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PHR1078

Supelco

Phytonadione

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):
2-Methyl-3-phytyl-1,4-naphthoquinone, 3-Phytylmenadione, Vitamin K1(20), Vitamin K1, Phytomenadione, Phylloquinone
Empirical Formula (Hill Notation):
C31H46O2
CAS Number:
Molecular Weight:
450.70
Beilstein:
2568816
EC Number:
MDL number:
PubChem Substance ID:
NACRES:
NA.24

Quality Level

grade

certified reference material
pharmaceutical secondary standard

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

pharmacopeia traceability

traceable to BP 423
traceable to PhEur P1609000
traceable to USP 1538006

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

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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, EP (PhEur) and BP primary standards, where they are available.

Other Notes

Values of analytes vary lot to lot.
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.

Footnote

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.

Storage Class Code

12 - Non Combustible Liquids

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Certificate of Analysis

Certificate of Origin

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)
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)
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)
Treatment of excessive anticoagulation with phytonadione (vitamin K): a meta-analysis
DeZee KJ, et al.
Archives of Internal Medicine, 166(4), 391-397 (2006)
Ellen C M Cranenburg et al.
Kidney international, 82(5), 605-610 (2012-06-01)
Vitamin K is essential for the activity of γ-carboxyglutamate (Gla)-proteins including matrix Gla28 protein and osteocalcin; an inhibitor of vascular calcification and a bone matrix protein, respectively. Insufficient vitamin K intake leads to the production of non-carboxylated, inactive proteins and

Protocols

HPLC Analysis of Fat-Soluble Vitamins on Ascentis® Express C18, Methanol Mobile Phase

Separation of Retinyl acetate, analytical standard; δ-Tocopherol, analytical standard; Ergocalciferol (D2), analytical standard; Cholecalciferol (D3), analytical standard; (±)-α-Tocopherol, analytical standard; Vitamin E acetate, analytical standard; Phylloquinone (K1), analytical standard; Retinol palmitate, analytical standard.

HPLC Analysis of Fat Soluble Vitamins on Ascentis® Express RP-Amide, Acetonitrile Mobile Phase

Separation of Retinyl acetate, analytical standard; Vitamin E acetate, analytical standard; Phylloquinone (K1), analytical standard; Ergocalciferol (D2), analytical standard; Cholecalciferol (D3), analytical standard; (±)-α-Tocopherol, analytical standard; δ-Tocopherol, analytical standard; Retinol palmitate, analytical standard

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