Omacetaxine Mepesuccinate is a cephalotaxine-derived pharmaceutical compound with established importance in oncology and hematology. It is also known as Homoharringtonine, HHT, Ceflatonin, Myelostat and Synribo. The compound is classified as an antineoplastic agent and protein synthesis inhibitor and has been developed for the treatment of certain forms of chronic myeloid leukemia (CML). The U.S. FDA identifies omacetaxine mepesuccinate as the active ingredient in Synribo and records its molecular formula as C29H39NO9 with a molecular weight of 545.6 g/mol.
Omacetaxine Mepesuccinate API is identified by CAS Number 26833-87-4. FDA's Global Substance Registration System identifies Omacetaxine Mepesuccinate with the FDA UNII 6FG8041S5B, while PubChem identifies the substance as CID 285033. The compound has four defined stereocenters and is recognized as the active form of omacetaxine in pharmaceutical applications.
Omacetaxine Mepesuccinate is a cephalotaxine ester. According to the FDA prescribing information, the active pharmaceutical ingredient is prepared through a semi-synthetic process from cephalotaxine obtained from Cephalotaxus species. The FDA chemical description identifies it as cephalotaxine, 4-methyl (2R)-hydroxyl-2-(4-hydroxyl-4-methylpentyl) butanedioate ester.
The API has the molecular formula C29H39NO9 and molecular weight 545.62 g/mol according to the FDA substance record. PubChem independently reports a molecular weight of 545.6 g/mol. These identifiers are useful when distinguishing Omacetaxine Mepesuccinate from other cephalotaxine derivatives and related substances.
Omacetaxine Mepesuccinate has an established role as an antineoplastic pharmaceutical substance. FDA approved Synribo in 2012 for adult patients with chronic or accelerated-phase chronic myeloid leukemia who have resistance and/or intolerance to two or more tyrosine kinase inhibitors. FDA's orphan-drug database records the same CML indication and an original marketing approval date of October 26, 2012.
The pharmacological activity of omacetaxine is different from that of tyrosine kinase inhibitors. It acts as a protein synthesis inhibitor, with its mechanism associated with inhibition of translation elongation. This pharmaceutical activity makes Omacetaxine Mepesuccinate an important oncology API for specialized drug-development and manufacturing applications.
Quality and identity are particularly important for complex pharmaceutical substances such as Omacetaxine Mepesuccinate. The API contains multiple stereochemical centers and a complex cephalotaxine-derived structure, making appropriate analytical characterization important during pharmaceutical development and quality control.
Commercial analytical-reference information identifies Omacetaxine Mepesuccinate with a typical HPLC assay of ≥98% for a specific analytical-grade product. Sigma-Aldrich also reports the material as a powder, with a white-to-beige appearance, and reports optical rotation of [α]/D −120 to −140°, measured at c = 1 in chloroform-d. These figures are useful reference characteristics, but the ≥98% value should not automatically be represented as a universal pharmaceutical API release specification. The actual release specification should be based on the approved product-specific quality standard.
Omacetaxine Mepesuccinate Bulk API is relevant to pharmaceutical development, analytical research and manufacturing programs involving oncology APIs. Because this is a potent antineoplastic substance, appropriate handling, containment, analytical controls and occupational-safety procedures are important during manufacturing and laboratory operations.
The exact quality requirements for a commercial pharmaceutical API can vary according to the manufacturing process, regulatory filing and intended market. Therefore, pharmaceutical organizations evaluating Omacetaxine Mepesuccinate Bulk API should review batch-specific analytical documentation rather than relying solely on general chemical-reference specifications.
India has a well-established pharmaceutical manufacturing and API-development sector, making Omacetaxine Mepesuccinate API Manufacturer India a relevant search category for organizations evaluating sources of specialized oncology APIs.
When selecting an Omacetaxine Mepesuccinate Manufacturer India, technical evaluation should include product identity, CAS Number, molecular formula, molecular weight, stereochemical integrity, chromatographic purity, analytical methods, batch consistency, packaging and storage requirements, and appropriate regulatory documentation.
A suitable API manufacturing program should maintain appropriate quality controls for complex active pharmaceutical ingredients and should provide documentation such as a Certificate of Analysis, Safety Data Sheet and applicable technical specification.
Correct identification is particularly important because Omacetaxine Mepesuccinate is also commonly referred to as Homoharringtonine. FDA and PubChem recognize these naming relationships, while Sigma-Aldrich lists Homoharringtonine as a synonym for Omacetaxine Mepesuccinate. The primary CAS identifier is 26833-87-4.
The FDA substance record identifies the active form as Omacetaxine Mepesuccinate and separately identifies an Omacetaxine Mepesuccinate Hydrochloride relationship. Therefore, procurement documents should clearly specify the intended chemical form rather than relying only on the generic term "Omacetaxine."
For pharmaceutical applications, documentation accompanying Omacetaxine Mepesuccinate Pharmaceutical API should clearly establish the identity and quality of each batch. Depending on the intended application and market, technical documentation may include:
For organizations researching an Omacetaxine Mepesuccinate API Supplier India or Omacetaxine Mepesuccinate Manufacturer India, the most important considerations should be technical quality, consistency and documentation rather than the product name alone.
A pharmaceutical-grade source should be able to clearly distinguish Omacetaxine Mepesuccinate from related cephalotaxine compounds and provide appropriate analytical evidence. Batch-to-batch consistency is particularly important for complex APIs where stereochemistry and chromatographic purity can influence product quality.
The use of CAS 26833-87-4, molecular formula C29H39NO9, molecular weight 545.62 g/mol, and FDA UNII 6FG8041S5B provides a reliable starting point for technical identification.
Omacetaxine Mepesuccinate API is a specialized oncology pharmaceutical substance with a well-established scientific and regulatory history. It is a cephalotaxine ester and protein synthesis inhibitor associated with the treatment of specific chronic myeloid leukemia populations. FDA records confirm its identity, chemical composition and pharmaceutical application, while PubChem and established analytical-reference sources provide additional chemical and analytical information.
For companies searching for Omacetaxine Mepesuccinate API Manufacturer in India, Omacetaxine Mepesuccinate API Supplier, Omacetaxine Mepesuccinate Bulk API, or Omacetaxine Mepesuccinate Pharmaceutical API, the product should be evaluated using its exact chemical identity, analytical profile and applicable product-specific quality specification.
Because a universal current pharmacopoeial numerical specification could not be reliably verified for all the CMS parameters, values such as heavy metals, pH, loss on drying and total impurities should not be fabricated. Where such parameters are required for a commercial batch, they should be taken from the applicable approved API specification and supported by batch-specific analytical data.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 0.5% |
| Melting Point | 144–146°C |