the particles are ≤ 15 µm.

The batch processing and analysis records were in compliance with GMP.

Additional information