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Details

Stereochemistry RACEMIC
Molecular Formula C18H19N3O.ClH.2H2O
Molecular Weight 365.854
Optical Activity ( + / - )
Defined Stereocenters 0 / 1
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of ONDANSETRON HYDROCHLORIDE

SMILES

O.O.Cl.CN1C2=C(C3=C1C=CC=C3)C(=O)C(CN4C=CN=C4C)CC2

InChI

InChIKey=VRSLTNZJOUZKLX-UHFFFAOYSA-N
InChI=1S/C18H19N3O.ClH.2H2O/c1-12-19-9-10-21(12)11-13-7-8-16-17(18(13)22)14-5-3-4-6-15(14)20(16)2;;;/h3-6,9-10,13H,7-8,11H2,1-2H3;1H;2*1H2

HIDE SMILES / InChI

Molecular Formula H2O
Molecular Weight 18.0153
Charge 0
Count
Stereochemistry ACHIRAL
Additional Stereochemistry No
Defined Stereocenters 0 / 0
E/Z Centers 0
Optical Activity NONE

Molecular Formula C18H19N3O
Molecular Weight 293.363
Charge 0
Count
Stereochemistry RACEMIC
Additional Stereochemistry No
Defined Stereocenters 0 / 1
E/Z Centers 0
Optical Activity ( + / - )

Molecular Formula ClH
Molecular Weight 36.461
Charge 0
Count
Stereochemistry ACHIRAL
Additional Stereochemistry No
Defined Stereocenters 0 / 0
E/Z Centers 0
Optical Activity NONE

Description
Curator's Comment: description was created based on several sources, including https://www.ncbi.nlm.nih.gov/mesh/68017294 | https://www.ncbi.nlm.nih.gov/pubmed/11474424

Ondansetron (ZOFRAN®) is a selective 5-HT3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by radiotherapy, anesthesia, surgery or cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties. While its mechanism of action has not been fully characterized, ondansetron is not a dopamine-receptor antagonist. It is not certain whether ondansetron's antiemetic action is mediated centrally, peripherally, or in both sites. However, cytotoxic chemotherapy appears to be associated with release of serotonin from the enterochromaffin cells of the small intestine. The released serotonin may stimulate the vagal afferents through the 5-HT3 receptors and initiate the vomiting reflex.

Originator

Curator's Comment: Glaxo Wellcome is a predecessor of GlaxoSmithKline plc.

Approval Year

Targets

Targets

Primary TargetPharmacologyConditionPotency
8.31 null [pKi]
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Preventing
ZOFRAN

Approved Use

Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ZOFRAN® is recommended even where the incidence of postoperative nausea and/or vomiting is low.

Launch Date

7.2567357E11
Preventing
ZOFRAN

Approved Use

Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ZOFRAN® is recommended even where the incidence of postoperative nausea and/or vomiting is low.

Launch Date

7.2567357E11
Preventing
ZOFRAN

Approved Use

Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥50 mg/m2. Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ZOFRAN® is recommended even where the incidence of postoperative nausea and/or vomiting is low.

Launch Date

7.2567357E11
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
125.8 ng/mL
24 mg single, oral
dose: 24 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ONDANSETRON plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
194.4 ng/mL
24 mg single, oral
dose: 24 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ONDANSETRON plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE
food status: UNKNOWN
26.2 ng/mL
8 mg single, oral
dose: 8 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ONDANSETRON plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
42.7 ng/mL
8 mg single, oral
dose: 8 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ONDANSETRON plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE
food status: UNKNOWN
30.196 ng/mL
8 mg single, oral
dose: 8 mg
route of administration: oral
experiment type: single
co-administered:
ONDANSETRON plasma
Homo sapiens
32.096 ng/mL
8 mg single, oral
dose: 8 mg
route of administration: oral
experiment type: single
co-administered:
ONDANSETRON plasma
Homo sapiens
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
224.155 ng*h/mL
8 mg single, oral
dose: 8 mg
route of administration: oral
experiment type: single
co-administered:
ONDANSETRON plasma
Homo sapiens
270.927999999999 ng*h/mL
8 mg single, oral
dose: 8 mg
route of administration: oral
experiment type: single
co-administered:
ONDANSETRON plasma
Homo sapiens
237.935 ng*h/mL
8 mg single, oral
dose: 8 mg
route of administration: oral
experiment type: single
co-administered:
ONDANSETRON plasma
Homo sapiens
293.491999999999 ng*h/mL
8 mg single, oral
dose: 8 mg
route of administration: oral
experiment type: single
co-administered:
ONDANSETRON plasma
Homo sapiens
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
4.7 h
24 mg single, oral
dose: 24 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ONDANSETRON plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
5.8 h
24 mg single, oral
dose: 24 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ONDANSETRON plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE
food status: UNKNOWN
3.1 h
8 mg single, oral
dose: 8 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ONDANSETRON plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
3.5 h
8 mg single, oral
dose: 8 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ONDANSETRON plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: FEMALE
food status: UNKNOWN
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
27%
8 mg single, oral
dose: 8 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
ONDANSETRON plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: UNKNOWN
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG



OverviewOther

Other InhibitorOther SubstrateOther Inducer








Drug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
no [IC50 >100 uM]
yes [IC50 0.15 uM]
yes (co-administration study)
Comment: [PMID:23241029]: IC50 = 0.3 uM; Ondansetron treatment caused a statistically significantly higher Cmax of metformin compared with placebo and apparently decreased the renal clearance of metformin by 37%
yes [IC50 0.89 uM]
yes [IC50 17.4 uM]
yes [IC50 6.9 uM]
yes (co-administration study)
Comment: [PMID:23241029]: IC50 = 0.16 uM; Ondansetron treatment caused a statistically significantly higher Cmax of metformin compared with placebo and apparently decreased the renal clearance of metformin by 37%
Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
yes
yes
yes
likely (co-administration study)
Comment: inducers or inhibitors of CYP1A2 may change the clearance and, hence, the half-life of ondansetron
yes
likely (co-administration study)
yes
yes (co-administration study)
Comment: In patients treated with potent inducers of CYP3A4 (i.e., phenytoin, carbamazepine, and rifampin), the clearance of ondansetron was significantly increased and ondansetron blood concentrations were decreased. However, on the basis of available data, no dosage adjustment for ZOFRAN is recommended for patients on these drugs.
Tox targets

Tox targets

TargetModalityActivityMetaboliteClinical evidence
Sourcing

Sourcing

Vendor/AggregatorIDURL
PubMed

PubMed

TitleDatePubMed
Effects of the 5-HT3 receptor antagonist, GR38032F, on raised dopaminergic activity in the mesolimbic system of the rat and marmoset brain.
1987 Dec
Progress in the control of acute and delayed emesis induced by cisplatin.
1991
The efficacy of prophylactic ondansetron, droperidol, perphenazine, and metoclopramide in the prevention of nausea and vomiting after major gynecologic surgery.
1995 Jul
Inhibitory effect of ethanol on the 5-hydroxytryptamine-induced Bezold-Jarisch reflex--involvement of peripheral 5-HT3 receptors.
1995 May 26
Acute chorea due to ondansetron in an obstetric patient.
2001 Oct
Ondansetron in prophylaxis of postoperative nausea and vomiting in patients undergoing breast surgery: a placebo-controlled double blind study.
2004 Feb
Dystonic reaction following anaesthesia.
2004 Jul
Involvement of some 5-HT receptors in methamphetamine-induced locomotor activity in mice.
2004 Jun
Central nervous system side-effects of 5-HT3-receptor antagonists in elderly cancer patients treated with chemotherapy.
2004 Jun
Evaluation of fresh and cryopreserved hepatocytes as in vitro drug metabolism tools for the prediction of metabolic clearance.
2004 Nov
Role of central 5-HT3 receptors in the control of blood pressure in stressed and non-stressed rats.
2004 Nov 26
Ondansetron, given during the acute cocaine withdrawal, attenuates oral cocaine self-administration.
2004 Oct 25
Ondansetron amelioration of scopolamine induced cognitive deficits in three-panel runway apparatus in rats.
2004 Sep
Selective serotonin 5-HT3 receptor antagonists for postoperative nausea and vomiting: are they all the same?
2005
Efficacy and tolerability of oxaliplatin plus irinotecan 5-fluouracil and leucovorin regimen in advanced stage colorectal cancer patients pretreated with irinotecan 5-fluouracil and leucovorin.
2005 Dec
The effectiveness of rescue antiemetics after failure of prophylaxis with ondansetron or droperidol: a preliminary report.
2005 Feb
Non-paracetamol drug-induced fulminant hepatic failure among adults in Scotland.
2005 Feb
WIN 55,212-2-induced reduction of cocaine hyperlocomotion: possible inhibition of 5-HT(3) receptor function.
2005 Jul 4
A randomized, controlled crossover trial of ondansetron in patients with primary biliary cirrhosis and fatigue.
2005 Jun
Prolongation of QTc interval after postoperative nausea and vomiting treatment by droperidol or ondansetron.
2005 Jun
Ondansetron-induced extrapyramidal symptoms during cesarean section.
2005 Oct
Transient blindness following intravenous ondansetron.
2005 Sep
Antiemetic-related dystonic reaction unmasked by removal of a scopolamine transdermal patch.
2006 Apr
Monoaminergic neurotransmission is altered in hepatitis C virus infected patients with chronic fatigue and cognitive impairment.
2006 Nov
Interaction between tramadol and two anti-emetics on nociception and gastrointestinal transit in mice.
2006 Oct
A preliminary randomized, double-blind, placebo-controlled study of the safety and efficacy of ondansetron in the treatment of cocaine dependence.
2006 Oct 1
Can dantrolene contribute to methotrexate toxicity?
2006 Sep
Antiemetic neurokinin-1 antagonist aprepitant and ifosfamide-induced encephalopathy.
2007 Apr
Chronic fluoxetine treatment increases the expression of PSA-NCAM in the medial prefrontal cortex.
2007 Apr
The influence of dexamethasone in the decrease of chemotherapy-induced nausea and vomiting.
2007 Apr-Jun
Tropisetron, ondansetron, and granisetron for control of chemotherapy-induced emesis in Turkish cancer patients: a comparison of efficacy, side-effect profile, and cost.
2007 Apr-May
Comparison of the effectiveness of metoclopramide, ondansetron, and granisetron on the prevention of nausea and vomiting after laparoscopic cholecystectomy.
2007 Dec
Reversal of cocaine-induced behavioral sensitization and associated phosphorylation of the NR2B and GluR1 subunits of the NMDA and AMPA receptors.
2007 Feb
Interactions between metoclopramide and morphine: enhanced antinociception and motor dysfunction in rats.
2007 Jan-Feb
Spinal NK-1 receptor expressing neurons mediate opioid-induced hyperalgesia and antinociceptive tolerance via activation of descending pathways.
2007 May
Droperidol and ondansetron-induced QT interval prolongation: a clinical drug interaction study.
2008 Aug
Comparative efficacy of maropitant and selected drugs in preventing emesis induced by centrally or peripherally acting emetogens in dogs.
2008 Dec
Ondansetron-associated hypokalemia in a 2-year-old with pre-B-cell ALL.
2008 Jan
Ondansetron and carpopedal spasm.
2008 Jan
Coronary spasm after injection of ondansetron: case report and review of the literature.
2008 Jan 24
Ondansetron given intravenously attenuates arterial blood pressure drop due to spinal anesthesia: a double-blind, placebo-controlled study.
2008 Jul-Aug
Neonatal extrapyramidal movements. Neonatal withdrawal due to maternal citalopram and ondansetron use.
2008 Mar
A within-group design of nontreatment seeking 5-HTTLPR genotyped alcohol-dependent subjects receiving ondansetron and sertraline.
2009 Feb
Coronary vasospasm and atrial fibrillation associated with ondansetron therapy.
2009 Mar
Ondansetron-induced headache in a parturient mimicking postdural puncture headache.
2010 Feb
Clinical trial: oral ondansetron for reducing vomiting secondary to acute gastroenteritis in children--a double-blind randomized study.
2010 Jan
Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with cisplatin therapy: randomized, double-blind study protocol--EASE.
2011 Apr 10
In vivo assessment of antiemetic drugs and mechanism of lycorine-induced nausea and emesis.
2011 Dec
Profiling of a prescription drug library for potential renal drug-drug interactions mediated by the organic cation transporter 2.
2011 Jul 14
Differential time course of action of 5-HT3 and NK1 receptor antagonists when used with highly and moderately emetogenic chemotherapy (HEC and MEC).
2011 Sep
Patents

Sample Use Guides

To prevent nausea and vomiting associated with cancer chemotherapy the recommended adult oral dosage of ondansetron (ZOFRAN®) is a single 24-mg tablet administered 30 minutes before the start of single-day highly emetogenic chemotherapy; for moderately emetogenic cancer chemotherapy the recommended adult oral dosage is one 8-mg ondansetron (ZOFRAN®) tablet given twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy: the first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. To prevent nausea and vomiting associated with radiotherapy the recommended adult oral dosage is one 8-mg ondansetron (ZOFRAN®) tablet given 3 times a day; for total body irradiation, one 8-mg ondansetron (ZOFRAN®) tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day; for single high-dose fraction radiotherapy to the abdomen, one 8-mg ondansetron (ZOFRAN®) tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy; for daily fractionated radiotherapy to the abdomen, one 8-mg ondansetron (ZOFRAN®) tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given. To prevent postoperative nausea and vomiting the recommended adult oral dosage is 16 mg given as two 8-mg ondansetron (ZOFRAN®) tablets 1 hour before induction of anesthesia.
Route of Administration: Oral
In Vitro Use Guide
On the isolated vagus nerve and superior cervical ganglion of the rat, R,S-GR38032F (ondansetron) behaved as a reversible competitive antagonist of 5-HT-induced depolarization with pKB values of 8.61+/-0.08 (n=19) and 8.13+/-0.07 (n=16), respectively. The resolved R- and S-isomers of GR38032F were approximately equipotent as 5-HT antagonists on the rat vagus nerve: the pKB values were 8.95+/-0.05 (n=16) and 8.63+/-0.08 (n=17), respectively. R,S-GR38032F was also an effective antagonist of 5-HT on the rabbit isolated vagus nerve: in this case the pKB value was 9.40+/-0.14 (n=4).
Substance Class Chemical
Created
by admin
on Fri Dec 15 18:44:43 UTC 2023
Edited
by admin
on Fri Dec 15 18:44:43 UTC 2023
Record UNII
NMH84OZK2B
Record Status Validated (UNII)
Record Version
  • Download
Name Type Language
ONDANSETRON HYDROCHLORIDE
MART.   ORANGE BOOK   USAN   USP   USP-RS   VANDF  
USAN  
Official Name English
ONDANSETRON HYDROCHLORIDE DIHYDRATE [MI]
Common Name English
ONDANSETRON HCL
Common Name English
GR 38032F
Code English
ZOPHREN
Brand Name English
ONDANSETRON HYDROCHLORIDE [USP-RS]
Common Name English
4H-CARBAZOL-4-ONE, 1,2,3,9-TETRAHYDRO-9-METHYL-3-((2-METHYL-1H-IMIDAZOL-1-YL)METHYL)-, MONOHYDROCHLORIDE, (±)-, DIHYDRATE
Common Name English
ONDANSETRON HYDROCHLORIDE [USP MONOGRAPH]
Common Name English
ZOFRAN
Brand Name English
(±)-2,3-DIHYDRO-9-METHYL-3-((2-METHYLIMIDAZOL-1-YL)METHYL)CARBAZOL-4(1H)-ONE MONOHYDROCHLORIDE DIHYDRATE
Systematic Name English
SN-307
Code English
Ondansetron hydrochloride dihydrate [WHO-DD]
Common Name English
ONDANSETRON MONOHYDROCHLORIDE
Common Name English
GR-C507/75
Code English
GR-38032F
Code English
ONDANSETRON HYDROCHLORIDE HYDRATE
JAN  
Common Name English
ONDANSETRON HYDROCHLORIDE DIHYDRATE
MI   WHO-DD  
Common Name English
4H-CARBAZOL-4-ONE, 1,2,3,9-TETRAHYDRO-9-METHYL-3-((2-METHYL-1H-IMIDAZOL-1-YL)METHYL)-, HYDROCHLORIDE, HYDRATE (1:1:2)
Systematic Name English
ONDANSETRON HYDROCHLORIDE HYDRATE [JAN]
Common Name English
ONDANSETRON HYDROCHLORIDE [VANDF]
Common Name English
ONDANSETRON HYDROCHLORIDE DIHYDRATE [EP MONOGRAPH]
Common Name English
SN 307
Code English
ONDANSETRON HYDROCHLORIDE [USAN]
Common Name English
ONDANSETRON (AS HYDROCHLORIDE)
Common Name English
ONDANSETRON HYDROCHLORIDE [ORANGE BOOK]
Common Name English
ONDANSETRON HYDROCHLORIDE [MART.]
Common Name English
ODANSETRON HYDROCHLORIDE
Common Name English
Classification Tree Code System Code
NCI_THESAURUS C267
Created by admin on Fri Dec 15 18:44:43 UTC 2023 , Edited by admin on Fri Dec 15 18:44:43 UTC 2023
NCI_THESAURUS C94726
Created by admin on Fri Dec 15 18:44:43 UTC 2023 , Edited by admin on Fri Dec 15 18:44:43 UTC 2023
Code System Code Type Description
RXCUI
203148
Created by admin on Fri Dec 15 18:44:43 UTC 2023 , Edited by admin on Fri Dec 15 18:44:43 UTC 2023
PRIMARY RxNorm
EVMPD
SUB46120
Created by admin on Fri Dec 15 18:44:43 UTC 2023 , Edited by admin on Fri Dec 15 18:44:43 UTC 2023
PRIMARY
SMS_ID
100000131708
Created by admin on Fri Dec 15 18:44:43 UTC 2023 , Edited by admin on Fri Dec 15 18:44:43 UTC 2023
PRIMARY
USAN
Y-91
Created by admin on Fri Dec 15 18:44:43 UTC 2023 , Edited by admin on Fri Dec 15 18:44:43 UTC 2023
PRIMARY
FDA UNII
NMH84OZK2B
Created by admin on Fri Dec 15 18:44:43 UTC 2023 , Edited by admin on Fri Dec 15 18:44:43 UTC 2023
PRIMARY
ChEMBL
CHEMBL46
Created by admin on Fri Dec 15 18:44:43 UTC 2023 , Edited by admin on Fri Dec 15 18:44:43 UTC 2023
PRIMARY
NCI_THESAURUS
C48007
Created by admin on Fri Dec 15 18:44:43 UTC 2023 , Edited by admin on Fri Dec 15 18:44:43 UTC 2023
PRIMARY
MERCK INDEX
m8213
Created by admin on Fri Dec 15 18:44:43 UTC 2023 , Edited by admin on Fri Dec 15 18:44:43 UTC 2023
PRIMARY Merck Index
RS_ITEM_NUM
1478582
Created by admin on Fri Dec 15 18:44:43 UTC 2023 , Edited by admin on Fri Dec 15 18:44:43 UTC 2023
PRIMARY
PUBCHEM
59774
Created by admin on Fri Dec 15 18:44:43 UTC 2023 , Edited by admin on Fri Dec 15 18:44:43 UTC 2023
PRIMARY
DRUG BANK
DBSALT000921
Created by admin on Fri Dec 15 18:44:43 UTC 2023 , Edited by admin on Fri Dec 15 18:44:43 UTC 2023
PRIMARY
DAILYMED
NMH84OZK2B
Created by admin on Fri Dec 15 18:44:43 UTC 2023 , Edited by admin on Fri Dec 15 18:44:43 UTC 2023
PRIMARY
EVMPD
SUB03517MIG
Created by admin on Fri Dec 15 18:44:43 UTC 2023 , Edited by admin on Fri Dec 15 18:44:43 UTC 2023
PRIMARY
CAS
103639-04-9
Created by admin on Fri Dec 15 18:44:43 UTC 2023 , Edited by admin on Fri Dec 15 18:44:43 UTC 2023
PRIMARY
EPA CompTox
DTXSID9048857
Created by admin on Fri Dec 15 18:44:43 UTC 2023 , Edited by admin on Fri Dec 15 18:44:43 UTC 2023
PRIMARY
Related Record Type Details
BASIS OF STRENGTH->SUBSTANCE
ASSAY (HPLC)
USP
BASIS OF STRENGTH->SUBSTANCE
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
ANHYDROUS->SOLVATE
PARENT -> SALT/SOLVATE
Related Record Type Details
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
IMPURITY -> PARENT
sum of impurities A and G: not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (0.2 per cent)
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
sum of impurities A and G: not more than the area of the principal peak in the chromatogram obtained with reference solution (a) (0.2 per cent)
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
sum of impurities E and F: not more than the sum of the areas of the corresponding peaks in the chromatogram obtained with reference solution (g) (0.2 per cent)
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
IMPURITY -> PARENT
UNSPECIFIED
EP
IMPURITY -> PARENT
sum of impurities E and F: not more than the sum of the areas of the corresponding peaks in the chromatogram obtained with reference solution (g) (0.2 per cent)
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
For the calculation of contents, multiply the peak areas by 0.6
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (TLC)
EP
Related Record Type Details
ACTIVE MOIETY