Glatiramer Acetate is a synthetic polypeptide immunomodulator used in the treatment of relapsing forms of multiple sclerosis. It is composed of synthetic polypeptide chains containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine and L-lysine.
Unlike conventional small-molecule APIs, Glatiramer Acetate is a heterogeneous mixture of polypeptides with variable amino-acid sequences and molecular sizes. Therefore, its characterization requires specialized biological and physicochemical analytical methods.
Glatiramer Acetate is a specialized polypeptide pharmaceutical API used for injectable formulations. Its manufacturing requires controlled peptide/polypeptide synthesis, purification and extensive characterization to control composition, molecular-weight distribution, peptide-related impurities and biological activity.
CAS Number: 147245-92-9
Molecular Formula: Variable / heterogeneous polypeptide
Molecular Weight: Variable; approximately 5,000–9,000 Da
Drug Class: Immunomodulator
Therapeutic Class: Multiple Sclerosis Therapy
Therapeutic Area: Neurology / Immunology
Molecule Type: Synthetic Polypeptide
Salt Form: Acetate
The exact mechanism by which Glatiramer Acetate produces its therapeutic effect in multiple sclerosis is not completely established. It is believed to modify immune responses involving T lymphocytes and promote anti-inflammatory immune activity. Glatiramer Acetate can interact with major histocompatibility complex molecules and influence antigen-specific immune responses.
Glatiramer Acetate is indicated for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease in applicable approved labeling.
Glatiramer Acetate is administered by subcutaneous injection and is intended for long-term disease-modifying treatment. Its immunomodulatory properties help reduce the frequency of relapses in patients with relapsing forms of multiple sclerosis.
Glatiramer Acetate is not a single molecular entity. It consists of synthetic polypeptide chains containing glutamic acid, alanine, tyrosine and lysine in defined approximate molar proportions. Because of its heterogeneous nature, conventional molecular formula and exact molecular weight cannot be represented as a single fixed value.
Glatiramer Acetate API quality evaluation may include:
Glatiramer Acetate should be stored under controlled pharmaceutical conditions and protected from excessive heat, moisture and direct light. Exact storage conditions should be based on validated stability data and the applicable product-specific specification.
Glatiramer Acetate is an established immunomodulatory polypeptide used in multiple sclerosis research and pharmaceutical development. Its heterogeneous molecular structure makes comprehensive analytical characterization particularly important during manufacturing and quality control.
Glatiramer Acetate is a synthetic polypeptide immunomodulator composed of glutamic acid, alanine, tyrosine and lysine residues. It is identified by CAS Number 147245-92-9 and is primarily used for the treatment of relapsing forms of multiple sclerosis. Because it is a heterogeneous polypeptide mixture, its molecular weight and molecular formula are variable rather than fixed.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | ≤8.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 5.0 – 7.0 |
| Water Content | ≤8.0% |