Registration Dossier

Diss Factsheets

Physical & Chemical properties

Density

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
density, other
Remarks:
mean pour density and tapped density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017-01-07 – 2017-01-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Experimental result using standard methods analysis
Qualifier:
according to guideline
Guideline:
OECD Guideline 109 (Density of Liquids and Solids)
Principles of method if other than guideline:
The density of Test item Potassium hydrogen phthalate (CAS No. 877-24-7 ) was determined following OECD guideline 109 and according to the method recommended in the International Pharmacopoeia, fourth Edition, 2014.
GLP compliance:
not specified
Type of method:
other: mean pour density and tapped density
Specific details on test material used for the study:
- Name of test material (as cited in study report): Hydrogen potassium phthalate
- Molecular formula : C8H5O4K
- Molecular weight : 204.221 g/mol
- Smiles notation : c1(c(cccc1)C(=O)[O-])C(O)=O.[K+]
- InChl : 1S/C8H6O4.K/c9-7(10)5-3-1-2-4-6(5)8(11)12;/h1-4H,(H,9,10)(H,11,12);/q;+1/p-1
- Substance type:Organic
- Physical state:Solid
Key result
Type:
pour density
Density:
0.909 g/cm³
Temp.:
25.9 °C
Key result
Type:
tap density
Density:
1 g/cm³
Temp.:
25.9 °C

FOR SOLIDS:

By Pour Density and Tapped Density Method:

Method Details

Observations

Guideline

OECD 109

1stReading

2ndReading

Method

Test methods: Pour density and tapped density of

powders” recommended in

The International

Pharmacopoeia, Fourth

Edition, 2014

 

 

Principle of method

Pour Density:It is the ratio of known weight of test item and its volume in graduated

glass cylinder.

Tap Density: It is the

difference between the

volume of test item

measured before & after tapping in the graduated glass cylinder.

 

 

Test temperature (°C)

 

25.9°C

25.9°C

Atmospheric

pressure (in hPa)

 

976.4

977.1

Weight of test

item(m)

 

20.005

20.002

Volume of measuring

cylinder; readability

in g

 

250ml ; 2 ml

250 ml; 2ml

Volume of test item

without tapping (V)

 

22

22

Volume of test item

after tapping ( V1)

After 10 tapping

20

20

 

After 50 tapping

20

20

 

After 100 tapping

20

20

 

After 250 tapping

-

-

 

After 500 tapping

-

-

 

After 750 tapping

-

-

 

CALCULATIONS:

FOR SOLIDS:

By Pour Density and Tapped Density Method:

Parameters

Details

Calculated values

Average

Density

 

 

1st

Calculation

2nd

Calculation

 

Pour Density of test Item

(g/cm³)

m/v

20.005/22

=0.9093

20.002/22

=0.9091

0.9092

Tap density of test Item

(g/cm³)

m/v

20.005/20

=1.000

20.002/20

=1.000

1.000

 

Conclusions:
The density of Potassium hydrogen phthalate (CAS No. 877-24-7)was determined following OECD Guideline 109 and according to the Test methods: Pour density and tapped density of powders” recommended in The International Pharmacopoeia, Fourth Edition, 2014 using bulk density apparatus.The mean pour density and tapped density of chemical Potassium hydrogen phthalatwas determined to be 0.9092 g/cm³ and 1.000 g/cm³at 25.9°C and 976.7 hPa.
Executive summary:

The density of Potassium hydrogen phthalate (CAS No. 877-24-7)was determined following OECD Guideline 109 and according to the Test methods: Pour density and tapped density of powders” recommended in The International Pharmacopoeia, Fourth Edition, 2014 using bulk density apparatus.The mean pour density and tapped density of chemical Potassium hydrogen phthalat was determined to be 0.9092 g/cm³ and 1.000 g/cm³at 25.9°C and 976.7 hPa.

Description of key information

The density of Potassium hydrogen phthalate (CAS No. 877-24-7)was determined following OECD Guideline 109 and according to the Test methods: Pour density and tapped density of powders” recommended in The International Pharmacopoeia, Fourth Edition, 2014 using bulk density apparatus.The mean pour density and tapped density of chemical Potassium hydrogen phthalatwas determined to be 0.9092 g/cm³ and 1.000 g/cm³at 25.9°C and 976.7 hPa.

Key value for chemical safety assessment

Relative density at 20C:
0.909

Additional information

The density of Potassium hydrogen phthalate (CAS No. 877-24-7)was determined following OECD Guideline 109 and according to the Test methods: Pour density and tapped density of powders” recommended in The International Pharmacopoeia, Fourth Edition, 2014 using bulk density apparatus.The mean pour density and tapped density of chemical Potassium hydrogen phthalatwas determined to be 0.9092 g/cm³ and 1.000 g/cm³at 25.9°C and 976.7 hPa.

Other supporting study from various reliable handbooks suggests that the density of chemical Hydrogen potassium phthalate was reported to be 1.636 g/cm3 at 25 degree C.

As the data from lab has K1 reliability and the test was performed using OECD guidelines which has the value of mean pour density and tapped density as 0.9092 g/cm³ and 1.000 g/cm³ respectively,thus considered as key study for the chemical safety assessment.

Categories Display