Trenbolone Acetate
(tren' boe lone as' e tate).
C20H24O3 312.40 Estra-4,9,11-trien-3-one, 17-(acetyloxy)-, (17)-; 17-Hydroxyestra-4,9,11-trien-3-one, acetate [10161-34-9]. DEFINITION
Trenbolone Acetate contains NLT 97.0% and NMT 103.0% of C20H24O3, calculated on the dried basis.
IDENTIFICATION
• B.
The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay.
ASSAY
• Procedure
Diluent:
Acetonitrile, methanol, water, and acetic acid (36.5:30:33.5:0.1)
Solution A:
Acetonitrile, methanol, and water (36.5:30:33.5)
Solution B:
Acetonitrile and methanol (9:1)
Mobile phase:
See the gradient table below.
Standard solution:
1 mg/mL of USP Trenbolone Acetate RS in Diluent. Sonicate, if necessary, to dissolve.
Sample solution:
1 mg/mL of Trenbolone Acetate in Diluent. Sonicate, if necessary, to dissolve.
Chromatographic system
Mode:
LC
Detector:
UV 229 nm
Column:
4.6-mm × 10-cm; 3-µm packing L1
Flow rate:
1.0 mL/min
Injection size:
5 µL
System suitability
Samples:
Standard solution
Suitability requirements
Relative standard deviation:
NMT 2.0%
Analysis
Samples:
Standard solution and Sample solution
Calculate the percentage of C20H24O3 in the portion of Trenbolone Acetate taken:
Result = (rU/rS) × (CS/CU) × 100
Acceptance criteria:
97.0%103.0%, on the dried basis
IMPURITIES
Inorganic Impurities
• Residue on Ignition 281:
NMT 0.1%
Organic Impurities
• Procedure
Diluent, Solution A, Solution B, Mobile phase, Standard solution, Sample solution and Chromatographic system:
Proceed as directed in the Assay.
System suitability solution:
1 mg/mL of USP Trenbolone Acetate System Suitability Mixture RS in Diluent. Sonicate, if necessary, to dissolve.
System suitability
Samples:
Standard solution and System suitability solution
[NoteThe relative retention times for trenbolone acetate related compound A and trenbolone acetate are 1.2 and 1.0, respectively. ]
Suitability requirements
Resolution:
NLT 3.0 between trenbolone acetate and trenbolone acetate related compound A, System suitability solution
Column efficiency:
NLT 8000 theoretical plates for the trenbolone acetate peak, System suitability solution
Relative standard deviation:
NMT 2.0%, Standard solution
Analysis
Sample:
Sample solution
Calculate the percentage of each impurity in the portion of Trenbolone Acetate taken:
Result = (100 × rU)/[(rS + S) × F]
Acceptance criteria
Individual impurities:
See Impurity Table 1.
Total specified and unspecified impurities:
NMT 2.0%
Reporting level for impurities:
NMT 0.10%
Impurity Table 1
SPECIFIC TESTS
• Absorbance
Sample solution:
100 mg/mL in dehydrated alcohol
Spectrometric conditions
Analytical wavelength:
440 nm
Cell:
2 cm
Blank:
Dehydrated alcohol
Analysis
Samples:
Sample solution and Blank
Acceptance criteria:
NMT 0.3
• Optical Rotation, Specific Rotation 781S:
+39 to +43
Sample solution:
5 mg/mL in methanol
• Loss on Drying 731:
Dry a sample in a vacuum at 60 for 2 h: it loses NMT 0.5% of its weight.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers, and store in a refrigerator.
• Labeling:
Label it to indicate that it is for veterinary use only.
• USP Reference Standards 11
USP Trenbolone Acetate RS
USP Trenbolone Acetate System Suitability Mixture RS
Mixture containing trenbolone and conjugated dihydrotrenbolone acetate in a matrix of trenbolone acetate.
Auxiliary Information
Please check for your question in the FAQs before contacting USP.
USP35NF30 Page 4919
Pharmacopeial Forum: Volume No. 35(1) Page 100
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