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PHR1484

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Glyceryl Monooleate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

Glycerol mono-oleate

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About This Item

Empirical Formula (Hill Notation):
C21H40O4
CAS Number:
25496-72-4
Molecular Weight:
356.54
UNSPSC Code:
41116107
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

traceable to USP 1295753

API family

glyceryl monooleate

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

-10 to -25°C

InChI

1S/C21H40O4/c1-2-3-4-5-6-7-8-9-10-11-12-13-14-15-16-17-21(24)25-19-20(23)18-22/h9-10,20,22-23H,2-8,11-19H2,1H3/b10-9-

InChI key

RZRNAYUHWVFMIP-KTKRTIGZSA-N

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General description

Glyceryl Monooleate, commonly known as monoolein, is a glycerol monoester of oleic acid. Pharmaceutically, it is used as an emulsifier and permeation enhancer.
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

Glyceryl Monooleate may be used as a pharmaceutical reference standard for the determination of the analyte in bulk drug and pharmaceutical formulations by high performance liquid chromatography.
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 and BP 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.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAA3032 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

WGK

WGK 1

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Choose from one of the most recent versions:

Certificates of Analysis (COA)

Lot/Batch Number
LRAD5793
LRAD3413
LRAC9789
LRAC3245
LRAA3032

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Glyceryl Monooleate
USP43/NF38: United States Pharmacopeia and National Formulary
United States Pharmacopeia/National Formulary, 33(6), 5805-5805 (2013)
Monoolein: a review of the pharmaceutical applications
Ganem-Quintanar A, et al.
Drug Development and Industrial Pharmacy, 26(8), 809- 820 (2000)

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