SOP for Melting Point Apparatus : Pharmaceutical Guidelines

SOP for Melting Point Apparatus

Standard operating procedure of Melting Point Apparatus used to detect the melting point of powders.


       To describe the procedure for operation and calibration of Melting Point apparatus

2.0  SCOPE

       This SOP is applicable for operation and calibration of Melting Point apparatus.


       Officer/ Executive  - Quality Control


       Manager    - Quality Control


5.1  Operation

5.1.1  Ensure that the working area is clean.
5.1.2  Ensure that the instrument is connected to the power supply.

5.1.3   Display will be appear :
14/10/12         13:36:55
TEMP.    : 35.5 ºC
SPEED   : 5


5.2  About start menu                                                                    


5.2.1  Press “MENU/START” key
5.3  Test
5.3.1  Press “ENTER”  key or press ‘1’ no. key.
Product ID
Batch number

5.3.2  The display will appear ,
5.3.3  The Product ID and Batch number can be change with the help of alphabet key. By using “UP/DOWN” key and then press ‘ENTER’ key.
5.3.4  If required to delete any words / number Press “0/STOP” key.
5.3.5  Fill the powder sample in one sealed capillary about 3 to 4 mm and insert in one of the hole provided on the heater stand.
5.3.6  Press “RECORD NEXT” key the display will be appear.
Melting SP       :   00.0
Speed                :   0
Press START   to run

5.3.7  Select the melting speed with the “UP/DOWN” key.
5.3.  Enter required melting range in a degree centigrade and speed with the help of numerical  key and the press  “ENTER” key.
5.3.9  Press “MENU/START” key the display will appear as.
T speed  : 5        13:35:55
ID : XYZ       
MELT POINT : 083.0
ACT Temp.      : 035.0

MELT POINT : 082.0 indicate the set Temp.
ACT Temp. : 033.0 indicate the oil bath temp. 
5.3.10  The heater will become “ON” and temperature will start rising. The “GREEN” indicator lamp will start flashing (indicate the heater is ON) and on the display it is.
5.3.11  ACT temperature will start rising, the first buzzer will sound approximately 15.0 ºC before set temp. From this point of temp. the rate of temp. will attain 1.0º C per minute
5.3.12  The  second buzzer will sound before 5.0 ºC, i.e. at 77.0 ºC and the temp. will continue to rise at 1.0 ºC per minute. This audio signal intimate the user that the temp. is approaching close to melting point. On observing the melting of sample.
5.3.13  Press “RECORD NEXT” key and observe the START OF MELTING POINT by pressing “RECORD NEXT” key
T  Speed  : 5        13:35:55
ID : XYZ      
MELT POINT : 082.9
ACT Temp.      : 082.9

5.3.14  The display will appear as.
5.3.15  To observe further change in the melting of sample, then press same “RECORD NEXT” key again. Five times the change can be observed.
5.3.16  This recorded temperature along with the header, rise in temperature/ minute, and melted temperature will get printed. The printer should be connected to the printer port provided on rare side of the instrument and kept on and loaded with paper.
5.3.17  Record the test in usage log book.
5.4  Unknown Sample
5.4.1  If the melting point of the sample is not known.
5.4.2  To select unknown option either press ‘3’ no. key or press ‘DOWN” key.
ID :       
RATE   : 1:00

5.4.3  The display will be appear as.
5.4.4  The curser on message ID is flashing.
5.4.5  Press “ENTER” key the cursor will move third line. Select product name / batch number with the help of alphabet key. And press “ENTER” key.
5.4.6  The curser will move to fourth line. Select the RATE OF HEATING as per the requirement.
5.4.7  In this case rate of heating is selected as ‘5’. The display will appear as.
ID :       
RATE   : 5:00

5.4.8  Press “RECORD NEXT” key. The display will appear as.
SPEED :  5
Press start to run


5.4.9  Press MENU/ START key. The display will appear as.                              
UNKNOWN            13:35:55
SPEED :  5
Act Temp 

5.4.10  The  heater will become ON the temp. start rising at approx 5 ºC/min.
One has to observe to melting point of a sample manually, and when it is melt for e.g. the sample melt at 187.2 ºC (It indicates the melting point may be between 182.0º C to 192.0 ºC ).
5.4.11  Press STOP key. The heating will stop with audio signal. The display will appear as. 
14/10/12                   13:35:55
ACT TEMP. : 177.8
SPEED :  5

5.5  Utility
5.5.1  To select the “UTILITY” option either press ‘4’ no. key. And then press ENTER key. The display will appear as.          
Password : 0

5.5.2  The cursor on message password is flashing. Press ENTER key. The cursor will shift. Then press 1111 as code value. The display will appear password.
1         Print
2         RTC
3         Product IDs
4         Change password

5.5.3  Press ENTER key. The display as.
5.5.4  Print
          The print option is for printing the Test store data with date wise.  To select print option with UP/DOWN key. And press ENTER key. The displays will appear as.
From    :  DD/MM/YY
To         :  DD/MM/YY
Found   : 25
Dbl : NO                PRINT : NO  Select the date, month and year with the help of numerical key which required to printing.  If double-spacing between the two line is required, in the printing. Select YES with the help of  UP/DOWN key.  If print required  select YES with the help of  UP/DOWN key.  Press enter key it will start print all 25 record.
5.5.5  Clock  To enter the current date and time press ‘2’ key. Then press ENTER key the display will appear as.
Set date  :  DD/MM/YY
Set Time :  13:35:55  Select the date and time with the help of numerical key.  To go to main menu, press “ESCAPE PREV” key.
5.5.6  Product IDs
In this option will be store 10 products with its products name and their expected melting point.
Product ID  
Set point  :  Press ‘3’ key. The display will appear as.  To enter the product name and melting point (set point) with help of numerical /up and down key. And then press ENTER key.  Press RECORD NEXT key. Follow the same steps as explained to store regular 10 products.  To go to main menu, press “ESCAPE PREV” key.
5.5.7  Change passwords
The option ‘Change passwords’ is for factory setting.

5.6  Calibration

5.6.1  To calibrate the instrument with standard powders.
           A] VANILINE, having melting point 81.0 ºC to 83.0 ºC.
           B] BENZOIC ACID, having melting point 121.0 ºC to 123.0 ºC.
           C] CAFFINE, having melting point 235.0 ºC to 237.5 ºC.   
5.6.2  To select validation option. Press STARTMENU key.
5.6.3  To select validation option. Press ‘2’ no. key or press “DOWN” key. And then press “ENTER” key. The display will appear as.                                                        
Product ID
Batch number


5.6.4  Press “RECORD NEXT” key. If option for validation sample VANILINE is selected then, press “RECORD NEXT” key.
5.6.5  Fill the powder sample in one end sealed capillary about 3 to 4 mm and insert in one of the hole provided on the heater stand.
5.6.6  Press “MENU/START” key.
5.6.7  Follow the procedure as explained in the actual test of sample (from 5.3.9 to 5.3.15).
5.6.8  If want to validation for second / third sample press ESCAPE PREV key. And follow same above procedure. 
5.6.9  Calibrate the instrument and make entry in logbook.
5.6.10  Calibration frequency:  Quarterly.


6.1  SOP - Standard Operating Procedure
6.2  ID - Identification
6.3  ACT - Actual  Temperature

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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