Calibration of Dissolution Apparatus- Physical

Calibration of Dissolution Apparatus- Physical

 

1. Temperature Calibration:     

 Acceptance Criteria: 37°C ± 0.5°C

Sr. No.	JAR No.	Set value	Observed Values
1.	JAR 1	37oC
2.	JAR 2
3.	JAR 3
4.	JAR 4
5.	JAR 5
6.	JAR 6
7.	JAR 7
8.	JAR 8
9.	JAR 9
10.	JAR 10
11.	JAR 11
12.	JAR 12

 

2. Paddle and Basket Wobble:                                                        Acceptance Criteria: For Basket NMT 1 mm                                                                   For Paddle NMT 1 mm

Sr. No.	Paddle No.	Observed Values for Paddle Wobble	Basket No.	Observed Values for Basket Wobble
1.	Paddle 1		Basket 1
2.	Paddle 2		Basket 2
3.	Paddle 3		Basket 3
4.	Paddle 4		Basket 4
5.	Paddle 5		Basket 5
6.	Paddle 6		Basket 6
7.	Paddle 7		Basket 7
8.	Paddle 8		Basket 8
9.	Paddle 9		Basket 9
10.	Paddle 10		Basket 10
11.	Paddle 11		Basket 11
12.	Paddle 12		Basket 12

 

 

3. Jar Centering:                                                                 Acceptance Criteria: NMT 2.0 mm

 

Sr. No.	JAR No.	Observed Values
1.	JAR 1
2.	JAR 2
3.	JAR 3
4.	JAR 4
5.	JAR 5
6.	JAR 6
7.	JAR 7
8.	JAR 8
9.	JAR 9
10.	JAR 10
11.	JAR 11
12.	JAR 12

 

4. Distance between Bottom edge of Basket (D1) and Paddle (D2):

Acceptance Criteria: 25.0 ± 2.0 mm

Sr. No.	JAR No.	Distance between Bottom edge of Basket (D1)	Distance between Bottom edge of Paddle (D2)
1.	JAR 1
2.	JAR 2
3.	JAR 3
4.	JAR 4
5.	JAR 5
6.	JAR 6
7.	JAR 7
8.	JAR 8
9.	JAR 9
10.	JAR 10
11.	JAR 11
12.	JAR 12

 

5. Timer calibration:

Sr. No.	Time (Minutes)	Acceptance Criteria	Observation
			Displayed Time	External Time
1.	5 min	5 min ±10 sec
2.	10 min	10 min ±20 sec
3.	20 min	20 min ±40 sec
4.	30 min	30 min ±60 sec
5.	60 min	60 min ±120 sec

 

6. RPM Calibration: Acceptance Criteria: RPM± 4%

1)For Paddle

Sr. No.	Paddle No.	RPM
		20 RPM (±1)	50 RPM(±2)	100 RPM(±4)	150 RPM(±6)	200 RPM(±8)
1.	Paddle 1
2.	Paddle 2
3.	Paddle 3
4.	Paddle 4
5.	Paddle 5
6.	Paddle 6
7.	Paddle 7
8.	Paddle 8
9.	Paddle 9
10.	Paddle 10
11.	Paddle 11
12.	Paddle 12

 

2)For Basket

Sr. No.	Basket No.	RPM
		20 RPM (±1)	50 RPM(±2)	100 RPM(±4)	150 RPM(±6)	200 RPM(±8)
1.	Basket 1
2.	Basket 2
3.	Basket 3
4.	Basket 4
5.	Basket 5
6.	Basket 6
7.	Basket 7
8.	Basket 8
9.	Basket 9
10.	Basket 10
11.	Basket 11
12.	Basket 12

 

7. Mesh Integrity: Acceptance Criteria: Mesh should not be damaged

 

Sr. No.	Basket No.	Observation
1.	Basket 1
2.	Basket 2
3.	Basket 3
4.	Basket 4
5.	Basket 5
6.	Basket 6
7.	Basket 7
8.	Basket 8
9.	Basket 9
10.	Basket 10
11.	Basket 11
12.	Basket 12

 

Standard Equipment’s used:

Sr. No.	Name of standard equipments	Sr. No. / ID No.	Date of Calibration	Valid upto
1.	Thermometer
2.	Wobble meter
3.	Centering device
4.	Depth gauge
5.	Tachometer
6.	Stop Watch

 

 

Remark: The results Complies/Does not comply as per acceptance criteria.

 

 

Performed By: ________________         Checked By: __________

 Date: ________________                           Date: _____________

 

“End of Document”