Amylene Hydrate

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

DOWNLOAD PDF HERE

C₅H₁₂O      88.15

2-Butanol, 2-methyl-;

tert-Pentyl alcohol CAS RN: 75-85-4.

1 DEFINITION

Amylene Hydrate contains NLT 99.0% and NMT 100.0% of C₅H₁₂O.

2 IDENTIFICATION

Change to read:

A. SPECTROSCOPIC IDENTIFICATION TESTS (197), Infrared Spectroscopy: 197F (CN 1-MAY-2020)

B. PROCEDURE

• Sample solution: 1 in 10
• Analysis: To 10 mL of the Sample solution quickly add 5 mL of a 1-in-100 solution of vanillin in sulfuric acid.
• Acceptance criteria: A violet-red color is produced.

3 ASSAY

3.1 PROCEDURE

3.1.1 Sample solution

Amylene Hydrate

3.1.2 Chromatographic system

Mode: GC

Detector: Thermal conductivity

Column: 4-mm x 2-cm glass column; packed with chromatographic support S2 (under typical conditions)

Temperature

• Column: 190°
• Injector: 200
• Detector block: 200°

Carrier gas: Helium

Flow rate: 50 mL/min

Injection size: 0.4 µL

3.1.3 Analysis

Sample: Sample solution

From the area under the curve, calculate the percentage (a/a) of C,H,O in the Amylene Hydrate taken.

3.1.4 Acceptance criteria

99.0%-100.0%

4 IMPURITIES

4.1 Inorganic Impurities

LIMIT OF NONVOLATILE RESIDUE

Sample: 10 mL

Analysis: Evaporate the Sample in a tared porcelain dish on a steam bath to a volume of about 1 mL, and allow it to evaporate spontaneously to dryness while protected from dust.

Acceptance criteria: The residue, if any, is colorless, and when dried at 105° for 1 h, weighs NMT 2 mg (0.02%).

4.2 Organic Impurities

PROCEDURE

Sample solution: 1 in 20

Analysis: To 10 ml of the Sample solution add 0:10 ml of 0.10 N potassium permanganate

Acceptance criteria: The pink color does not completely disappear within 10 min.

4.3 SPECIFIC TESTS

SPECIFIC GRAVITY (841): 0.803-0.807

DISTILLING RANGE, Method/(721); It distills completely at between 97° and 103°, a correction factor of 0.037°/mm being applied as necessary.

WATER: The relative retention time of water on the gas chromatographic column used in the Assay is approximately 0.2 times that of Amylene Hydrate. From the area under the curve obtained in the Assay, calculate the percentage (a/a) of water in the Amylene Hydrate taken: NMT 0.5% is found.

ALDEHYDE

• Sample solution: 1 in 20
• Analysis: To 10 mL of the Sample solution add 1 mL of silver-ammonium nitrate TS, and heat the mixture on a water bath at 60 for 10 min.
• Acceptance criteria: No darkening occurs.

5 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in tight containers.