PHR2814
替勃龙
certified reference material, pharmaceutical secondary standard
别名:
(7α,17α)-17-Hydroxy-7-methyl-19-norpregn-5(10)-en-20-yn-3-one
SMILES string
O[C@@]1([C@@]2([C@H]([C@H]3[C@H](CC2)C4=C(C[C@H]3C)CC(=O)CC4)CC1)C)C#C
InChI
1S/C21H28O2/c1-4-21(23)10-8-18-19-13(2)11-14-12-15(22)5-6-16(14)17(19)7-9-20(18,21)3/h1,13,17-19,23H,5-12H2,2-3H3/t13-,17-,18+,19-,20+,21+/m1/s1
InChI key
WZDGZWOAQTVYBX-XOINTXKNSA-N
grade
certified reference material, pharmaceutical secondary standard
agency
traceable to Ph. Eur.
API family
tibolone
packaging
pkg of 200 mg
mp
165-169 °C
application(s)
pharmaceutical
storage temp.
2-8°C
Quality Level
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General description
Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards
Tibolone is a synthetic steroid with weak estrogenic, androgenic, and progestogenic activity used in the treatment of menopausal syndrome. Tibolone and its metabolites induce prolactin production in human endometrial stromal cells in vitro. Sulfation plays a major role in the metabolism and regulation of the tissue-specific activity of tibolone and its metabolites.
Application
These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.
Analysis Note
These secondary standards offer multi-traceability to the USP and EP primary standards, where they are available.
Other Notes
This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.
signalword
Warning
hcodes
Hazard Classifications
Eye Irrit. 2
存储类别
11 - Combustible Solids
wgk
WGK 3
flash_point_f
Not applicable
flash_point_c
Not applicable
法规信息
监管及禁止进口产品
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