Water Content of Drug? Impact Of Water Content Of Drug. Methods Of Determining Water Content Of Drug. Formula for Water Content Determination. Calculation With Lab Practical Demo. Loss On Drying of Drug? Impact Of LOD Of Drug. Formula of LOD Determination. Calculation With Lab Practical Demo. Basic Difference.

1. Water Content Vs. Loss On Drying Of
Drug In Pharma Company

2. 1. Water Content of Drug?
2. Impact Of Water Content Of Drug.
3. Methods Of Determining Water Content Of Drug.
4. Formula for Water Content Determination.
5. Calculation With Lab Practical Demo.
6. Loss On Drying of Drug?
7. Impact Of LOD Of Drug.
8. Formula of LOD Determination.
9. Calculation With Lab Practical Demo.
10. Basic Difference.

3. 1. Water (moisture) content is the amount of water (traces) present in a drug |
Intermediates etc. in the form of wet cake or in final product.
2. It will impact Drug Substance or product quality differently, it must be
monitored at every stage of the production and delivery processes to ensure
the quality of the products are not diminished.
3. In the pharmaceutical industry, for drug substance or product the maximum
allowable moisture content should be known or as per applicable
pharmacopeia.
4. Its presence or lack thereof, in pharmaceutical products has a direct impact
on the quality.
5. Samples could be in solid or liquid form e.g. Finished API Drug in powder
form or liquid form. For Example: Quantity & Quality of Intermediate or API,
Gel Capsule, Urine or blood test strips

4. Intermediate & API:
1. Molar Ratio might get disturbed & hence impact the quality of forthcoming
stage.
2. Due Presence of moisture content beyond its limit, reaction mechanism might
get proceed in abnormal ways.
3. Any incident related to safety for Chemicals incompatible with traces of
moisture.
For example: 1. Calcium Hypochlorite, a combination base/oxidizer should
not be exposed to moisture or mixed with viscous fluid such as oil
2. Reaction with Na Metal
Consequence: Excessive heat, fire or explosion possible. Can provide an
ignition source for combustible materials.

5. Intermediate & API:
4. Due to presence of moisture traces more than the establish limit, might impact
the crystal form of final drug, or might be API produced in hydrated form etc.
5. May also impact the stability study of Intermediate | API Drug as hydrolytic
degradation of drugs with functional groups such as esters, amides, lactones, or
lactams, including many polymers.
6. Microbial Growth on Finished API | Intermediate.
7. Flow of API | Intermediates not as expected because of moisture content
8. Variations in weighing batches of raw materials or finished tablets
9. Clogging or caking in process equipment.
10. Moisture-permeable containers for packaging, and stability of the contents.

6. Drug Product (Formulated Drug):
1. In Drug formulation, we usually deal with physical property of
final product in place of chemical property.
2.Excessive or deficient moisture content can adversely impact the
physical properties of a drug product, which in turn affect the
chemical reactivity and binding properties that define the
product’s shelf-life.
3. Drug products may contain compounds that are harmful by skin
contact or inhalation and the moisture content is key to the
crystallization, agglomeration and the chemical form of these
compounds during tablet manufacture.

7. Drug Product (Formulated Drug):
4. The undesirable effect of moisture on chemical stability e.g. antibiotic
hydrolysis and physical stability e.g. change of dissolution rate,
disintegration.
.

8. 1. KF Moisture meter method
2. Oven drying method | LOD moisture meter method
3. Electrical moisture meter method
4. Microwave moisture meter method
5. Nuclear moisture meter method
6. Near Infrared moisture meter method
.

9. Formula for Water Content determination:
Where;
W1 : Net Weight of Drug Having Water Content
W2 : Net Weight of Water in Drug
W3 : Dry Weight of Drug
%Water
Content
=
(Total Wt. of drug) - (Wt. of dried drug)
X 100
(Total Weight of drug)
%Water
Content
=
(W1) - (W3)
X 100
(W1)
%Water
Content
=
Wt. of Water present
X 100
Total Weight of Drug Taken

10. So to understand the water content present in our drug substance, lets
we have a practical in laboratory.
From Lab Trial, We will obtain:
Tare Weight of Crucible
Weight of Drug having water content
Weight of dried drug

11. From Lab Trial, We will obtain:
Tare Weight of Crucible = 69.87 gm
Weight of Drug having water content = 0.50 gm
Gross Wt. of Drug with water content = 70.37 gm
Gross Wt. of Dried Drug = 70.34 gm
Weight of Water in drug = [(Gross Wt. Drug with water) –
(Gross Wt. of dried Drug)]
= 70.37 – 70.34 = 0.03 gm

12. Calculation Continue….
By Putting all obtained values in below formula:
This means our drug of weight 0.5 gm has 6% moisture
content i.e. exact qty of drug on dry basis is ________???
%Water
Content
=
Wt. of Water present
X 100
Total Weight of Drug Taken
%Water
Content
=
0.03 gm
X 100
0.50 gm
%Water Content = 6%