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Carfilzomib Impurity 21
Rucaparib Impurity 6
Apremilast Impurity 35
Cyclophosphamide Impurity 11
Chlorambucil Monohydrate
Naloxone EP Impurity C
Open Ring Idelalisib
Brivaracetam Impurity 23
N-Acetyl L-Thyroxine Ethyl Ester
Cefixime Impurity 2
3-Hydroxycyclohexan-1-one
Cyclobenzaprine Dibenzosuberenone Impurity
Axitinib-d3
Ramelteon D5
Propylene Glycol
Lanreotide Impurity 3
Parecoxib Impurity 18
Abemaciclib N-Oxide Impurity 2
Siponimod Impurity 11
Gentamicin Impurity 9
Vortioxetine Glucose Adduct
Polyoxyethylene Lauryl Ether
Allochenodeoxycholic Acid
Budesonide 17-Carboxylic Acid Impurity
Pinaverium Impurity 12
Simvastatin Hydroxy Acid D6 (Sodium salt)
Delafloxacin Impurity 6
Cis-Ormeloxifene Hydrochloride
Baloxavir
Title Carfilzomib Impurity 21 Rucaparib Impurity 6 Apremilast Impurity 35 Cyclophosphamide Impurity 11 Chlorambucil Monohydrate Naloxone EP Impurity C Open Ring Idelalisib Brivaracetam Impurity 23 N-Acetyl L-Thyroxine Ethyl Ester Cefixime Impurity 2 3-Hydroxycyclohexan-1-one Cyclobenzaprine Dibenzosuberenone Impurity Axitinib-d3 Ramelteon D5 Propylene Glycol Lanreotide Impurity 3 Parecoxib Impurity 18 Abemaciclib N-Oxide Impurity 2 Siponimod Impurity 11 Gentamicin Impurity 9 Vortioxetine Glucose Adduct Polyoxyethylene Lauryl Ether Allochenodeoxycholic Acid Budesonide 17-Carboxylic Acid Impurity Pinaverium Impurity 12 Simvastatin Hydroxy Acid D6 (Sodium salt) Delafloxacin Impurity 6 Cis-Ormeloxifene Hydrochloride Baloxavir
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Description

Carfilzomib Impurity 21 is chemically (S)-4-Methyl-N-((S)-1-(((2S,3S)-3-methyl-1-((S)-2-methyloxiran-2-yl)-1-oxopentan-2-yl)amino)-1-oxo-3-phenylpropan-2-yl)-2-((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)pentanamide.
Carfilzomib Impurity 21 is supplied with detailed characterization data compliant with regulatory guideline. Carfilzomib Impurity 21 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Carfilzomib.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Rucaparib Impurity 6 is chemically 5-(4-(Aminomethyl)phenyl)-8-fluoro-2,3,4,6,8,9-hexahydro-1H-azepino[5,4,3-cd]indol-1-one.
Rucaparib Impurity 6 is supplied with detailed characterization data compliant with regulatory guideline. Rucaparib Impurity 6 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Rucaparib.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Apremilast Impurity 35 is chemically 1-(3-Ethoxy-4-methoxyphenyl)-2-((2-hydroxyethyl)sulfonyl)ethan-1-one.
Apremilast Impurity 35 is supplied with detailed characterization data compliant with regulatory guideline. Apremilast Impurity 35 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Apremilast.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Cyclophosphamide Impurity 11 is chemically N,N-Bis (2-chloroethyl)-N,N-bis(3-hydroxypropyl) phosphoric triamide.
Cyclophosphamide Impurity 11 is supplied with detailed characterization data compliant with regulatory guideline. Cyclophosphamide Impurity 11 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Cyclophosphamide.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Chlorambucil Monohydrate is chemically 4-(4-(Bis(2-chloroethyl)amino)phenyl)butanoic acid hydrate.
Chlorambucil Monohydrate is supplied with detailed characterization data compliant with regulatory guideline. Chlorambucil Monohydrate can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Chlorambucil.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Naloxone EP Impurity C is chemically 4,5α-Epoxy-3,10α,14-trihydroxy-17-(prop-2-enyl)morphinan-6-one (as per EP). It is also known as 10α-Hydroxynaloxone. Naloxone EP Impurity C is supplied with detailed characterization data compliant with regulatory guideline. Naloxone EP Impurity C can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Naloxon.The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Open Ring Idelalisibis chemically (S)-2-(2-((7H-Purin-6-yl)amino)butanamido)-6-fluoro-N-phenylbenzamide. Open Ring Idelalisib is supplied with detailed characterization data compliant with regulatory guideline. Open Ring Idelalisib can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Idelalisib .The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Brivaracetam Impurity 23 is chemically (4R)-2-Oxo-4-propyltetrahydrofuran-3-carboxylic acid.
Brivaracetam Impurity 23 is supplied with detailed characterization data compliant with regulatory guideline. Brivaracetam Impurity 23 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Brivaracetam.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

N-Acetyl L-Thyroxine Ethyl Ester is chemically Ethyl (S)-2-acetamido-3-(4-(4-hydroxy-3,5-diiodophenoxy)-3,5-diiodophenyl)propanoate.
N-Acetyl L-Thyroxine Ethyl Ester is supplied with detailed characterization data compliant with regulatory guideline. N-Acetyl L-Thyroxine Ethyl Ester can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Levothyroxine.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Cefixime Impurity 2 is chemically (E)-2-(((1-(2-Aminothiazol-4-yl)-2-((3-methyl-1,7-dioxo-1,4,5a,6-tetrahydro-3H,7H-azeto[2,1-b]furo[3,4-d][1,3]thiazin-6-yl)amino)-2-oxoethylidene)amino)oxy)acetic acid.
Cefixime Impurity 2 is supplied with detailed characterization data compliant with regulatory guideline. Cefixime Impurity 2 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Cefixime.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

3-Hydroxycyclohexan-1-one is chemically 3-hydroxycyclohexan-1-one.
3-Hydroxycyclohexan-1-one is supplied with detailed characterization data compliant with regulatory guideline. 3-Hydroxycyclohexan-1-one can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Miscellaneous.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Cyclobenzaprine Dibenzosuberenone Impurity is chemically Dibenzosuberenone ; Dibenzo[a,d]cyclohepten-5-one ;.
It is also known as Cyclobenzaprine Dibenzosuberenone Impurity .
Cyclobenzaprine Dibenzosuberenone Impurity is supplied with detailed characterization data compliant with regulatory guideline. Cyclobenzaprine Dibenzosuberenone Impurity can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Cyclobenzaprine.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Axitinib-d3 is chemically (E)-N-(Methyl-d3)-2-((3-(2-(pyridin-2-yl)vinyl)-1H-indazol-6-yl)thio)benzamide.
Axitinib-d3 is supplied with detailed characterization data compliant with regulatory guideline. Axitinib-d3 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Axitinib .

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Ramelteon D5 is chemically N-[2-[(8S)-1,6,7,8-Tetrahydro-2H-indeno[5,4-b]furan-8-yl]ethyl]propanamide-2,2,3,3,3-d5.
Ramelteon D5 is supplied with detailed characterization data compliant with regulatory guideline. Ramelteon D5 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Ramelteon.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Propylene Glycol is chemically 1,2-Propanediol.
Propylene Glycol is supplied with detailed characterization data compliant with regulatory guideline. Propylene Glycol can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Miscellaneous.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Lanreotide Impurity 3 is chemically (4R,7S,10S,13R,16S,19R)-13-((1H-Indol-3-yl)methyl)-19-((R)-2-amino-3-(naphthalen-2-yl)propanamido)-10-(4-aminobutyl)-16-(4-hydroxybenzyl)-7-isopropyl-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentaazacycloicosane-4-carboxamide.
Lanreotide Impurity 3 is supplied with detailed characterization data compliant with regulatory guideline. Lanreotide Impurity 3 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Lanreotide.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Parecoxib Impurity 18 is chemically 4,4′-(sulfonylbis(4,1-phenylene))bis(5-methyl-3-phenylisoxazole).
Parecoxib Impurity 18 is supplied with detailed characterization data compliant with regulatory guideline. Parecoxib Impurity 18 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Parecoxib.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Abemaciclib N-Oxide Impurity 2 is chemically 1-Ethyl-4-((6-((5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-yl)amino)pyridin-3-yl)methyl)piperazine 1-oxide.
Abemaciclib N-Oxide Impurity 2 is supplied with detailed characterization data compliant with regulatory guideline. Abemaciclib N-Oxide Impurity 2 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Abemaciclib.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Siponimod Impurity 11 is chemically (Z)-1-(4-(1-(((4-Cyclohexyl-2-(trifluoromethyl)phenyl)(hydroxy)methoxy)imino)ethyl)-2-ethylbenzyl)azetidine-3-carboxylic acid.
Siponimod Impurity 11 is supplied with detailed characterization data compliant with regulatory guideline. Siponimod Impurity 11 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Siponimod.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Gentamicin Impurity 9 is chemically 1-((2S,5S,6S)-5-amino-6-(((1S,2R,3S,4S,6S)-4,6-diamino-3-(((2R,3R,4S,5R)-3,5-dihydroxy-5-methyl-4-(methylamino)tetrahydro-2H-pyran-2-yl)oxy)-2-hydroxycyclohexyl)oxy)tetrahydro-2H-pyran-2-yl)-N-methylethan-1-imine oxide.
Gentamicin Impurity 9 is supplied with detailed characterization data compliant with regulatory guideline. Gentamicin Impurity 9 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Gentamicin.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Vortioxetine Glucose Adduct is chemically (2S,3R,4S,5S,6R)-2-(4-(2-((2,4-dimethylphenyl)thio)phenyl)piperazin-1-yl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol.
Vortioxetine Glucose Adduct is supplied with detailed characterization data compliant with regulatory guideline. Vortioxetine Glucose Adduct can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Vortioxetine.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Polyoxyethylene Lauryl Ether is chemically 3,6,9,12,15,18,21,24,27,30-Decaoxadotetracontan-1-ol.
Polyoxyethylene Lauryl Ether is supplied with detailed characterization data compliant with regulatory guideline. Polyoxyethylene Lauryl Ether can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Daptomycin.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Allochenodeoxycholic Acid is chemically (R)-4-((3R,5R,7R,8R,9S,10S,13R,14S,17R)-3,7-dihydroxy-10,13-dimethylhexadecahydro-1H-cyclopenta[a]phenanthren-17-yl)pentanoic acid.
Allochenodeoxycholic Acid is supplied with detailed characterization data compliant with regulatory guideline. Allochenodeoxycholic Acid can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Chenodeoxycholic acid.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Budesonide 17-Carboxylic Acid Impurity is chemically (6aR,6bS,7S,8aS,8bS,11aR,12aS,12bS)-7-Hydroxy-6a,8a-dimethyl-4-oxo-10-propyl-1,2,4,6a,6b,7,8,8a,11a,12,12a,12b-dodecahydro-8bH-naphtho[2′,1′:4,5]indeno[1,2-d][1,3]dioxole-8b-carboxylic acid.
Budesonide 17-Carboxylic Acid Impurity is supplied with detailed characterization data compliant with regulatory guideline. Budesonide 17-Carboxylic Acid Impurity can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Budesonide.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Pinaverium Impurity 12 is chemically 4-(2-(2-(6,6-Dimethylbicyclo[3.1.1]heptan-2-yl)ethoxy)ethyl)morpholine.
Pinaverium Impurity 12 is supplied with detailed characterization data compliant with regulatory guideline. Pinaverium Impurity 12 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Pinaverium.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Simvastatin Hydroxy Acid D6 (Sodium salt) is chemically (3R,5R)-7-((1S,2S,6R,8S,8aR)-8-((2,2-Bis(methyl-d3)butanoyl)oxy)-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)-3,5-dihydroxyheptanoic acid sodium salt.
Simvastatin Hydroxy Acid D6 (Sodium salt) is supplied with detailed characterization data compliant with regulatory guideline. Simvastatin Hydroxy Acid D6 (Sodium salt) can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Simvastatin.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Delafloxacin Impurity 6 is chemically 1-(6-Amino-3,5-difluoropyridin-2-yl)-8-chloro-6-fluoro-7-((oxiran-2-ylmethyl)amino)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid.
Delafloxacin Impurity 6 is supplied with detailed characterization data compliant with regulatory guideline. Delafloxacin Impurity 6 can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Delafloxacin.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Cis-Ormeloxifene Hydrochloride is chemically 1-(2-(4-((3R,4S)-7-Methoxy-2,2-dimethyl-3-phenylchroman-4-yl)phenoxy)ethyl)pyrrolidine hydrochloride.
Cis-Ormeloxifene Hydrochloride is supplied with detailed characterization data compliant with regulatory guideline. Cis-Ormeloxifene Hydrochloride can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Ormeloxifene.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Baloxavir is chemically (R)-12-((S)-7,8-difluoro-6,11-dihydrodibenzo[b,e]thiepin-11-yl)-7-hydroxy-3,4,12,12a-tetrahydro-1H-[1,4]oxazino[3,4-c]pyrido[2,1-f][1,2,4]triazine-6,8-dione.
Baloxavir is supplied with detailed characterization data compliant with regulatory guideline. Baloxavir can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Baloxavir marboxil.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. ISP Standards products are for analytical purpose only and not for human use.

Availability In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock In stock
CAS No           2139253-68-0 2118246-55-0 2052297-76-2 30804-52-5 108636-27-7 823-19-8 2222-33-5 1126623-89-9 1134159-63-9 57-55-6   2338845-31-9       2135577-60-3 9002-92-0 15357-34-3 192057-49-1 38284-47-8 2747915-76-8 2097714-11-7 51423-19-9 1985605-59-1
Inv. Status Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis In Stock Custom Synthesis Custom Synthesis In Stock Custom Synthesis Custom Synthesis In Stock Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis In Stock Custom Synthesis Custom Synthesis In Stock In Stock Custom Synthesis Custom Synthesis Custom Synthesis Custom Synthesis
Mol.F. C40H57N5O7 C18H18FN3O C13H18O6S C10H24Cl2N3O3P C14H19Cl2NO2 : H2O C19H21NO5 C22H20FN7O2 C8H12O4 C19H17I4NO5 C16H15N5O7S2 C6H10O2 C15H10O C22H15D3N4OS C16H16D5NO2 C3H8O2 C50H62N10O8S2 C32H24N2O4S C27H32F2N8O C29H35F3N2O4 C21H41N5O8 C24H32N2O5S C32H66O11 C24H40O4 C24H32O6 C17H31NO2 C25H34D6O6 : Na C18H12ClF3N4O4 C30H35NO3 : HCl C24H19F2N3O4S
ISP CAT No   ISP-R055010 ISP-A051059     ISP-N064004 ISP-I034004 ISP-B039034 ISP-L022037   ISP-M039184   ISP-A073D02 ISP-R008D01 ISP-M039314 ISP-L087004 ISP-P047021 ISP-A077031 ISP-S036015 ISP-G011028 ISP-V018004     ISP-B022019 ISP-P082015 ISP-S008D04   ISP-O027006 ISP-B052002
Mol.Wt. 719.9 311.4 302.3 336.2 304.2 : 18.0 343.4 433.4 172.2 847.0 453.4 114.1 206.2 389.5 264.4 76.1 995.2 532.6 522.6 532.6 491.6 460.6 626.9 392.6 416.5 281.4 442.6 : 23.0 440.8 457.6 : 36.5 483.5