What are the different types of safety factors used in the pharmaceutical industries?

Following safety factors are used in pharmaceutical manufacturing.

•  1/10 to 1/100th of a normal daily dose = Topical products

•  1/100 to 1/1000th of a normal daily dose =     Oral products

• 1/1000 to 1/10000th of a normal daily dose = Injectable & Ophthalmic products

• 1/10000 to 1/100000th of a normal daily dose = Research, investigational products.

What is the solubility data as per any Pharmacopoeia?

Different products have different solubility levels. The solubility of the product is determined by dissolving in know volume of solvent.

•  Approximately volume of solvent in ml per gram of solute at 20° to 30°C
• Very soluble : Less than 1
• Freely soluble : From 1 to 10
• Soluble : From 10 to 30
• Sparingly soluble : From 30 to 100
•  Slightly soluble : From 100 to 1000
•  Very slightly soluble : From 1000 to 10000
• Insoluble / practically soluble : More than 10000

 Example:  Very soluble means one gram of solute substance will require less than 1 ml of solvent.

What is the necessity of analytical method validation?

The principle purpose of analytical validation is to ensure that a selected analytical procedure will give reproducible and reliable results that are adequate for the intended purpose. It is thus necessary to define properly both the conditions in which the procedure is to be used & the purpose for which it is intended.

 It means that analytical method validation is to prove that the analytical method used for analysis of the product works perfectly.

Define Bio burden?

The level & type (i.e. objectionable or not) of microorganisms that can be present in raw materials, API starting materials, intermediates or APIs. Bioburden should not be considered contamination unless the levels have been exceeded or defined objectionable organisms have been detected.

 It means the bioburden is the number microbes present in the raw material or water sample. Bioburden does not claim any specific microorganism.

Describe the method of testing for checking of MOC of SS material (Molybdenum test)?

Procedure:

1.   Put one drop of the electrolyte solution of molybdenum test kit on the clean metal surface, which is to be tested.

2.       Switch on the detector and touch the metal tip of the detector on the metal surface & carbon point in the electrolyte solution.

3.       Do not pass the current for more than 3 to 4 seconds.

4.       If the red color appears and is stable for more than 2 seconds then it can be concluded that MOC of the part being tested is SS-316.

5.       If the solution remains colorless or green color appears then it can be concluded that MOC of the part being tested is SS-304.

6.       If the black color appears & is stable for more than 2 seconds then it can be concluded that MOC of the part being tested is SS-302.