Peptides: These are naturally occurring biological molecules. peptides are made up of smaller molecular sequence of amino acids. When a molecule consists of 2 to 50 amino acids it is called a peptide. They are classified by the number of amino acid components in the sequence, called amino acid residues. Tripeptides have three amino acid residues while tetrapeptides have four. A polypeptide is formed when the chain of amino acid links exceeds several dozen in length. Types of peptides depending on the number of amino acids they are characterized as: Polypeptides and Oligopeptides

1. Peptides and Probable Degradation Pathways
Peptides:
These are naturally occurring biological molecules. peptides are made up of smaller
molecular sequence of amino acids. When a molecule consists of 2 to 50 amino acids it is
called a peptide. They are classified by the number of amino acid components in the

2. sequence, called amino acid residues. Tripeptides have three amino acid residues while
tetrapeptides have four. A polypeptide is formed when the chain of amino acid links exceeds
several dozen in length.
Types of peptides depending on the number of amino acids they are characterized as:
Polypeptides and Oligopeptides
What are Peptides:
Peptides are naturally occurring biologics around 20 naturally occurring amino acids.
Peptides are safer than synthetic drugs and have a better efficacy, selectivity and specificity.
Peptides can join into an enormous multiplicity of dissimilar molecules and they can have
several advantages over small molecule drugs.
Peptides possess bioactivities, peptide breakdowns into amino acids and manage utmost
biological evolutions. Peptides are degrading into their constituent proteinogenic amino acids
without generating toxic metabolites. Due to peptides impermanent nature it makes an
expensive drug hence it was less accumulating in the body. Parenteral route is the most
effective mode of efficient delivery of peptides. Peptides frequently act as hormones and
biologic messengers carrying information through the blood from one to another tissue.
Degradation Pathways:
To avoid the degradation of peptides it is recommended that the peptide in lyophilized form
stored below 5°C or if possible, at – 20°C or – 80 °C and solution must be refrigerated. Long
term exposure to pH more than 8 and exposer to the atmospheric oxygen must be avoided.
Peptides stored in a lyophilized form is most stable than in solution state. Degradation of
peptides observed is classifieds into physical and chemical form is as per below:
A. Physical Degradation: It involves the weak sharing of an electron pair between a hydrogen
atom and another atom. It involves more dispersed variations of electromagnetic
interaction between molecules or within a molecule changes in non-covalent interaction.
Following are the physical degradation mechanism observed:
i. Denaturation
ii. Adsorption
iii. Aggregation
iv. Precipitation
v. Hydrophobic association/bonding
B. Chemical Degradation: It involves the sharing of an electron pair between two atoms are
the strongest. Number of impurities were observed due to raw materials, manufacturing
process, storage. Following are the chemical degradation mechanism observed:

3. i. Oxidation
ii. Hydrolysis
iii. Racemisation
iv. Deamidation (Gln/Asn/C-terminus)
v. Diketopiperazine and pyroglutamic acid formation
vi. Disulphide formation/exchange
vii. β-Elimination
Peptides drugs degradation products detected and characterized by the use of systematic or
complex analytical methods.
Conclusion:
Peptides based drug products are important remedies expected to substitute several present
chemical based formulations. Peptide drugs will be produced on a large scale by
biotechnology processes. Physical and chemical stability of peptide-based products is
challenging.
References:
1. FDA Guidance for Industry: ANDAs for certain Highly Purified Synthetic Peptide
Drug Products That Refer to Listed Drugs of rDNA Origin 1.
2. ICH, Q6A, Specifications: New Chemical Drug Substances and Products,
3. ICH, Q6B, Specifications Test Procedures and Acceptance Criteria for
Biotechnological/Biological Products,
4. ICH, Q5C, Stability Testing of Biotechnological/Biological Products,
5. ICH, Q1A(R2), Stability Testing of New Drug Substances and Products,
6. EMEA, Guideline on Stability Testing: Stability Testing of Existing Active
Substances and Related Finished Products,
7. L. Wu , F. Chen , S. L. Lee , A. Raw and L. X. Yu , Building Parity between Brand
and Generic Peptides: Regulatory and Scientific Considerations for Quality of
Synthetic Peptides, Int. J. Pharm.,
8. M. P. C. Ratnaparkhi and S. P. Pandya , Peptides and Proteins in Pharmaceuticals, Int.
J. Curr. Pharm. Res.,
9. To know more about Impurities and Pharmaceutical Drug substance read our blogs or
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