Details
| Stereochemistry | ABSOLUTE |
| Molecular Formula | C10H13FN5O7P |
| Molecular Weight | 365.2117 |
| Optical Activity | UNSPECIFIED |
| Defined Stereocenters | 4 / 4 |
| E/Z Centers | 0 |
| Charge | 0 |
SHOW SMILES / InChI
SMILES
NC1=NC(F)=NC2=C1N=CN2[C@@H]3O[C@H](COP(O)(O)=O)[C@@H](O)[C@@H]3O
InChI
InChIKey=GIUYCYHIANZCFB-FJFJXFQQSA-N
InChI=1S/C10H13FN5O7P/c11-10-14-7(12)4-8(15-10)16(2-13-4)9-6(18)5(17)3(23-9)1-22-24(19,20)21/h2-3,5-6,9,17-18H,1H2,(H2,12,14,15)(H2,19,20,21)/t3-,5-,6+,9-/m1/s1
| Molecular Formula | C10H13FN5O7P |
| Molecular Weight | 365.2117 |
| Charge | 0 |
| Count |
|
| Stereochemistry | ABSOLUTE |
| Additional Stereochemistry | No |
| Defined Stereocenters | 4 / 4 |
| E/Z Centers | 0 |
| Optical Activity | UNSPECIFIED |
Fludarabine or fludarabine phosphate is a chemotherapy drug used in the treatment of hematological malignancies (cancers of blood cells such as leukemias and lymphomas). It is a purine analog, which interferes with DNA synthesis. Fludarabine phosphate is a fluorinated nucleotide analog of the antiviral agent vidarabine, 9-β-D-arabinofuranosyladenine (ara-A), that is relatively resistant to deamination by adenosine deaminase. Fludarabine (marketed as fludarabine phosphate under the trade name Fludara) is a chemotherapy drug used in the treatment of hematological malignancies. Fludarabine phosphate is rapidly dephosphorylated to 2-fluoro-ara-A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoro-ara-ATP. This metabolite appears to act by inhibiting DNA polymerase alpha, ribonucleotide reductase and DNA primase, thus inhibiting DNA synthesis. The mechanism of action of this antimetabolite is not completely characterized and may be multi-faceted.
CNS Activity
Approval Year
Targets
| Primary Target | Pharmacology | Condition | Potency |
|---|---|---|---|
Target ID: CHEMBL1828 |
|||
Target ID: CHEMBL1830 Sources: https://www.ncbi.nlm.nih.gov/pubmed/?term=23115527 |
Conditions
| Condition | Modality | Targets | Highest Phase | Product |
|---|---|---|---|---|
| Primary | FLUDARABINE PHOSPHATE Approved UseFludarabine Phosphate Injection is indicated for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL)
who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. The safety and effectiveness of Fludarabine Phosphate Injection in previously untreated or non-refractory patients with CLL have not been established. Important Limitations Fludarabine Phosphate Injection should not be used in patients with severe renal impairment (creatinine clearance less than 30 mL/min/1.73 m2). Launch Date2007 |
Cmax
| Value | Dose | Co-administered | Analyte | Population |
|---|---|---|---|---|
4.28 μM EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/17211431 |
30 mg/m² single, intravenous dose: 30 mg/m² route of administration: Intravenous experiment type: SINGLE co-administered: |
FLUDARABINE plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
AUC
| Value | Dose | Co-administered | Analyte | Population |
|---|---|---|---|---|
21.55 μM × h EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/17211431 |
30 mg/m² single, intravenous dose: 30 mg/m² route of administration: Intravenous experiment type: SINGLE co-administered: |
FLUDARABINE plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
T1/2
| Value | Dose | Co-administered | Analyte | Population |
|---|---|---|---|---|
20 h |
25 mg/m² 1 times / day multiple, intravenous dose: 25 mg/m² route of administration: Intravenous experiment type: MULTIPLE co-administered: |
FLUDARABINE plasma | Homo sapiens population: UNHEALTHY age: UNKNOWN sex: UNKNOWN food status: UNKNOWN |
|
8.9 h EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/17211431 |
30 mg/m² single, intravenous dose: 30 mg/m² route of administration: Intravenous experiment type: SINGLE co-administered: |
FLUDARABINE plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
Doses
| Dose | Population | Adverse events |
|---|---|---|
100 mg/m2 1 times / day multiple, intravenous Highest studied dose Dose: 100 mg/m2, 1 times / day Route: intravenous Route: multiple Dose: 100 mg/m2, 1 times / day Sources: |
unhealthy, 32 years (range: 19-59 years) Health Status: unhealthy Age Group: 32 years (range: 19-59 years) Sex: M+F Sources: |
Other AEs: Leukopenia... |
40 mg/m2 1 times / day steady, intravenous MTD Dose: 40 mg/m2, 1 times / day Route: intravenous Route: steady Dose: 40 mg/m2, 1 times / day Sources: |
unhealthy, 32 years (range: 19-59 years) Health Status: unhealthy Age Group: 32 years (range: 19-59 years) Sex: M+F Sources: |
|
20 mg/m2 1 times / day multiple, intravenous MTD Dose: 20 mg/m2, 1 times / day Route: intravenous Route: multiple Dose: 20 mg/m2, 1 times / day Sources: |
unhealthy, 55 years (range: 26-78 years) Health Status: unhealthy Age Group: 55 years (range: 26-78 years) Sex: M+F Sources: |
|
45 mg/m2 1 times / day multiple, intravenous Dose: 45 mg/m2, 1 times / day Route: intravenous Route: multiple Dose: 45 mg/m2, 1 times / day Sources: |
unhealthy, 55 years (range: 26-78 years) Health Status: unhealthy Age Group: 55 years (range: 26-78 years) Sex: M+F Sources: |
DLT: Myelosuppression... Dose limiting toxicities: Myelosuppression (1 patient) Sources: |
40 mg/m2 1 times / day steady, oral Recommended Dose: 40 mg/m2, 1 times / day Route: oral Route: steady Dose: 40 mg/m2, 1 times / day Sources: |
unhealthy, 64 years (range: 30-75 years) Health Status: unhealthy Age Group: 64 years (range: 30-75 years) Sex: M+F Sources: |
Disc. AE: Thrombocytopenia, Anemia hemolytic autoimmune... AEs leading to discontinuation/dose reduction: Thrombocytopenia (1 patient) Sources: Anemia hemolytic autoimmune (3 patients) Pneumonia (1 patient) Anemia (1 patient) Foot drop (1 patient) Sepsis (1 patient) Bronchitis (1 patient) Rash (1 patient) Face edema (1 patient) |
25 mg/m2 1 times / day steady, intravenous Recommended Dose: 25 mg/m2, 1 times / day Route: intravenous Route: steady Dose: 25 mg/m2, 1 times / day Sources: |
unhealthy, adult Health Status: unhealthy Age Group: adult Sources: |
Other AEs: CNS toxicity, Hemolytic anemia... Other AEs: CNS toxicity Sources: Hemolytic anemia Pulmonary toxicity |
40 mg/m2 1 times / day steady, oral Recommended Dose: 40 mg/m2, 1 times / day Route: oral Route: steady Dose: 40 mg/m2, 1 times / day Sources: |
unhealthy, adult Health Status: unhealthy Age Group: adult Sources: |
Other AEs: CNS toxicity, Hemolytic anemia... Other AEs: CNS toxicity Sources: Hemolytic anemia Pulmonary toxicity |
AEs
| AE | Significance | Dose | Population |
|---|---|---|---|
| Leukopenia | 2 patients | 100 mg/m2 1 times / day multiple, intravenous Highest studied dose Dose: 100 mg/m2, 1 times / day Route: intravenous Route: multiple Dose: 100 mg/m2, 1 times / day Sources: |
unhealthy, 32 years (range: 19-59 years) Health Status: unhealthy Age Group: 32 years (range: 19-59 years) Sex: M+F Sources: |
| Myelosuppression | 1 patient DLT, Disc. AE |
45 mg/m2 1 times / day multiple, intravenous Dose: 45 mg/m2, 1 times / day Route: intravenous Route: multiple Dose: 45 mg/m2, 1 times / day Sources: |
unhealthy, 55 years (range: 26-78 years) Health Status: unhealthy Age Group: 55 years (range: 26-78 years) Sex: M+F Sources: |
| Anemia | 1 patient Disc. AE |
40 mg/m2 1 times / day steady, oral Recommended Dose: 40 mg/m2, 1 times / day Route: oral Route: steady Dose: 40 mg/m2, 1 times / day Sources: |
unhealthy, 64 years (range: 30-75 years) Health Status: unhealthy Age Group: 64 years (range: 30-75 years) Sex: M+F Sources: |
| Bronchitis | 1 patient Disc. AE |
40 mg/m2 1 times / day steady, oral Recommended Dose: 40 mg/m2, 1 times / day Route: oral Route: steady Dose: 40 mg/m2, 1 times / day Sources: |
unhealthy, 64 years (range: 30-75 years) Health Status: unhealthy Age Group: 64 years (range: 30-75 years) Sex: M+F Sources: |
| Face edema | 1 patient Disc. AE |
40 mg/m2 1 times / day steady, oral Recommended Dose: 40 mg/m2, 1 times / day Route: oral Route: steady Dose: 40 mg/m2, 1 times / day Sources: |
unhealthy, 64 years (range: 30-75 years) Health Status: unhealthy Age Group: 64 years (range: 30-75 years) Sex: M+F Sources: |
| Foot drop | 1 patient Disc. AE |
40 mg/m2 1 times / day steady, oral Recommended Dose: 40 mg/m2, 1 times / day Route: oral Route: steady Dose: 40 mg/m2, 1 times / day Sources: |
unhealthy, 64 years (range: 30-75 years) Health Status: unhealthy Age Group: 64 years (range: 30-75 years) Sex: M+F Sources: |
| Pneumonia | 1 patient Disc. AE |
40 mg/m2 1 times / day steady, oral Recommended Dose: 40 mg/m2, 1 times / day Route: oral Route: steady Dose: 40 mg/m2, 1 times / day Sources: |
unhealthy, 64 years (range: 30-75 years) Health Status: unhealthy Age Group: 64 years (range: 30-75 years) Sex: M+F Sources: |
| Rash | 1 patient Disc. AE |
40 mg/m2 1 times / day steady, oral Recommended Dose: 40 mg/m2, 1 times / day Route: oral Route: steady Dose: 40 mg/m2, 1 times / day Sources: |
unhealthy, 64 years (range: 30-75 years) Health Status: unhealthy Age Group: 64 years (range: 30-75 years) Sex: M+F Sources: |
| Sepsis | 1 patient Disc. AE |
40 mg/m2 1 times / day steady, oral Recommended Dose: 40 mg/m2, 1 times / day Route: oral Route: steady Dose: 40 mg/m2, 1 times / day Sources: |
unhealthy, 64 years (range: 30-75 years) Health Status: unhealthy Age Group: 64 years (range: 30-75 years) Sex: M+F Sources: |
| Thrombocytopenia | 1 patient Disc. AE |
40 mg/m2 1 times / day steady, oral Recommended Dose: 40 mg/m2, 1 times / day Route: oral Route: steady Dose: 40 mg/m2, 1 times / day Sources: |
unhealthy, 64 years (range: 30-75 years) Health Status: unhealthy Age Group: 64 years (range: 30-75 years) Sex: M+F Sources: |
| Anemia hemolytic autoimmune | 3 patients Disc. AE |
40 mg/m2 1 times / day steady, oral Recommended Dose: 40 mg/m2, 1 times / day Route: oral Route: steady Dose: 40 mg/m2, 1 times / day Sources: |
unhealthy, 64 years (range: 30-75 years) Health Status: unhealthy Age Group: 64 years (range: 30-75 years) Sex: M+F Sources: |
| CNS toxicity | 25 mg/m2 1 times / day steady, intravenous Recommended Dose: 25 mg/m2, 1 times / day Route: intravenous Route: steady Dose: 25 mg/m2, 1 times / day Sources: |
unhealthy, adult Health Status: unhealthy Age Group: adult Sources: |
|
| Hemolytic anemia | 25 mg/m2 1 times / day steady, intravenous Recommended Dose: 25 mg/m2, 1 times / day Route: intravenous Route: steady Dose: 25 mg/m2, 1 times / day Sources: |
unhealthy, adult Health Status: unhealthy Age Group: adult Sources: |
|
| Pulmonary toxicity | 25 mg/m2 1 times / day steady, intravenous Recommended Dose: 25 mg/m2, 1 times / day Route: intravenous Route: steady Dose: 25 mg/m2, 1 times / day Sources: |
unhealthy, adult Health Status: unhealthy Age Group: adult Sources: |
|
| CNS toxicity | 40 mg/m2 1 times / day steady, oral Recommended Dose: 40 mg/m2, 1 times / day Route: oral Route: steady Dose: 40 mg/m2, 1 times / day Sources: |
unhealthy, adult Health Status: unhealthy Age Group: adult Sources: |
|
| Hemolytic anemia | 40 mg/m2 1 times / day steady, oral Recommended Dose: 40 mg/m2, 1 times / day Route: oral Route: steady Dose: 40 mg/m2, 1 times / day Sources: |
unhealthy, adult Health Status: unhealthy Age Group: adult Sources: |
|
| Pulmonary toxicity | 40 mg/m2 1 times / day steady, oral Recommended Dose: 40 mg/m2, 1 times / day Route: oral Route: steady Dose: 40 mg/m2, 1 times / day Sources: |
unhealthy, adult Health Status: unhealthy Age Group: adult Sources: |
Overview
| CYP3A4 | CYP2C9 | CYP2D6 | hERG |
|---|---|---|---|
OverviewOther
| Other Inhibitor | Other Substrate | Other Inducer |
|---|---|---|
Drug as perpetrator
Drug as victim
| Target | Modality | Activity | Metabolite | Clinical evidence |
|---|---|---|---|---|
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022273s000_ClinPharmR.pdf#page=41 Page: 41.0 |
no | |||
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022273s000_ClinPharmR.pdf#page=41 Page: 41.0 |
no | |||
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022273s000_ClinPharmR.pdf#page=27 Page: 27.0 |
weak |
PubMed
| Title | Date | PubMed |
|---|---|---|
| Systems pharmacological analysis of drugs inducing stevens-johnson syndrome and toxic epidermal necrolysis. | 2015-05-18 |
|
| Inhibitory effect of leptin on rosiglitazone-induced differentiation of primary adipocytes prepared from TallyHO/Jng mice. | 2011-03-25 |
|
| The synergistic cytotoxicity of clofarabine, fludarabine and busulfan in AML cells involves ATM pathway activation and chromatin remodeling. | 2011-01-15 |
|
| Hypomethylation and induction of retinoic acid receptor beta 2 by concurrent action of adenosine analogues and natural compounds in breast cancer cells. | 2010-07-25 |
|
| Use of clofarabine for acute childhood leukemia. | 2010-06-24 |
|
| Incidence and susceptibility to therapy-related myeloid neoplasms. | 2010-03-19 |
|
| ARC (NSC 188491) has identical activity to Sangivamycin (NSC 65346) including inhibition of both P-TEFb and PKC. | 2009-02-20 |
|
| Fludarabine in the treatment of chronic lymphocytic leukemia: a review. | 2009-02 |
|
| Valproate synergizes with purine nucleoside analogues to induce apoptosis of B-chronic lymphocytic leukaemia cells. | 2009-01 |
|
| Oral fludarabine and cyclophosphamide as front-line chemotherapy in patients with chronic lymphocytic leukemia. The impact of biological parameters in the response duration. | 2008-11 |
|
| Fatal acute liver failure due to reactivation of hepatitis B following treatment with fludarabine/cyclophosphamide/rituximab for low grade non-Hodgkin's lymphoma. | 2008-10-27 |
|
| Role of histone deacetylase inhibitor-induced reactive oxygen species and DNA damage in LAQ-824/fludarabine antileukemic interactions. | 2008-10 |
|
| Treosulfan/fludarabine as an allogeneic hematopoietic stem cell transplant conditioning regimen for high-risk patients. | 2008-09 |
|
| Differential effects of chemotherapeutic drugs versus the MDM-2 antagonist nutlin-3 on cell cycle progression and induction of apoptosis in SKW6.4 lymphoblastoid B-cells. | 2008-05-15 |
|
| Prodrug converting enzyme gene delivery by L. monocytogenes. | 2008-04-10 |
|
| Resveratrol exerts antiproliferative activity and induces apoptosis in Waldenström's macroglobulinemia. | 2008-03-15 |
|
| Targeting lipid metabolism by the lipoprotein lipase inhibitor orlistat results in apoptosis of B-cell chronic lymphocytic leukemia cells. | 2008-03 |
|
| Fludarabine, cyclophosphamide, and mitoxantrone as initial therapy of chronic lymphocytic leukemia: high response rate and disease eradication. | 2008-01-01 |
|
| Assessment of fludarabine plus cyclophosphamide for patients with chronic lymphocytic leukaemia (the LRF CLL4 Trial): a randomised controlled trial. | 2007-07-21 |
|
| Drug resistance in B-cell chronic lymphocytic leukemia: predictable by in vitro evaluation with a multiparameter flow cytometric cytotoxicity assay. | 2007-05 |
|
| Randomized phase III trial of fludarabine plus cyclophosphamide with or without oblimersen sodium (Bcl-2 antisense) in patients with relapsed or refractory chronic lymphocytic leukemia. | 2007-03-20 |
|
| Fatal leukoencephalopathy after reduced-intensity allogeneic stem cell transplantation. | 2007-02 |
|
| Myelopathy due to intrathecal chemotherapy: magnetic resonance imaging findings. | 2007-02 |
|
| Cutaneous recall phenomenon at the site of previous doxorubicin extravasation after second-line chemotherapy. | 2007-01-17 |
|
| STAT1 signaling is associated with acquired crossresistance to doxorubicin and radiation in myeloma cell lines. | 2007-01-01 |
|
| [Prognostic significance of immunoglobulin variable region gene mutations in B-CLL patients treated with combination therapy fludarabine plus cyclophosphamide]. | 2007 |
|
| Characterization of the rat Na+/nucleoside cotransporter 2 and transport of nucleoside-derived drugs using electrophysiological methods. | 2006-12 |
|
| Role of fludarabine in hematological malignancies. | 2006-09 |
|
| MDM2 antagonists activate p53 and synergize with genotoxic drugs in B-cell chronic lymphocytic leukemia cells. | 2006-05-15 |
|
| Functional integrity of the p53-mediated apoptotic pathway induced by the nongenotoxic agent nutlin-3 in B-cell chronic lymphocytic leukemia (B-CLL). | 2006-05-15 |
|
| Chronic lymphocytic leukaemia, synchronous small cell carcinoma and squamous neoplasia of the urinary bladder in a paraplegic man following long-term phenoxybenzamine therapy. | 2006-03 |
|
| Phase I and pharmacokinetic study of oral fludarabine phosphate in relapsed indolent B-cell non-Hodgkin's lymphoma. | 2006-02 |
|
| Alteration of DNA methylation status in K562 and MCF-7 cancer cell lines by nucleoside analogues. | 2006 |
|
| Recurrent chemotherapy-induced tumor lysis syndrome (TLS) with renal failure in a patient with chronic lymphocytic leukemia - successful treatment and prevention of TLS with low-dose rasburicase. | 2005-12 |
|
| A highly sensitive high-performance liquid chromatography-mass spectrometry method for quantification of fludarabine triphosphate in leukemic cells. | 2005-06-25 |
|
| Inhibition of the PI3K pathway sensitizes fludarabine-induced apoptosis in human leukemic cells through an inactivation of MAPK-dependent pathway. | 2005-06-03 |
|
| Resistance to 9-beta-D-arabinofuranosyl-2-fluoroadenine due to reduced incorporation into DNA from competition by excess deoxyadenosine triphosphate: implications for different sensitivities to nucleoside analogues. | 2005-06 |
|
| Functional characterization of novel human and mouse equilibrative nucleoside transporters (hENT3 and mENT3) located in intracellular membranes. | 2005-04-22 |
|
| Adenine deoxynucleotides fludarabine and cladribine induce apoptosis in a CD95/Fas receptor, FADD and caspase-8-independent manner by activation of the mitochondrial cell death pathway. | 2004-12-16 |
|
| Inhibition of repair of carboplatin-induced DNA damage by 9-beta-D-arabinofuranosyl-2-fluoroadenine in quiescent human lymphocytes. | 2004-11-01 |
|
| A phase I and pharmacodynamic study of fludarabine, carboplatin, and topotecan in patients with relapsed, refractory, or high-risk acute leukemia. | 2004-10-15 |
|
| Fatal peripheral neuropathy following FLA chemotherapy. | 2004-08 |
|
| 9-beta-D-arabinofuranosyl-2-fluoroadenine inhibits expression of vascular endothelial growth factor through hypoxia-inducible factor-1 in human ovarian cancer cells. | 2004-07 |
|
| Resistance to gemcitabine in a human follicular lymphoma cell line is due to partial deletion of the deoxycytidine kinase gene. | 2004-05-24 |
|
| Increased p21/WAF-1 and p53 protein levels following sequential three drug combination regimen of fludarabine, cytarabine and docetaxel induces apoptosis in human leukemia cells. | 1998-08-15 |
|
| Apoptosis induction with three nucleoside analogs on freshly isolated B-chronic lymphocytic leukemia cells. | 1994-12 |
|
| Fludarabine + Ara-C + G-CSF: cytotoxic effect and induction of apoptosis on fresh acute myeloid leukemia cells. | 1994-12 |
|
| Neurotoxicity associated with fludarabine and cytosine arabinoside chemotherapy for acute leukemia and myelodysplasia. | 1993-03 |
|
| Fludarabine and arabinosylcytosine therapy of refractory and relapsed acute myelogenous leukemia. | 1993-03 |
|
| In vitro biological activity of 9-beta-D-arabinofuranosyl-2-fluoroadenine and the biochemical actions of its triphosphate on DNA polymerases and ribonucleotide reductase from HeLa cells. | 1982-03 |
Sample Use Guides
Chronic Lymphocytic Leukemia (CLL): The recommended adult dose is 25 mg/m2 administered intravenously over a period of approximately 30 minutes daily for five consecutive days. Each 5-day course of treatment should commence every 28 days.
Route of Administration:
Intravenous
In Vitro Use Guide
Sources: https://www.ncbi.nlm.nih.gov/pubmed/21223714
The growth of RPMI8226 and KM3 cells was suppressed by fludarabine treatment in a dose and time-dependent manner. After treatment with fludarabine for 24 h, the IC(50) for RPMI8226 cells was 2.13 µg/ml, and 0.36 µg/ml for KM3 cells. Apoptotic cells of RPMI8226 and KM3 increased in a dose- dependent manner after exposure to fludarabine for 24 h. Western blot analysis showed the activation of caspase-3 and PARP in the MM cells treated with fludarabine.
| Substance Class |
Chemical
Created
by
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on
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Mon Mar 31 17:57:49 GMT 2025
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Mon Mar 31 17:57:49 GMT 2025
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| Record UNII |
1X9VK9O1SC
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| Record Status |
Validated (UNII)
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| Record Version |
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| Classification Tree | Code System | Code | ||
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NCI_THESAURUS |
C1556
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FDA ORPHAN DRUG |
35889
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FDA ORPHAN DRUG |
250607
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FDA ORPHAN DRUG |
27688
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NCI_THESAURUS |
C2150
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DB01073
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SUB13897MIG
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1X9VK9O1SC
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m5427
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25102
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75607-67-9
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C1102
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312887
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1X9VK9O1SC
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30751
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328002
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T-29
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DTXSID2023060
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100000090025
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CHEMBL1096882
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1189
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63599
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1272204
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BASIS OF STRENGTH->SUBSTANCE |
ASSAY (HPLC)
USP
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BASIS OF STRENGTH->SUBSTANCE |
ASSAY (HPLC)
EP
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| Related Record | Type | Details | ||
|---|---|---|---|---|
|
METABOLITE ACTIVE -> PRODRUG |
|
| Related Record | Type | Details | ||
|---|---|---|---|---|
|
IMPURITY -> PARENT |
For the calculation of contents, multiply the peak areas by 1.8
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
|
||
|
IMPURITY -> PARENT |
For the calculation of contents, multiply the peak areas by 2.5
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
|
||
|
IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
|
||
|
IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
|
||
|
IMPURITY -> PARENT |
For the calculation of contents, multiply the peak areas by 0.5
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
|
||
|
IMPURITY -> PARENT |
For the calculation of contents, multiply the peak areas by 1.9
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
|
||
|
IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
|
||
|
IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
|
||
|
IMPURITY -> PARENT |
For the calculation of contents, multiply the peak areas by 0.6
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
|
||
|
IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
|
||
|
IMPURITY -> PARENT |
For the calculation of contents, multiply the peak areas by 4.0
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
|
||
|
IMPURITY -> PARENT |
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
|
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ACTIVE MOIETY |
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