Sop for force degradation study

1.OBJECTIVES :
Objective of this SOP is to provide the procedure for forced degradation of API and Pharmaceutical product.

2. SCOPE :
This SOP is applicable for the forced degradation of API and Pharmaceutical product at pharma dekho

3. RESPONSIBILITY :
QC Officer / Executive To prepare and executive the forced degradation
study protocol and prepare Forced Degradation study
report.
Head Quality Control To review the forced degradation study protocol and .
Forced degradation study report.
Head QA To approve the forced degradation study protocol and
Forced Degradation Study report & compliance of the
SOP.

4. ACCOUNTABILITY :
Quality Assurance Head and Quality Control Head shall be accountable for compliance of the procedure mentioned in the SOP.

5. DEFINITION :
Forced degradation : Forced degradation is also known as stress testing, uses artificial methods to force a drug to break down. It is a useful tool for predicting the stability of active pharmaceutical ingredients (API) or formulated products. Helps you learn about contaminants that occur when storing medicines in different environmental conditions.
According to the FDA, forced degradation studies are performed during the third step of drug substance or drug product submission. Degradation limits are 5-20%. Gradations greater than 20% are abnormal and should be investigated.
6.0 PROCEDURE : Forced degradation study depends upon the product and the type of dosage form. Solid, Oral liquid and injection dosage forms have procedure of the stress study.

6.1 Forced degradation studies are carried out to achieve the following purposes:
6.1.1 To establish degradation pathway of drug substances and drug products.
6.1.2 To differentiate degradation products that is related to drug products from those that are generated from non-drug product in a formulation.
6.1.3 To clarify the structure of degradation products.
6.1.4 To determine the Intrinbsic stability of a drug substances in formulation.
6.1.5 To reveal the degradation mechanism such as hydrolysis, oxidation, thermolysis
or photolysis of the drug substances and drug product.
6.1.6 To establish stability indicating nature of a developed method.
6.1.7 To understand the chemical properties of drug molecules.
6.1.8 To generate more stable formulations.
6.1.9 To solve stability-related problems.

6.2 TIME AND VARIOUS CONDITIONS TOOERFORMFORCED DEGRADATION
These Forced degradation studies are conducted on a single batch
• Hydrolysis
• Oxidation condition
• Photolytic condition
• Thermal condition

Conditions mostly used for forced degradation studies
1. Hydrolysis: Hydrolysis is a common degradation process due to the reaction of chemicals with water at various pH values. During forced degradation, the drug reacted
With water under acidic and basic conditions. The concentration of acid or base is selected depending on the stability of the active ingredient. Typically, 0.1-1.0 M HCL or H2SO4 (hydrochloric acid or sulfuric acid) is used to create acidic conditions, and 0.1-1.0 M NaOH or KOH (sodium hydroxide or potassium hydroxide) is used to create basic conditions. .

2. Oxidative degradation: H2O2 (hydrogen peroxide) is a commonly used oxidizing agent and is also used to study forced degradation.

3. Photolytic degradation: Photostability tests are conducted on each drug to determine the effect of light on the product during storage in the market. The stability guidelines for photostability describe the light conditions for photolysis. The light source should be a cool white fluorescent lamp and the light wavelength should be between 200 and 800 nm (UV+ visible). The exposure time should be at least 1 million lux hours and the light intensity should be at least 200 watt hours per square meter. Conditions should be monitored with a calibrated light meter.

4. Thermal decomposition: Temperature has a greater effect on drug substance stability than any other condition. Therefore, this is an important element and must be done carefully. Thermal degradation studies are performed between 40 and 80 °C

Abbreviation	Extended form
SOP	Standard Operating Procedure
QA	Quality Assurnace
QC	Quality Control
ICH	International Council for Hormonisation
API	Active Pharmaceutical Ingredient

Sop for force degradation study

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