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PHR1078

Phytonadione

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Vitamin K1, Phytomenadione, 2-Methyl-3-phytyl-1,4-naphthoquinone, 3-Phytylmenadione, Phylloquinone, Vitamin K1(20)

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About This Item

Empirical Formula (Hill Notation):
C31H46O2
CAS Number:
84-80-0
Molecular Weight:
450.70
UNSPSC Code:
41116107
NACRES:
NA.24
PubChem Substance ID:
329823101
EC Number:
201-564-2
Beilstein/REAXYS Number:
2568816
MDL number:
MFCD00214063
eCl@ss:
34058015
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Quality Level

300

grade

certified reference material, pharmaceutical secondary standard

agency

USP 1538006, traceable to Ph. Eur. P1609000

API family

phytonadione

CofA

current certificate can be downloaded

storage condition

protect from light

technique(s)

HPLC: suitable, gas chromatography (GC): suitable

refractive index

n20/D 1.527 (lit.)

mp

−20 °C (lit.)

density

0.984 g/mL at 25 °C (lit.)

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

2-8°C

SMILES string

O=C(C1=CC=CC=C21)C(C)=C(C/C=C(CCC[C@@H](CCC[C@H](C)CCCC(C)C)C)\C)C2=O

InChI

1S/C31H46O2/c1-22(2)12-9-13-23(3)14-10-15-24(4)16-11-17-25(5)20-21-27-26(6)30(32)28-18-7-8-19-29(28)31(27)33/h7-8,18-20,22-24H,9-17,21H2,1-6H3/b25-20+/t23-,24-/m1/s1

InChI key

MBWXNTAXLNYFJB-NKFFZRIASA-N

General description

Phytonadione belongs to the category of oral anticonvulsant drugs. It protects a newborn from acquiring hemorrhagic diseases by maintaining a normal blood clotting mechanism.
Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.

Application

Phytonadione may be used as a pharmaceutical reference standard in the determination of the analyte in pharmaceutical formulations by chromatographic and spectrophotometric techniques.
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP and EP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.
To see an example of a Certificate of Analysis for this material enter LRAB3714 in the slot below. This is an example certificate only and may not be the lot that you receive.
Values of analytes vary lot to lot.

Storage Class

10 - Combustible liquids

wgk

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable

Regulatory Listings

Regulatory Listings are mainly provided for chemical products. Only limited information can be provided here for non-chemical products. No entry means none of the components are listed. It is the user’s obligation to ensure the safe and legal use of the product.

Group 4: Flammable liquids + Type 3 petroleums + Hazardous rank III + Water insoluble liquid

fsl

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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Comparison of oral vs intravenous phytonadione (vitamin K1) in patients with excessive anticoagulation: a prospective randomized controlled study
Lubetsky A, et al.
Archives of Internal Medicine, 163(20), 2469-2473 (2003)
Development and validation of spectrophotometric methods fordetermination of phytomenadione in injection
Patel SA and Parikh PK
Current Research in Pharmaceutical Sciences, 39(17-18), 26-30 (2012)
NP-HPLC method for determining phytonadione and its impurities
Xue M, et al.
Journal of Liquid Chromatography and Related Technologies, 39(17-18), 799-805 (2016)
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