What are the degradation products?
What are the degradation products?
Degradation products are unwanted chemicals that can develop during the manufacturing, transportation, and storage of drug products and can affect the efficacy of pharmaceutical products.
What is pharmacy degradation?
PHARMACEUTICAL DEGRADATION. The incapacity or incapability of a particular formulation in a specific container to remain within a particular chemical, microbiological, therapeutical, physical & toxicological specification.
What is stress study in pharmaceuticals?
Forced degradation is also known as stress testing and a drug is degraded forcefully by applying artificial methods. It is a useful tool to predict the stability of any Active Pharmaceutical Ingredient (API) or formulation product.
What is API degradation?
Sample generation. For generating samples for SIM the API is force degraded at conditions more severe than accelerated degradation conditions. It involves degradation of drug at hydrolytic, oxidative, photolytic and thermal conditions as discussed earlier.
Why is drug degradation important?
The degradation of a drug can generate sorption, crystal growth, crystallization, or even loss of water in a formulation. Similarly, the physical nature of excipients must also be kept under consideration during manufacturing and storage as excipients generally undergo chemical, microbial, and physical instability.
What is degradation study?
Forced degradation studies include the degradation of new drug substance and drug product at conditions more severe than accelerated conditions. These studies illustrate the chemical stability of the molecule which further facilitates the development of stable formulation with suitable storage conditions.
What is drug oxidation?
The main chemical reactions that affect the stability of a drug are oxidation and hydrolysis. Oxidation involves the removal of electrons from a molecule (or the addition of oxygen) and such reactions can be initiated by light, heat or certain trace metals.
Which of the followng is the cause of physical degradation of drugs?
Oxidation is one of the most common causes of drug degradation in pharmaceutical systems. Oxidative degradation often presents unique patterns of drug degradation (eg, rapid growth of impurities following an induction period and sensitivity to trace amounts of free radicals).
What does Ich mean?
ICH
| Acronym | Definition |
|---|---|
| ICH | Intangible Cultural Heritage |
| ICH | I/O Controller Hub |
| ICH | International Conference on Harmonization (US FDA) |
| ICH | International Conference on Harmonization (of Technical Requirements for Registration of Pharmaceuticals for Human Use) |
Why HCl is used in forced degradation?
It is customary to use 1N HCl and/or 1 N NaOH as degradants is FD studies because these are simple and ‘strong’ oxidizing/reducing reagents; furthermore, they are both mono-protic/hydroxyl and do not present additional side reactions that inhere with poly-ionic reagents.
What is hydrolysis in pharmacy?
Hydrolysis is the cleavage of a chemical species by water. Since water, either as a solvent or in the form of moisture in the air, contacts most pharmaceutical dosage forms to some degree, the potential for this degradation pathway exists for most drugs and excipients.
What is mass balance in pharmaceuticals?
Mass balance correlates the measured loss of a parent drug to the measured increase in the amount of degradation products. If the loss in potency can be reasonably accounted for by the amount of degradants measured, then mass balance is achieved.
Why do we need product degradation profiles for pharmaceuticals?
Drug product degradation profiles need to be established to guide stable formulation and provide suitable drug shelf life assessment. Drug regulatory agencies also have requirements for characterization of the impurity profile of a pharmaceutical.
What is the role of Forced degradation in drug development?
Forced degradation plays an important role in the drug development process. It furthers understanding of the chemistry of the drug substance and drug product and facilitates the development of stability indicating analytical methodology.
What are the degradation products observed in storage studies?
The degradation products observed in such studies are “potential” degradation products that may or may not be formed under relevant storage conditions, but these products reveal the degradation pathways available to the drug and facilitate the development of stability-indicating analytical methods.
What are forforced degradation studies?
Forced degradation studies are used to facilitate the development of analytical methodology, to gain a better understanding of active pharmaceutical ingredient (API) and drug product (DP) stability, and to provide information about degradation pathways and degradation products.
