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Acetylcholine Chloride

The document outlines the specifications and testing methods for Acetylcholine Chloride, including its chemical composition, identification tests, and acceptance criteria for purity and impurities. It specifies that Acetylcholine Chloride must contain between 98.0% and 102.0% of the compound on a dried basis, along with detailed procedures for assays and additional requirements for packaging and storage. The document is officially recognized as of May 1, 2020, and includes references to relevant USP standards.

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34 views1 page

Acetylcholine Chloride

The document outlines the specifications and testing methods for Acetylcholine Chloride, including its chemical composition, identification tests, and acceptance criteria for purity and impurities. It specifies that Acetylcholine Chloride must contain between 98.0% and 102.0% of the compound on a dried basis, along with detailed procedures for assays and additional requirements for packaging and storage. The document is officially recognized as of May 1, 2020, and includes references to relevant USP standards.

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Ciprian
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Printed on: Wed Feb 08 2023, 11:42:33 PM(EST) Status: Currently Official on 09-Feb-2023 DocId: GUID-5C8CFBDB-08A5-4216-8DB2-2F8BE7547C1E_2_en-US

Printed by: Dang Van Vu Official Date: Official as of 01-May-2020 Document Type: USP @2023 USPC
Do Not Distribute DOI Ref: 286kb DOI: https://doi.org/10.31003/USPNF_M680_02_01
1

excess alkali with 0.1 N sulfuric acid VS. Perform a blank


Acetylcholine Chloride determination (see Titrimetry á541ñ, Residual Titrations).
Each mL of 0.1 N sodium hydroxide is equivalent to
18.17 mg of C7H16ClNO2.
Acceptance criteria: 98.0%–102.0% on the dried basis
C7H16ClNO2 181.66 OTHER COMPONENTS
Ethanaminium, 2-(acetyloxy)-N,N,N-trimethyl-, chloride; • CONTENT OF CHLORIDE
Choline acetate (ester) chloride CAS RN®: 60-31-1; UNII: Sample: 280 mg of Acetylcholine Chloride
AF73293C2R. Analysis: Dissolve the Sample in 140 mL of water, and add
DEFINITION 1 mL of dichlorofluorescein TS. Titrate with 0.1 N silver
Acetylcholine Chloride contains NLT 98.0% and NMT 102.0% nitrate VS until the silver chloride flocculates and the
of acetylcholine chloride (C7H16ClNO2), calculated on the mixture acquires a faint pink color. Each mL of 0.1 N silver
dried basis. nitrate is equivalent to 3.545 mg of Cl.
Acceptance criteria: 19.3%–19.8% of Cl on the dried basis
IDENTIFICATION
IMPURITIES
Change to read: • RESIDUE ON IGNITION á281ñ: NMT 0.2%
• A. ▲SPECTROSCOPIC IDENTIFICATION TESTS á197ñ, Infrared SPECIFIC TESTS
Spectroscopy: 197K▲ (CN 1-May-2020) • MELTING RANGE OR TEMPERATURE, Class I á741ñ: 149°–152°
• B. • ACIDITY
Sample solution: 100 mg/mL in water Sample: 100 mg of Acetylcholine Chloride
Analysis: Dissolve the Sample in 10 mL of recently boiled

al
Analysis: To 5 mL of Sample solution add 5 mL of silver
nitrate TS. water, and add at once 1 drop of bromothymol blue TS.
Acceptance criteria: A white, curdy precipitate, which is Acceptance criteria: NMT 0.50 mL of 0.010 N sodium
soluble in ammonium hydroxide but insoluble in nitric acid, hydroxide is required to produce a color change.
is formed. • LOSS ON DRYING á731ñ
Analysis: Dry a sample at 105° for 3 h.
ASSAY
• PROCEDURE
Sample: 400 mg of Acetylcholine Chloride
ci Acceptance criteria: NMT 1.0%
ADDITIONAL REQUIREMENTS
• PACKAGING AND STORAGE: Preserve in a tight container,
Analysis: Dissolve in 15 mL of water in a glass-stoppered
conical flask, add 40.0 mL of 0.1 N sodium hydroxide VS, and store at controlled room temperature.
• USP REFERENCE STANDARDS á11ñ
ffi
and heat on a steam bath for 30 min. Insert the stopper,
allow to cool, add phenolphthalein TS, and titrate the USP Acetylcholine Chloride RS
O

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