Scribd
Upload
215 views2 pages

USP-NF Ethyl Vanillin

This document defines the monograph specifications for ethyl vanillin, including its chemical structure, identification tests, assay method, impurities limits, specific tests for melting range and loss on drying, packaging and storage requirements, and reference standard information. The assay method involves titrating a sample of ethyl vanillin dissolved in dimethylformamide with sodium methoxide solution and calculating the percentage of ethyl vanillin based on the titration results. Specifications include an assay range of 98.0-101.0% and limits for residue on ignition, melting range, and loss on drying.

Uploaded by

Mohamed Boumahraz
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
215 views2 pages

USP-NF Ethyl Vanillin

This document defines the monograph specifications for ethyl vanillin, including its chemical structure, identification tests, assay method, impurities limits, specific tests for melting range and loss on drying, packaging and storage requirements, and reference standard information. The assay method involves titrating a sample of ethyl vanillin dissolved in dimethylformamide with sodium methoxide solution and calculating the percentage of ethyl vanillin based on the titration results. Specifications include an assay range of 98.0-101.0% and limits for residue on ignition, melting range, and loss on drying.

Uploaded by

Mohamed Boumahraz
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

11/7/2020 USP-NF Ethyl Vanillin

Printed on: Sat Nov 07 2020, 11:01:36 am


Printed by: Shruti Kharidia
O cial Status: Currently O cial on 07-Nov-2020
O cial Date: O cial as of 1-May-2020
Document Type: NF
DocId: 1_GUID-AF67FBA6-1210-44EE-BC8F-D055654AEB9D_2_en-US
Printed from: https://online.uspnf.com/uspnf/document/1_GUID-AF67FBA6-1210-44EE-BC8F-D055654AEB9D_2_en-US
© 2020 USPC

Ethyl Vanillin

C9H10O3 166.17
Benzaldehyde, 3-ethoxy-4-hydroxy-;
3-Ethoxy-4-hydroxybenzaldehyde [121-32-4].

DEFINITION
Ethyl Vanillin, dried over phosphorus pentoxide for 4 h, contains NLT 98.0% and NMT 101.0% of C9H10O3.

IDENTIFICATION

Change to read:
• A. ▲SPECTROSCOPIC IDENTIFICATION TESTS 〈197〉, Infrared Spectroscopy: 197K▲ (CN 1-MAY-2020)

Change to read:
• B. ▲SPECTROSCOPIC IDENTIFICATION TESTS 〈197〉, Ultraviolet-Visible Spectroscopy: 197U▲ (CN 1-MAY-2020)
Sample solution: 8 µg/mL in methanol
Acceptance criteria: Meets the requirements L
IA
ASSAY
• PROCEDURE
Sample: 300 mg of Ethyl Vanillin (previously dried)
Titrimetric system
IC

(See Titrimetry 〈541〉.)


Mode: Direct titration
Titrant: 0.1 N sodium methoxide VS
Blank: 50 mL of dimethylformamide, accurately measured
Endpoint detection: Visual
FF

Analysis: Transfer the Sample solution to a 125-mL conical ask, and dissolve in 50 mL of dimethylformamide. Add thymol blue TS
and titrate, using a magnetic stirrer and taking precautions against the absorption of atmospheric carbon dioxide. Perform a blank
determination. Calculate the percentage of ethyl vanillin (C9H10O3) in the Sample taken:

Result = {[(VS − VB) × N × F]/W} × 100


O

VS = Titrant volume consumed by the Sample (mL)

VB = Titrant volume consumed by the Blank (mL)

N = actual normality of the Titrant (mEq/mL)

F = equivalency factor, 166.2 mg/mEq

W = Sample weight (mg)

Acceptance criteria: 98.0%–101.0% on the previously dried basis

IMPURITIES
• RESIDUE ON IGNITION 〈281〉: NMT 0.1%

SPECIFIC TESTS
• MELTING RANGE OR TEMPERATURE 〈741〉: 76°–78°
• LOSS ON DRYING 〈731〉: Dry a sample over phosphorus pentoxide for 4 h: it loses NMT 1.0% of its weight.

ADDITIONAL REQUIREMENTS

https://online.uspnf.com/uspnf/document/1_GUID-AF67FBA6-1210-44EE-BC8F-D055654AEB9D_2_en-US?source=TOC 1/2
11/7/2020 USP-NF Ethyl Vanillin

• PACKAGING AND STORAGE: Preserve in tight, light-resistant containers.


• USP REFERENCE STANDARDS 〈11〉
USP Ethyl Vanillin RS

Auxiliary Information- Please check for your question in the FAQs before contacting USP.

Topic/Question Contact Expert Committee

ETHYL VANILLIN Galina Holloway SE2020 Simple Excipients


Senior Scienti c Liaison

Chromatographic Database Information: Chromatographic Database

Page Information:

USP43-NF38 - 5763
USP42-NF37 - 5716
USP41-NF36 - 5340

Current DocID: GUID-AF67FBA6-1210-44EE-BC8F-D055654AEB9D_2_en-US

L
IA
IC
FF
O

https://online.uspnf.com/uspnf/document/1_GUID-AF67FBA6-1210-44EE-BC8F-D055654AEB9D_2_en-US?source=TOC 2/2

You might also like