U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Details

Stereochemistry ACHIRAL
Molecular Formula C15H11N2O2.Na
Molecular Weight 274.2504
Optical Activity NONE
Defined Stereocenters 0 / 0
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of PHENYTOIN SODIUM

SMILES

c1ccc(cc1)C2(c3ccccc3)C(=NC(=N2)O)[O-].[Na+]

InChI

InChIKey=FJPYVLNWWICYDW-UHFFFAOYSA-M
InChI=1S/C15H12N2O2.Na/c18-13-15(17-14(19)16-13,11-7-3-1-4-8-11)12-9-5-2-6-10-12;/h1-10H,(H2,16,17,18,19);/q;+1/p-1

HIDE SMILES / InChI

Molecular Formula Na
Molecular Weight 22.9898
Charge 1
Count
Stereochemistry ACHIRAL
Additional Stereochemistry No
Defined Stereocenters 0 / 0
E/Z Centers 0
Optical Activity NONE

Molecular Formula C15H12N2O2
Molecular Weight 252.2685
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 http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020450s020lbl.pdf

Phenytoin is an anti-epileptic drug. Phenytoin has been used with much clinical success against all types of epileptiform seizures, except petit mal epilepsy. Phenytoin is a available for oral administration (tablets, capsules, suspension). CEREBYX® (fosphenytoin sodium injection) is a prodrug intended for parenteral administration; its active metabolite is phenytoin. CEREBYX should be used only when oral phenytoin administration is not possible. Although several potential targets for phenytoin action have been identified within the CNS (Na-K-ATPase, the GABAA receptor complex, ionotropic glutamate receptors, calcium channels and sigma binding sites) to date, though, the best evidence hinges on the inhibition of voltage-sensitive Na+ channels in the plasma membrane of neurons undergoing seizure activity.

Approval Year

TargetsConditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
DILANTIN-125

Approved Use

Dilantin (phenytoin) is indicated for the control of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures

Launch Date

-5.36025596E11
Primary
CEREBYX

Approved Use

CEREBYX is indicated for the control of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. CEREBYX can also be substituted, short-term, for oral phenytoin. CEREBYX should be used only when oral phenytoin administration is not possible. CEREBYX must not be given orally.

Launch Date

8.3911678E11
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
1.176 μg/mL
100 mg single, oral
dose: 100 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PHENYTOIN plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
32.172 μg × h/mL
100 mg single, oral
dose: 100 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PHENYTOIN plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
15.49 h
100 mg single, oral
dose: 100 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
PHENYTOIN plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: MALE
food status: FASTED
Doses

Doses

DosePopulationAdverse events​
600 mg single, oral
Highest studied dose
unhealthy, 31 years
n = 15
Health Status: unhealthy
Condition: epilepsy
Age Group: 31 years
Sex: M+F
Population Size: 15
Sources:
20 g single, oral
Overdose
Dose: 20 g
Route: oral
Route: single
Dose: 20 g
Co-administed with::
glibenclamide(500 mg)
Sources:
unhealthy, 41 years
n = 1
Health Status: unhealthy
Age Group: 41 years
Sex: F
Population Size: 1
Sources:
Other AEs: Sinus bradycardia, Hypotension...
Other AEs:
Sinus bradycardia (1 patient)
Hypotension (severe, 1 patient)
Sources:
5 g single, oral
Overdose
Dose: 5 g
Route: oral
Route: single
Dose: 5 g
Sources:
unhealthy, 49 years
n = 1
Health Status: unhealthy
Age Group: 49 years
Sex: M
Population Size: 1
Sources:
Other AEs: Acute respiratory failure...
Other AEs:
Acute respiratory failure (1 patient)
Sources:
60 mg/kg multiple, intravenous (total)
Overdose
Dose: 60 mg/kg
Route: intravenous
Route: multiple
Dose: 60 mg/kg
Sources:
unhealthy, 7 years
n = 1
Health Status: unhealthy
Age Group: 7 years
Sex: M
Population Size: 1
Sources:
Other AEs: Encephalopathy...
Other AEs:
Encephalopathy (1 patient)
Sources:
2 g single, oral
Overdose
Dose: 2 g
Route: oral
Route: single
Dose: 2 g
Sources:
unhealthy, adult
Other AEs: Nystagmus, Ataxia...
Other AEs:
Nystagmus (grade 5)
Ataxia (grade 5)
Dysarthria (grade 5)
Tremor (grade 5)
Hyperreflexia (grade 5)
Lethargy (grade 5)
Slurred speech (grade 5)
Blurred vision (grade 5)
Nausea (grade 5)
Vomiting (grade 5)
Sources:
10 mg/kg single, intramuscular (starting)
Dose: 10 mg/kg
Route: intramuscular
Route: single
Dose: 10 mg/kg
Sources:
unhealthy, adult
Other AEs: Hypotension, Cardiac arrhythmias...
Other AEs:
Hypotension (severe)
Cardiac arrhythmias
Sources:
10 mg/kg single, intravenous (starting)
Dose: 10 mg/kg
Route: intravenous
Route: single
Dose: 10 mg/kg
Sources:
unhealthy, adult
Other AEs: Hypotension, Cardiac arrhythmias...
Other AEs:
Hypotension (severe)
Cardiac arrhythmias
Sources:
AEs

AEs

AESignificanceDosePopulation
Sinus bradycardia 1 patient
20 g single, oral
Overdose
Dose: 20 g
Route: oral
Route: single
Dose: 20 g
Co-administed with::
glibenclamide(500 mg)
Sources:
unhealthy, 41 years
n = 1
Health Status: unhealthy
Age Group: 41 years
Sex: F
Population Size: 1
Sources:
Hypotension severe, 1 patient
20 g single, oral
Overdose
Dose: 20 g
Route: oral
Route: single
Dose: 20 g
Co-administed with::
glibenclamide(500 mg)
Sources:
unhealthy, 41 years
n = 1
Health Status: unhealthy
Age Group: 41 years
Sex: F
Population Size: 1
Sources:
Acute respiratory failure 1 patient
5 g single, oral
Overdose
Dose: 5 g
Route: oral
Route: single
Dose: 5 g
Sources:
unhealthy, 49 years
n = 1
Health Status: unhealthy
Age Group: 49 years
Sex: M
Population Size: 1
Sources:
Encephalopathy 1 patient
60 mg/kg multiple, intravenous (total)
Overdose
Dose: 60 mg/kg
Route: intravenous
Route: multiple
Dose: 60 mg/kg
Sources:
unhealthy, 7 years
n = 1
Health Status: unhealthy
Age Group: 7 years
Sex: M
Population Size: 1
Sources:
Ataxia grade 5
2 g single, oral
Overdose
Dose: 2 g
Route: oral
Route: single
Dose: 2 g
Sources:
unhealthy, adult
Blurred vision grade 5
2 g single, oral
Overdose
Dose: 2 g
Route: oral
Route: single
Dose: 2 g
Sources:
unhealthy, adult
Dysarthria grade 5
2 g single, oral
Overdose
Dose: 2 g
Route: oral
Route: single
Dose: 2 g
Sources:
unhealthy, adult
Hyperreflexia grade 5
2 g single, oral
Overdose
Dose: 2 g
Route: oral
Route: single
Dose: 2 g
Sources:
unhealthy, adult
Lethargy grade 5
2 g single, oral
Overdose
Dose: 2 g
Route: oral
Route: single
Dose: 2 g
Sources:
unhealthy, adult
Nausea grade 5
2 g single, oral
Overdose
Dose: 2 g
Route: oral
Route: single
Dose: 2 g
Sources:
unhealthy, adult
Nystagmus grade 5
2 g single, oral
Overdose
Dose: 2 g
Route: oral
Route: single
Dose: 2 g
Sources:
unhealthy, adult
Slurred speech grade 5
2 g single, oral
Overdose
Dose: 2 g
Route: oral
Route: single
Dose: 2 g
Sources:
unhealthy, adult
Tremor grade 5
2 g single, oral
Overdose
Dose: 2 g
Route: oral
Route: single
Dose: 2 g
Sources:
unhealthy, adult
Vomiting grade 5
2 g single, oral
Overdose
Dose: 2 g
Route: oral
Route: single
Dose: 2 g
Sources:
unhealthy, adult
Cardiac arrhythmias
10 mg/kg single, intramuscular (starting)
Dose: 10 mg/kg
Route: intramuscular
Route: single
Dose: 10 mg/kg
Sources:
unhealthy, adult
Hypotension severe
10 mg/kg single, intramuscular (starting)
Dose: 10 mg/kg
Route: intramuscular
Route: single
Dose: 10 mg/kg
Sources:
unhealthy, adult
Cardiac arrhythmias
10 mg/kg single, intravenous (starting)
Dose: 10 mg/kg
Route: intravenous
Route: single
Dose: 10 mg/kg
Sources:
unhealthy, adult
Hypotension severe
10 mg/kg single, intravenous (starting)
Dose: 10 mg/kg
Route: intravenous
Route: single
Dose: 10 mg/kg
Sources:
unhealthy, adult
OverviewDrug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
no
no
weak
yes [IC50 145 uM]
yes [IC50 280 uM]
yes [IC50 607 uM]
yes
yes
likely (co-administration study)
Comment: See https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/084427s042lbl.pdf#page=10
yes
likely (co-administration study)
Comment: See https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/084427s042lbl.pdf#page=10
yes
likely (co-administration study)
Comment: See https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/084427s042lbl.pdf#page=11
Page: 46.0
yes
likely (co-administration study)
Comment: See https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/084427s042lbl.pdf#page=9
yes
likely (co-administration study)
Comment: See https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/084427s042lbl.pdf#page=11
yes
yes (co-administration study)
Comment: mean AUC(0-24) of losartan was insignificantly increased by 17% when losartan was coadministered with phenytoin. See more on https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/084427s042lbl.pdf#page=9
Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
no
yes
yes
yes
likely (co-administration study)
Comment: See https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/084427s042lbl.pdf#page=9
yes
yes (co-administration study)
Comment: Coadministration of losartan had no effect on the pharmacokinetics of phenytoin. See more on https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/084427s042lbl.pdf#page8
Page: 8.0
Tox targets

Tox targets

TargetModalityActivityMetaboliteClinical evidence
PubMed

PubMed

TitleDatePubMed
Harmful effect of megadoses of vitamins: electroencephalogram abnormalities and seizures induced by intravenous folate in drug-treated epileptics.
1975 Jan
Anticonvulsant-induced dyskinesias: a comparison with dyskinesias induced by neuroleptics.
1976 Dec
Diphenylhydantoin teratogenicity: ocular manifestations and related deformities.
1978 May-Jun
Psychopharmacological studies on (--)-nuciferine and its Hofmann degradation product atherosperminine.
1978 Sep 15
Extremely acute phenytoin-induced peripheral neuropathy.
1999 Apr
Pharmacokinetics of chlorpheniramine, phenytoin, glipizide and nifedipine in an individual homozygous for the CYP2C9*3 allele.
1999 Feb
Interaction between phenytoin and ciprofloxacin.
1999 Feb
Cognitive dysfunction induced by phenytoin and valproate in rats: effect of nitric oxide.
1999 Jul
Dyskinesia induced by phenytoin.
1999 Jun
A reporter gene assay to assess the molecular mechanisms of xenobiotic-dependent induction of the human CYP3A4 gene in vitro.
1999 Mar
Systemic vasculitis associated with long-term phenytoin therapy.
1999 Mar 26
Developmental effects of phenytoin may differ depending on sex of offspring.
1999 Mar-Apr
Tuberous sclerosis associated with MDR1 gene expression and drug-resistant epilepsy.
1999 Oct
Side effects and mortality associated with use of phenytoin for early posttraumatic seizure prophylaxis.
1999 Oct
Incidence and clinical consequence of the purple glove syndrome in patients receiving intravenous phenytoin.
1999 Oct 22
Frequency of cytochrome P450 CYP2C9 variants in a Turkish population and functional relevance for phenytoin.
1999 Sep
[Acute liver failure by diphenylhydantoin].
2000
Anticonvulsant-induced suppression of IFN-gamma production by lymphocytes obtained from cervical lymph nodes in glioma-bearing mice.
2000 Apr
Protection from phenytoin-induced cognitive deficit by Bacopa monniera, a reputed Indian nootropic plant.
2000 Aug
Phenytoin, midazolam, and naloxone protect against fentanyl-induced brain damage in rats.
2000 Dec
Felbamate in experimental model of status epilepticus.
2000 Feb
Images in clinical medicine. Gingival hyperplasia induced by phenytoin.
2000 Feb 3
Immunolocalizaiton of c-Myc and bcl-2 proto-oncogene products in gingival hyperplasia induced by nifedipine and phenytoin.
2000 Jan
An embryoprotective role for glucose-6-phosphate dehydrogenase in developmental oxidative stress and chemical teratogenesis.
2000 Jan
Cerebral edema with herniation during acetaminophen-induced fulminant hepatic failure.
2000 Jul
Gabapentin prophylaxis of clozapine-induced seizures.
2000 Mar
Activation of cytochrome P450 gene expression in the rat brain by phenobarbital-like inducers.
2000 Sep
Evaluation of the neuroprotective effects of sodium channel blockers after spinal cord injury: improved behavioral and neuroanatomical recovery with riluzole.
2001 Apr
Decreases in phenytoin hydroxylation activities catalyzed by liver microsomal cytochrome P450 enzymes in phenytoin-treated rats.
2001 Apr
Cardiac arrest after fast intravenous infusion of phenytoin mistaken for fosphenytoin.
2001 Feb
Antiepileptic drug withdrawal in patients with temporal lobe epilepsy undergoing presurgical video-EEG monitoring.
2001 Feb
Fosphenytoin: pharmacokinetics and tolerance of intramuscular loading doses.
2001 Feb
Glutamate receptor antagonists differentially affect the protective activity of conventional antiepileptics against amygdala-kindled seizures in rats.
2001 Feb
Possible function of astrocyte cytochrome P450 in control of xenobiotic phenytoin in the brain: in vitro studies on murine astrocyte primary cultures.
2001 Feb
[Maintenance dose requirement for phenytoin is lowered in genetically impaired drug metabolism independent of concommitant use of other antiepileptics].
2001 Feb 17
Interferon-alpha2a and 13-cis-retinoic acid with radiation treatment for high-grade glioma.
2001 Jan
Inhibition of human cytochrome P450 isoforms by nonnucleoside reverse transcriptase inhibitors.
2001 Jan
Treatment of nonfebrile status epilepticus in Rochester, Minn, from 1965 through 1984.
2001 Jan
Effects of antiepileptic drugs on rat platelet aggregation: ex vivo and in vitro study.
2001 Jan
N6-cyclohexyladenosine and 3-(2-carboxypiperazine-4-yl)-1-propenyl-1-phosphonic acid enhance the effect of antiepileptic drugs against induced seizures in mice.
2001 Jan-Apr
Volume-selective proton MR spectroscopy for in-vitro quantification of anticonvulsants.
2001 Mar
Influence of retigabine on the anticonvulsant activity of some antiepileptic drugs against audiogenic seizures in DBA/2 mice.
2001 Mar
Efficacy of levetiracetam versus fosphenytoin for the recurrence of seizures after status epilepticus.
2017 Jun
Patents

Sample Use Guides

Dilantin-125® (Phenytoin Oral Suspension, USP), each 5 ml of suspension contains 125 mg of phenytoin: Patients who have received no previous treatment may be started on one teaspoonful (5 mL) of Dilantin-125 Suspension three times daily, and the dose is then adjusted to suit individual requirements. An increase to five teaspoonfuls daily may be made, if necessary. CEREBYX® (fosphenytoin sodium injection) is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium is equivalent to 1 mg phenytoin sodium, and is referred to as 1 mg phenytoin sodium equivalents (PE). CEREBYX should be used only when oral phenytoin administration is not possible. Dosage (Status Epilepticus): The loading dose of CEREBYX is 15 to 20 mg PE/kg administered at 100 to 150 mg PE/min.
Route of Administration: Other
Exposure of human adult keratinocytes (HaCaT cells) for 48 h to alkyd nanoemulsions producing phenytoin concentrations of 3.125-200 μg/mL resulted in relative cell viability readings using tetrazolium dye 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide of 100% confirming nontoxicity and suggesting cell proliferation activity.
Substance Class Chemical
Created
by admin
on Fri Jun 25 21:01:14 UTC 2021
Edited
by admin
on Fri Jun 25 21:01:14 UTC 2021
Record UNII
4182431BJH
Record Status Validated (UNII)
Record Version
  • Download
Related Record Type
Name Type Language
PHENYTOIN SODIUM
EP   GREEN BOOK   MART.   ORANGE BOOK   USP   USP-RS   VANDF   WHO-DD   WHO-IP  
Common Name English
PHENYTOIN SODIUM SALT [MI]
Common Name English
PHENYTOIN SODIUM [EP]
Common Name English
DIPHENYLHYDANTOIN SODIUM
GREEN BOOK  
Systematic Name English
PHENYTOIN SODIUM [WHO-DD]
Common Name English
PHENYTOIN SODIUM [ORANGE BOOK]
Common Name English
TACOSAL
Common Name English
HYDANTOINAL
Systematic Name English
5,5-DIPHENYLHYDANTOIN SODIUM SALT
Common Name English
PHENYTOIN SODIUM [MART.]
Common Name English
PHENYTOINUM NATRICUM [WHO-IP LATIN]
Common Name English
PHENYTOIN SODIUM [USP MONOGRAPH]
Common Name English
PHENYTOIN SODIUM SALT
MI  
Common Name English
PHENYTOIN SODIUM FOR INJECTION [JAN]
Common Name English
PHENYTOIN SODIUM [EP MONOGRAPH]
Common Name English
PHENYTEK
Brand Name English
2,4-IMIDAZOLIDINEDIONE, 5,5-DIPHENYL-, MONOSODIUM SALT
Common Name English
NSC-757274
Code English
PHENYTOIN SODIUM [VANDF]
Common Name English
ANTISACER
Common Name English
PHENYTOIN SODIUM [USP-RS]
Common Name English
PHENYTOIN SODIUM [WHO-IP]
Common Name English
DIPHENYLHYDANTOIN SODIUM [GREEN BOOK]
Common Name English
Classification Tree Code System Code
NCI_THESAURUS C264
Created by admin on Fri Jun 25 21:01:14 UTC 2021 , Edited by admin on Fri Jun 25 21:01:14 UTC 2021
NCI_THESAURUS C93038
Created by admin on Fri Jun 25 21:01:14 UTC 2021 , Edited by admin on Fri Jun 25 21:01:14 UTC 2021
CFR 21 CFR 522.900
Created by admin on Fri Jun 25 21:01:14 UTC 2021 , Edited by admin on Fri Jun 25 21:01:14 UTC 2021
Code System Code Type Description
PUBCHEM
657302
Created by admin on Fri Jun 25 21:01:14 UTC 2021 , Edited by admin on Fri Jun 25 21:01:14 UTC 2021
PRIMARY
RXCUI
71227
Created by admin on Fri Jun 25 21:01:14 UTC 2021 , Edited by admin on Fri Jun 25 21:01:14 UTC 2021
PRIMARY RxNorm
CAS
630-93-3
Created by admin on Fri Jun 25 21:01:14 UTC 2021 , Edited by admin on Fri Jun 25 21:01:14 UTC 2021
PRIMARY
FDA UNII
4182431BJH
Created by admin on Fri Jun 25 21:01:14 UTC 2021 , Edited by admin on Fri Jun 25 21:01:14 UTC 2021
PRIMARY
DRUG BANK
DBSALT000139
Created by admin on Fri Jun 25 21:01:14 UTC 2021 , Edited by admin on Fri Jun 25 21:01:14 UTC 2021
PRIMARY
USP_CATALOG
1535507
Created by admin on Fri Jun 25 21:01:14 UTC 2021 , Edited by admin on Fri Jun 25 21:01:14 UTC 2021
PRIMARY USP-RS
EVMPD
SUB03787MIG
Created by admin on Fri Jun 25 21:01:14 UTC 2021 , Edited by admin on Fri Jun 25 21:01:14 UTC 2021
PRIMARY
WHO INTERNATIONAL PHARMACOPEIA
PHENYTOIN SODIUM
Created by admin on Fri Jun 25 21:01:14 UTC 2021 , Edited by admin on Fri Jun 25 21:01:14 UTC 2021
PRIMARY Description: A white powder; odourless. Solubility: Soluble in water, giving a slightly turbid solution owing to partial hydrolysis; soluble in ethanol (~750 g/l) TS; practicallyinsoluble in ether R. Category: Anticonvulsant. Storage: Phenytoin sodium should be kept in a tightly closed container. Additional information: Phenytoin sodium is somewhat hygroscopic and on exposure to air gradually absorbs carbon dioxide. Definition: Phenytoin sodium contains not less than 98.5% and not more than 101.0% of C15H11N2NaO2, calculated withreference to the dried substance.
ECHA (EC/EINECS)
211-148-2
Created by admin on Fri Jun 25 21:01:14 UTC 2021 , Edited by admin on Fri Jun 25 21:01:14 UTC 2021
PRIMARY
ChEMBL
CHEMBL16
Created by admin on Fri Jun 25 21:01:14 UTC 2021 , Edited by admin on Fri Jun 25 21:01:14 UTC 2021
PRIMARY
NCI_THESAURUS
C48011
Created by admin on Fri Jun 25 21:01:14 UTC 2021 , Edited by admin on Fri Jun 25 21:01:14 UTC 2021
PRIMARY
MERCK INDEX
M8703
Created by admin on Fri Jun 25 21:01:14 UTC 2021 , Edited by admin on Fri Jun 25 21:01:14 UTC 2021
PRIMARY Merck Index
Related Record Type Details
BASIS OF STRENGTH->SUBSTANCE
ASSAY (TITRATION)
EP
SUB_CONCEPT->SUBSTANCE
LABELED -> NON-LABELED
BASIS OF STRENGTH->SUBSTANCE
ASSAY (HPLC)
USP
PARENT -> SALT/SOLVATE
SUB_CONCEPT->SUBSTANCE
Related Record Type Details
IMPURITY -> PARENT
EP
IMPURITY -> PARENT
CHROMATOGRAPHIC PURITY (HPLC/UV)
USP
IMPURITY -> PARENT
UNSPECIFIED
EP
IMPURITY -> PARENT
For the calculation of contents, multiply the peak areas by 1.7
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
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 1.4
CHROMATOGRAPHIC PURITY (HPLC/UV)
EP
IMPURITY -> PARENT
UNSPECIFIED
EP
Related Record Type Details
ACTIVE MOIETY