Amylene Hydrate
C5H12O 88.15
2-Butanol, 2-methyl-;
tert-Pentyl alcohol
[75-85-4].
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C5H12O 88.15
2-Butanol, 2-methyl-;
tert-Pentyl alcohol
[75-85-4].DEFINITION
Amylene Hydrate contains NLT 99.0% and NMT 100.0% of C5H12O.
IDENTIFICATION
• 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.
ASSAY
• Procedure
Sample solution:
Amylene Hydrate
Chromatographic system
Mode:
GC
Detector:
Thermal conductivity
Column:
4-mm × 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
Analysis
Sample:
Sample solution
From the area under the curve, calculate the percentage (a/a) of C5H12O in the Amylene Hydrate taken.
Acceptance criteria:
99.0%–100.0%
IMPURITIES
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%).
for 1 h, weighs NMT 2 mg (0.02%).
• Heavy Metals, Method I 
231
231
Sample solution:
Evaporate 5.0 mL (4 g) on a steam bath to dryness, warm the residue gently with 1 mL of dilute hydrochloric acid (1 in 120), add water to make 25 mL, and filter, if necessary.
Acceptance criteria:
NMT 5 ppm
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.
SPECIFIC TESTS
• Specific Gravity 841:
0.803–0.807
841:
0.803–0.807
• Distilling Range, Method I 721:
It distills completely at between 97 and 103, a correction factor of 0.037/mm being applied as necessary.
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.
for 10 min.
Acceptance criteria:
No darkening occurs.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Robert H. Lafaver, M.S.
Scientific Liaison 1-301-816-8335 |
(EXC2010) Monographs - Excipients |
USP35–NF30 Page 1700
Pharmacopeial Forum: Volume No. 35(4) Page 903